Open Positions

Associate Director, Clinical Pharmacology

Associate Director, Clinical Pharmacology

Job Description

Position Overview:

The ideal candidate will work closely with the Global Project Teams to create and implement clinical pharmacology strategies to support the successful discovery of differentiated medications. You will apply state-of-the art Clinical Pharmacology and Model-Based Drug Development (MBDD) approaches to guide decision-making at the project team level across all phases of research including non-clinical and early to late-stage clinical development programs. The individual must be collaborative and team-oriented and enjoy the fast-paced, multi-tasked, and hands-on research environment of a science- and patient-centric company.

Responsibilities:

  • Demonstrated hands-on expertise in application of PK/PD modeling and simulation, including use of biomarkers, for clinical decision-making
  • Accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at internal (project/governance) and external interactions (investigator meeting/conference/health authorities)
  • Capable of integrating pharmacokinetic, pharmacodynamic, and safety data from multiple sources to optimize dosing for patient populations across the development continuum will be essential.
  • Provide input on preclinical-stage programs to optimize preclinical efficacy and biomarker data to support the advancement of programs into clinical development and the submission of Investigational New Drug applications
  • Provide input on clinical-stage programs, integrating PK/PD and biomarker data and providing recommendations for decision-making of Phase I-III clinical programs
  • Lead the preparation of standalone PK/PD reports and PK/PD sections of Clinical Study Reports (CSR) and regulatory submissions
  • Contribute to clinical pharmacology sections of clinical study protocols, study analysis plans, clinical study reports and clinical development plans
  • Works closely with colleagues in Research, Biometrics, Clinical Development and with external partners to ensure advanced modeling and simulation approaches (e.g., QSP, MBDD) inform internal decisions and external regulatory interactions
  • Collaborate with clinical operations, Research bioanalytical scientists, Biometrics, and Clinical Development to ensure the efficient execution of Phase I-III studies
Qualifications

Education and Experience:

  • PhD degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics or PharmD with 5-7 years of industry or equivalent experience in Clinical Pharmacology or Quantitative Systems Pharmacology
  • Strong theoretical background and hands-on experience interpreting non-clinical and clinical dose-response and PK/PD data to inform clinical study designs and drug development decision-making is required
  • Proficiency with analysis software (e.g., WinNonlin, Phoenix NLME, NONMEM, or other commonly used platforms) strongly preferred
  • Prior experience in PK and PK/PD of large molecules and/or vaccine therapeutics is preferred
  • Knowledge and experience with regulatory guidance related to clinical pharmacology
  • Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Excellent organizational, documentation, and communication skills; critical thinking and the ability to work well in a team
  • Ability to lead and work with others in a positive and collaborative manner
  • Analytical and excellent problem-solving skills
  • High competence in common software and data analysis packages (eg, SoftMax Pro, GraphPad Prism, Microsoft Office, PowerPoint, Excel, Word). Knowledge of JMP a plus

_________________________________________________________________________

More information about Prothena can be found at the Company’s website: www.prothena.com

About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Associate Director/Director, Clinical Data Management

Associate Director/Director, Clinical Data Management

Job Description

The Associate Director/Director is responsible for assigning and overseeing Data Management (DM) operational activities for assigned programs with assigned staff and for ensuring compliance with the corporate timeline(s) and scope(s) of work outsourced to the DM service provider(s) and coordinating activities from other external vendors that may also provide study data. This includes but is not limited to vendor and technology evaluation, qualification and selection, training and oversight for all DM services from study start-up through study close-out, final reporting and archiving of all study files.

Responsibilities:

  • Serve as Data Management Program Lead for assigned studies and coordinate with DM Study Leads to ensure consistent processes and data collection management across all studies.
  • Serve as point of escalation for both DM staff, internal study teams and external data vendors across assigned programs.
  • Lead and manage DM related activities outsourced to DM service provider(s) as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up through study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met with high data quality on time and within budget. 
  • Provide operational leadership to the strategic direction, planning, execution, collection and handling of all clinical data (including but not limited to DMP, CRF design, completion guidelines, edit checks, coding conventions, SAE reconciliation, interim/database lock procedures, data listings) to the highest quality standards while ensuring alignment with other ongoing studies.
  • Oversee and manage data reviews with cross-functional team to the internal data review plan, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed.
  • Actively participate in development, review and implementation of study documents from other functional groups (e.g. Vendor Oversight and Communication, Clinical Monitoring, Biostatistics, etc.)
  • Provide oversight to assigned DM(s) to develop study-specific reporting metrics to be reported regularly to cross-functional team on study data status, completeness and cleanliness, conduct internal UAT, coordinating the clinical team’s testing of clinical study databases and database changes to match CRFs according to the protocol, other studies and company standards.
  • Review study data for completeness and general clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations.
  • Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times.
  • Lead vendor and technology evaluations, qualifications and selections, including development of outsourcing strategies for DM services and to the establishment of partnerships with key vendors.
  • Lead development of DM RFPs, contract/MSA and budget negotiations, scope changes and invoicing for DM vendor on assigned studies, including identification of potential changes needed as a result of execution of study operations.
  • Provide subject matter expertise with regard to data collection, cleaning, reporting and transfer for vendor audits for DM services and for other external data providers.
  • Develop SOPs, working practices, DM standards/templates with a focus on CDISC CDASH implementation, policies and Clinical Development process improvement supporting clinical data management activities for best practices and quality data.
  • Ensure SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical Data Management Practices internally and with DM and other external data providers.
  • Manage department personnel and ensure successful study execution and cross-department collaboration with internal and external stakeholders.
  • Provide historical data to key stakeholders for other business-related projects/programs.
Qualifications

Education and/or Experience:

  • Bachelor’s degree in a relevant scientific discipline or equivalent
  • Minimum of twelve years of relevant clinical data management experience and a minimum of 7 years’ experience as a Lead Study Data Manager across phase 1-4 clinical trials
  • Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries).
  • Experience managing vendors and data management activities from study start-up through closure is required
  • Ability to use judgement based upon standards and policies to problem solve, meet timelines and provide alternative solutions
  • Knowledge and experience with various clinical databases, key technologies (e.g., EDC, IVRS/IWRS, central labs, ecg); Knowledge of MRI/PET imaging and data a plus
  • Knowledge of CDISC standards (CDASH and SDTM)
  • Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines is required
  • Must be willing to travel as required

 

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Excellent communication, written and interpersonal skills
  • Self-sufficient and able to work within a multi-disciplinary team with minimal oversight
  • Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
  • Past line management experience required
  • Able to cultivate effective and productive working relationships with colleagues, subordinates, vendors and management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.
  • Able to prioritize and handle multiple tasks and studies simultaneously
  • Proficiency with MS Word, Excel, Outlook, and PowerPoint
  • Knowledge of SAS programming and Visio is a plus

______________________________________________________________________________

More information about Prothena can be found at the Company’s website: www.prothena.com.

About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Director, Corporate Communications

Director, Corporate Communications

Job Description

Position Overview:

Prothena is seeking an entrepreneurial, motivated, and strategic Director of Corporate Communications who dares to be different in order to unleash its vast potential and ensure Prothena is best positioned in the eyes of the media, scientific and medical thought leaders, patients, payors, and other stakeholder communities. As Director of Corporate Communications, you will be assisting in building and executing Prothena's communications strategy and will have the opportunity to build and help lead the global communications function as the company continues to develop its leading protein dysregulation pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases and prepares for the potential commercialization of Birtamimab. He or she will create, develop, and execute a comprehensive internal and external communications plan that enhances Prothena's corporate brand experience and identity.  Reporting to the SVP, Corporate Affairs, the Director of Corporate Communications will be a key advisor to leadership and partner to the SVP, Corporate Affairs.

Top priorities include:

  • Partnering with the SVP, Corporate Affairs to further define, refine, optimize, and make more concise the communication of Prothena's corporate strategy and mission to make a real impact for patients
  • Establishing, as needed, and building strong proactive partnerships with public relations vendor(s) to ensure Prothena's visibility in the neurodegeneration space with the media and all relevant stakeholders
  • Partnering with research and medical to help unify communications highlighting scientific publications and strengthen Prothena's reach with KOLs and patient communities.

Responsibilities:

GLOBAL COMMUNICATIONS AND PUBLIC RELATIONS

  • Develop and execute a corporate communications strategy that differentiates the company's product candidates and raises corporate brand awareness in alignment with global organizational and operational goals.
  • Collaborate cross-functionally by integrating input from early research through commercial to create and manage a global messaging platform for use in all external and internal messaging around Prothena's unique scientific approach and pipeline.
  • Serve as a liaison and contact person for the media community; act as company spokesperson when needed and direct the work of external agencies to develop global PR strategy, conduct proactive outreach to journalists, arrange interviews, and prepare executive spokespersons.
  • Partner collaboratively with Strategy, HR, IR, Research, and other functions to develop and execute all communications - such as internal and external announcements, including scientific and financial press releases, corporate presentations and scripts for investor conferences and R&D Days, Q&A documents, annual reports, and other SEC filings.
  • Develop and implement a crisis communications practice and playbook as part of the current business continuity plan and efforts.
  • Manage the development, review, and distribution of press releases, messaging documents, and other communications materials, such as presentations, videos, or other multimedia tools related to scientific and corporate announcements.
  • Partner closely with Medical Affairs to build a key opinion leader and influencer network worldwide by cultivating relationships and elevating Prothena's story through rich and relevant commentary on strategically important key issues and topics.
  • With a strong understanding of the business and related science, develop a plan to execute on opportunities and mitigate risks which could impact Prothena's strategic goals. Implement a methodology to define success; measure and monitor internal and external communications effectiveness and results across the organization.

SOCIAL & DIGITAL COMMUNICATIONS

  • Oversee the creation and implementation of a Digital Road Map (including social media outlets) and work collaboratively with stakeholders to ensure digital assets have a cohesive voice reflecting the company mission, vision, and values; oversee management of the existing corporate website and build of a corporate newscenter.
  • Own social media editorial calendars for existing channels (LinkedIn, Twitter) and lead channel and content strategy.
  • Manage social software tools (platform, listening, metrics). In partnership with external agency and internal stakeholders, develop paid media strategy.

SCIENTIFIC & MEDICAL COMMUNICATIONS

  • Develop corporate communications plans for scientific conferences, scientific presentations, research publications, and pipeline/product updates to ensure consistency of messaging across all platforms.
  • Partner closely with medical affairs and program project teams to execute on disease awareness and patient advocacy campaigns.
  • Liaise with medical affairs to build relationships and communications plans with global advocacy groups.

CORPORATE BRANDING & INTERNAL COMMUNICATIONS

  • Develop, implement, and manage Prothena's corporate brand strategy and positioning; influence cross-functional teams to align campaigns and communications programs with this plan.
  • Act as a strategic advisor to business partners across the company and work collaboratively with various teams to accomplish short- and long-term goals, including clear communication using Prothena's brand standards for marketing, pre-launch, launch, recruiting, employee engagement, and other activities.
  • Collaborate with the HR team to engage employees in understanding Prothena's story through innovative internal communications and employee engagement initiatives
Qualifications

Education and Experience:

  • Bachelor’s degree required
  • 7+ years of corporate communications experience in a corporate and/or public relations/marketing agency setting with biotechnology/biopharmaceutical/pharmaceutical expertise (ideally including global, fully integrated, commercial-stage biopharma/pharma companies), leading the strategic direction and successful execution of such programs
  • Experience working collaboratively with media and through traditional and social communication channels
  • Well-equipped to understand the science and business strategy sufficiently (on key topics such as corporate brand creation and product marketing) to identify issues and effectively communicate with all internal and external stakeholders, including media, scientific and medical thought leaders, patients, payors, and other relevant audiences 

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Exceptional verbal, written communication (writing, proofreading, editing), and interpersonal skills that enable relationships to flourish - possesses the ability to develop trust and confidence across all levels and functions
  • Operate with speed, intention, focus, and the ability to act decisively in ambiguous situations, taking risks after establishing the ROI of the initiative/effort
  • Thrive working in a fast-paced, innovative culture while remaining nimble, pragmatic, and resourceful to drive solutions for unique and complex problems that have a broad impact on the business
  • An inherent sense of urgency that enables a proactive, consultative approach to seize opportunity, influence others, and overcome challenges
  • Strong business acumen and capability to influence and negotiate with great latitude on outcomes
  • An analytical thinker and decision maker, especially on complex issues, as well as problem solver with practical and sensible solutions
  • Ability to think strategically as well as execute with attention to detail
  • Ability to grasp and implement new concepts in a timely fashion leveraging excellent time/project management skills
  • Thrive in a results-driven, highly accountable environment where you can make a clear impact and be excited to build
  • A trusted, team player who listens effectively and invites response and discussion
  • Ability to work with the highest level of ethical and professional values in a matrixed environment
About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Director, Head of Medical/Regulatory Writing

Director, Head of Medical/Regulatory Writing

Job Description

Position Overview:

The Director, Head of Medical/Regulatory Writing, reporting to the Senior Director, Global Regulatory Portfolio Management, will be responsible for leading the development, writing and document management of clinical/regulatory documents in support of IND/CTA/BLA/MAA regulatory filings and health authority interactions, in collaboration with subject matter experts and program teams. As the head of Medical/Regulatory Writing, the successful candidate will oversee the selection and management of contract medical writers and organizations.

Responsibilities:

  • In collaboration with key functional leaders of program teams, including Regulatory Affairs, Clinical Development, Clinical Operations and Research/Translational Sciences to plan, develop, and deliver high quality documents aligned with development program strategies and timelines
  • Lead the preparation, review, QC, and finalization of key documents including clinical synopses, protocols and study reports, investigator brochures, modules/sections of INDs/CTAs/BLAs/MAAs, briefing packages and responses to regulatory agency requests, as needed
  • Manage outsourcing of document preparation, including writing, editing, review and QC by effectively planning, screening, and allocating contract writers to ensure corporate and program objectives are met, in collaboration with global program teams and key functional areas
  • Effectively manage the simultaneous preparation of multiple documents across development programs at various stages of development to ensure timely document completion in accordance with respective program strategies
  • Develop and maintain the proper template for the appropriate documents and ensure the consistency between programs where needed. When appropriate, apply lessens learned from one program to others to increase efficiency and accuracy in document writing
  • Establish, maintain, and update medical writing SOPs, templates, style, and review guidelines as needed to facilitate the preparation and timely completion of high-quality documents and to maintain consistency across development programs
Qualifications

Education and Experience:

  • Advanced or bachelor’s degree in a scientific discipline; life sciences preferred
  • >7 years of writing experience, preferably with at least 3-5 years in a pharmaceutical or biotechnology company focused on novel therapies
  • Demonstrated hands on experience in the preparation, review and completion of key clinical and regulatory documents, including clinical protocols and study reports, investigator brochures, briefing documents
  • Well versed in ICH guidelines for regulatory submissions (INDs/CTAs/BLAs/MAAs) and associated regulatory documents including clinical protocols/study reports and investigator brochures
  • Track record of effective collaboration on project teams, and across multiple organizational levels and functions

Competencies and Attributes:

  • Ability to build and maintain effective internal and external relationships, including cross-functional teams, individual contractors and contract research organizations
  • Exceptional written and verbal communication skills and attention to detail essential; must display strong analytical and problem-solving abilities
  • Excellent planning and organizational skills, including the ability to support and prioritize multiple projects, as needed
  • Demonstrated strength in understanding and effectively applying current regulatory requirements in an emerging regulatory landscape
  • Maintains expert working knowledge of applicable FDA/EMA regulations and ICH guidelines
  • Proficient in platforms including Box and One Drive for the management of document review
  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Director/Sr. Director, Global Program Manager

Director/Sr. Director, Global Program Manager

Job Description

Position Overview:

Reporting to the Senior Vice President of Portfolio & Alliance Management, the Global Program Manager (GPM) will be responsible for managing multifunctional Global Product Teams (GPTs) as well as external collaboration Joint Development Teams (JDTs).  In partnership with an assigned Product Team Leader, the GPM will drive the development and execution of the strategic plans for the global development and commercialization of product(s). 

The GPM role requires strong scientific knowledge and drug development experience as well as an ability to thrive in a dynamic and entrepreneurial environment.  Additionally, the GPM role is highly visible in the organization and offers an opportunity to make significant contributions towards Prothena’s goals of delivering innovative therapies for patients.

Responsibilities:

  • Global Product Team Management - Partners with Product Team Leader in the conduct/facilitation of Program Team meetings, ensuring minutes, action items, and deliverables are documented and achieved.
  • Alliance/Collaboration Management – Partners with Product Team Leader in the management of joint team structures and development plans to drive long-term value from business relationships. GPM ensures the collaboration operates per the established contractual agreement.
  • Operational Leadership - Acts as the operational leader of the GPT and JDT. Responsible for ensuring that the team(s) executes on time and within agreed-upon parameters outlined in the program’s integrated project plan.
  • Planning and Execution - Ensure program strategic and tactical plans and goals are developed, aligned, approved and implemented cross-functionally and globally. Specifically, the GPM is responsible for working with the GPT to generate and proactively manage a cross-functional, integrated project plan, which aligns with the approved program strategy. 
  • Decision Making - Drive the decision-making process within the program, ensuring team and cross-functional alignment.
  • Risk Management - Proactively identify and manage program risks and issues with GPT members and stakeholders, including updating and/or escalation to executive leadership for information or action, when appropriate.
  • Program Information & Communication - Ensures all GPT members understand Program goals and objectives, current program plans and schedules, critical path activities and risks. Communicates, documents and archives project team activities and decisions. Prepare and present clear communications for senior management including program reporting/dashboards.
  • Functional Initiatives - Supports other departmental initiatives, including GPT governance, business process design, and functional area initiative support.
Qualifications

Education and Experience:

  • B.S./M.S. degree or higher, preferably in Life Sciences.
  • 3+ years program management experience leading complex, pharmaceutical projects in multi-disciplinary, global environments.
  • 5+ years of in-depth pharmaceutical/biotech industry experience with exposure to all phases of drug development; working knowledge of neuroscience therapeutic area preferred
  • Demonstrated ability to work effectively in a nimble fast-paced matrixed environment.
  • Demonstrated ability to work with Program teams to develop, implement and deliver on Program goals.
  • Demonstrated ability to positively and constructively drive strategic problem solving and program decision making.
  • Proficient with Microsoft Office (e.g. Word, PowerPoint, Excel) and Microsoft Project. Project Management Professional (PMP) certification is a plus.

Competencies and Attributes:

  • Exceptional program/project management planning and execution skills.
  • Excellent written and verbal communication, group facilitation and team management skills; strong presentation skills.
  • Ability to manage multiple projects simultaneously with proven delivery.
  • Self-organized with strong critical thinking and analytical skills.
  • Strong, collaborative, interpersonal skills with the ability to develop relationships with stakeholders and manage team conflict.
  • Goal-oriented with an innate ability to translate between short-term tactical plans and goals, and long-term objectives and strategies.
  • Professional attitude with strong decision-making skills and ability to work calmly in a high intensity and dynamic environment.
  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful

_________________________________________________________________________

More information about Prothena can be found at the Company’s website: www.prothena.com.

About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Director, Statistical Programming

Director, Statistical Programming

Job Description

Position Overview:

This essential team member will be responsible for managing the statistical programming efforts for all projects and studies, including overseeing the developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of SAS programming standards and procedures.

Responsibilities:

To perform this job successfully an individual must be able to perform each essential function satisfactorily.

  • Ensure departmental or functional training plans in place and appropriate.
  • Demonstrate excellent leadership skills within department. This includes taking an active role in departmental and company activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate.
  • Train and mentor new managers.
  • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
  • Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
  • Perform vendor qualifications in regards to statistical programming functions and manage CROs regarding programming issues and activities to ensure on time deliverables within budget.
  • Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
  • Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications.
  • Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Manage datasets and output across SAS programs, studies, and indications to ensure consistency.
  • Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests.
  • Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Develop and/or maintain departmental procedures and standards.
  • Adhere to departmental and regulatory agency procedures and standards.
  • Review CRFs, edit check specifications, and table, figure, and listing mock-ups.
  • Manage, generate, and/or review blankCRF, define.xml, and define.pdf documents.
  • Works effectively with cross functional groups, study team, and vendors.
  • Assist in validation of SAS per 21 CFR Part 11.
  • Train and mentor new programmers.
  • Supervise contract programmers as necessary.
  • Assist in creation of table, figure, or listing mockups under supervision of statisticians.
  • Other duties as assigned.
Qualifications

Education /Experience

  • Bachelor’s degree or Master’s degree in Statistics, Mathematics, or Computer Science or in a related field. 
  • Minimum of 12 years Biotechnology/Pharmaceutical/CRO industry experience as a statistical programmer. 
  • Minimum of 7 years’ experience as a lead statistical programmer for a clinical study. 
  • Prior experience managing a statistical programming team required.
  • Extensive knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.
  • eCTD NDA submission experience is a must.

 Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Strong verbal and written communication skills are essential.
  • Excellent organization and multi-tasking skills.
  • Exceptional interpersonal skills and problem solving capabilities.
  • Proven meeting planning skills.
  • Ability to work effectively across a matrix organization.
  • Ability to work independently and prioritize with minimal daily instruction.
  • Ability to think strategically in order to improve current processes.

________________________________________________________________________________

More information about Prothena can be found at the Company’s website: www.prothena.com.

About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Manager, FP&A (CMC)

Manager, FP&A (CMC)

Job Description

Position Overview:

The Manager, FP&A provides support for all financial aspects related to month end close, reporting results, budgeting/forecasting, modeling, and analytical and strategic support for the Technical Operations (CMC) and Commercial groups.  Other duties include, but are not limited to, monitoring and analysis of end-to-end spending for external expenses, and reviewing contracts and vendor payments. 

Responsibilities:

  • Work collaboratively with the Tech Ops and Commercial teams to ensure that the data necessary to accurately monitor and report on spending, accruals, budgets, and forecasts is collected, maintained, and analyzed in a timely manner. 
  • Work closely with Accounting on the month end and quarter end close processes, including accruals, reconciliations, etc.
  • Maintain organized set of detailed records and files to document and support financial transactions.
  • Perform analysis of processes related to spending and accruals in accordance with GAAP / SOX compliance.
  • Collaborate with finance management and business partners to develop annual budget, forecast, financial reviews for actual versus budget/forecast, and ad-hoc analysis
  • Establish and maintain relationships with key internal and external stakeholders and help troubleshoot finance-related issues.
  • Monitor end-to-end spending from expenditure purchase order request to vendor invoicing.
  • Review vendor contacts and payment terms as needed.
  • Perform other duties as assigned or required.
Qualifications

Education and/or Experience:

  • BA/BS in business, accounting, or related field, MBA preferred
  • A minimum of 3 – 5 years’ experience in accounting and finance
  • Experience supporting CMC in the Biotech/Pharmaceutical industry preferred
  • Experience in business partnering role, including understanding of functional area roles, responsibilities, and interdependencies of the drug development process through commercialization
  • Understanding of accrual accounting as it relates to drug development / life sciences
  • Excellent interpersonal skills and the ability to work effectively with multiple functional areas in a collaborative, team environment.
  • ERP experience preferred
  • Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.  Advanced excel skills, including the development and use of pivot table and lookup features
  • Competencies and Attributes:

    • Demonstrated leadership ability to drive results that are needed to achieve the company objectives in accord with the Prothena core cultural values of courageous, imaginative, joyful, and selfless
    • Demonstrated ability and commitment to meet tight deadlines and multitasking
    • Results oriented with strong accounting, financial skills
    • Strong analytical skills
    • Strong organization, time management skills and attention to detail
    • Excellent verbal and written communication skills, demonstrating the ability to communicate effectively with employees of different levels
    • Excellent team work and collaboration skills
About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Medical Director, Safety Physician

Medical Director, Safety Physician

Job Description

The Medical Director, Safety Physician will provide broad support of activities requiring medical safety input for assigned investigational medical products in the Prothena portfolio, preparing for commercialization and post-marketed environment.  The individual will lead periodic safety governance meetings and safety signaling reviews, as well as collaborate closely with individual case review physicians on a regular basis, along with assuming primary responsibility for aggregate safety data.  The individual will work closely with internal stakeholders such as Safety Operations, Clinical Physician Leads and Global Regulatory colleagues to support authoring and review of clinical and regulatory documents related to safety analysis.   He/she will lead safety strategy in cross-functional teams/programs to ensure ongoing favorable benefit-risk profile of assigned IMP(s) in the Prothena portfolio.

Responsibilities

  • Represent department as Medical Safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
  • Lead Safety Governance and present safety data to drive aggregate safety data evaluation and discussion of the results with the Global Head of Safety and PV and other key stakeholders
  • Appropriately elevate signal detection findings impacting assigned products benefit/risk profile.
  • Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (DSUR, PADER, PBRER/PSUR) and ad hoc safety assessments.
  • Provide oversight for the safety aspects for clinical studies, including participation at DMC meetings.
  • Collaborate with Safety Medical Reviewers of ICSRs to maintain favorable benefit-risk profile of compound(s).
  • Lead development of Risk Management Plans with emphasis on driving characterization of identified and potential risks.
  • Maintain knowledge of global regulatory authority regulations including FDA and EMA.
Qualifications
  • MD degree or equivalent with clinical post-training and/or relevant scientific experience
  • A minimum of ~ 8-10 years of relevant drug safety experience in the biotechnology/pharmaceutical/CRO industry, including safety leadership experience.
  • Thorough understanding of domestic (U.S.) and global pharmacovigilance regulations, GCP & ICH guidelines.
  • Working knowledge of validated drug safety databases (e.g., ARGUS) as well as competency with MedDRA
  • Demonstrated ability to mentor and coach others
  • Strong understanding of medical concepts, drug development, pharmacovigilance, risk management and global regulatory safety and risk management health authority requirements
  • Ability to effectively lead and work well within cross-functional teams, using strong organizational, facilitation, and interpersonal communication skills.
  • Attention to detail along with excellent scientific and analytical skills.
  • Demonstrated ability to understand, research, independently investigate, interpret, and reach reasoned conclusions regarding complex medical-scientific data from a broad range of disciplines, e.g., clinical trial laboratory data, nonclinical data, scientific literature, and regulatory documents

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • The position demands excellent interpersonal skills, decision-making, and ability to adapt to a fast-paced, dynamic, and complex regulatory and business environment
  • Strong team player who is solution oriented and proven track record of mobilizing cross-functional teams
  • Ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop and drive realistic plans, programs, and recommendations
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
  • This position requires a commitment to building out process, excellent organizational, and communication skills, a strong commitment to best practices, and the ability to work effectively as both a manager as well as cross-functional project team member
  • Demonstrated ability to translate strategy into action; excellent analytical skills, an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks
About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Patent Agent

Patent Agent

Job Description

Position Overview:

The candidate will help build Prothena’s intellectual property portfolio and contribute to its global patent strategy. Successful candidates should have demonstrable skills in evaluating and identifying new discoveries and leading the effort from initial filings on such discoveries to worldwide patent issuance. Candidates will have a strong understanding of U.S. and preferably foreign patent systems, including patent filing and prosecution processes, as well as innovation review, patent searching, and landscape assessments. This role reports to the company’s Lead IP Counsel.

Responsibilities:

  • Work closely with the research and development teams to identify new inventions and opportunities to create new inventions.
  • Prepare, draft, and prosecute patent applications, in conjunction with in-house and outside patent counsel, to advance Prothena’s intellectual property portfolio in alignment with company strategies.
  • Manage, in a cost-efficient way, outside counsel and patent portfolio related expenses.
  • Review proposed publications and presentations for intellectual property impact.
  • Contribute to development and evaluation of intellectual property strategy.
  • Conduct landscape and third-party portfolio assessments. 
  • Provide timely, practical, business-oriented intellectual property advice to internal clients.
  • Assist Prothena law group and management with additional intellectual property matters, as needed.
Qualifications

Education and Experience:

  • Patent Agent with 5+ years of experience.
  • Admission to practice before the USPTO and in good standing.
  • Advanced degree in a life science or related chemistry discipline is preferred but candidates with a bachelor’s degree and relevant experience will also be considered.
  • Experience in U.S. and foreign intellectual property law relating to biotechnology, in the commercial pharmaceutical industry, with a law firm or corporation.

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Excellent oral and written communication skills.
  • Strong analytical and research skills required.
  • Demonstrated success working in a fast-paced, fluid, high-performing, results-driven environment.
  • Ability to work independently and communicate legal issues and solutions clearly and concisely.

______________________________________________________________________________

More information about Prothena can be found at the Company’s website: www.prothena.com

About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Project Manager, Medical Affairs

Project Manager, Medical Affairs

Job Description

Position Overview:

The Medical Affairs Project Manager will provide project management support for a variety of the team’s Medical Affairs plan related activities. This includes coordination of Medical Affairs activities and review committees, management of the Medical Affairs budget, dashboard creation, and administration of shared electronic folders.

Responsibilities:

  • Manage the development and execution of medical affairs operational plans
  • Coordinate medical affairs team meetings and related communications
  • Planning and tracking of team deliverables
  • Coordinate Review Committee schedules, document upload, tracking and document retention
  • Provide HQ- and field-based support for congress related activities and ancillary meeting support related to thought leader engagement, advisory boards, and clinical trials
  • Create, maintain, and track the medical affairs budget and reconcile activities with the finance team
  • Coordinate use of medical affairs software systems for medical grants, publications, and field-based activities tracking
  • Work closely with legal and contracting teams to process contracts and related documents
  • Coordinate the creation, review, storage, and update of medical affairs SOPs and related documents
  • Create and maintain medical affairs dashboards to highlight medical affairs activities
  • Maintain medical affairs intranet page
  • Develop and maintain shared electronic folder structure (e.g., Box) to facilitate document retention information sharing among the medical team
  • Ad hoc activities related to the support of the team’s priorities and objectives
  • For the above priority activities, general expectations include:
    • Develop, maintain, and monitor project plans, project schedules, budgets, and expenditures
    • Organize and participate (e.g., captures meeting minutes, tracks action items, etc.) in project meetings
    • Proactively assess project risks and issues and provide solutions where applicable
    • Track project progress and provide project updates/summaries
    • Navigate internal processes and procedures, including compliance and finance, to ensure compliant execution of assigned projects
    • Ensure projects adhere to frameworks and all documentation is maintained appropriately for each project
Qualifications

Education and Experience:

  • Bachelor’s degree in scientific field or related discipline, Master’s degree preferred
  • Minimum 3 years of experience in Project Management, preferably within the biotech or pharmaceutical industry
  • Familiarity with Medical Affairs procedures and experience working with a Medical Affairs headquarters team strongly desired
  • Experience with managing review committees, including meeting preparation, meeting facilitation, and post meeting follow up
  • History of creating and managing departmental budgets
  • Experience with Medical Affairs software systems (e.g., Veeva) strongly preferred
  • Familiarity with creating dashboards to communicate and highlight departmental activities
  • Experience with setting up and managing shared folders (e.g., Box), including access rights

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve the company objectives in accord with the Prothena’s culture and values - courageous, imaginative, selfless, and joyful
  • Strong interpersonal, verbal, and written communication skills to work with medical and/or scientific teams
  • Ability to manage timelines, independently handle multiple projects and priorities simultaneously and function in a fast-paced environment
  • Quickly and comprehensively learns about new subject areas and environments
  • Self-motivated, flexible, resourceful, problem-solver with a passion for science
  • Strong analytical and problem-solving skills
  • Ability to work effectively in a cross-functional environment
  • Strong organizational skills and attention to detail
  • Up to 10% travel may be required
About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Research Associate

Research Associate

Job Description

Position Overview:

The Cell Biology Research group is seeking an independent and motivated Research Associate to join a research team focused on the discovery and development of novel therapeutics for neurodegenerative diseases. The qualified candidate must be scientifically driven and will participate in antibody discovery by aiding with the design, execution and reporting of preclinical cell biology studies.

Responsibilities:

  • Work within the Cell Biology group, as well as with additional preclinical teams, to investigate biological processes and to assess the mechanism of action of novel antibodies using a variety of techniques (flow cytometry, immunofluorescence, immunoblot, qPCR, etc.) with a willingness to learn additional techniques as needed
  • Establish and maintain cell lines and primary cell cultures
  • Perform well in handling multiple projects simultaneously
  • Use molecular biology, cell biology and imaging techniques to explore biology related to clinical, preclinical and discovery programs
  • Aid in the organization and supply of the Cell Biology labs
  • Communicate results in written summaries and internal oral presentations
Qualifications

Education and Experience:

  • The candidate must have a BS in biology or a related discipline and 2+ years of industry experience in cell biology or a related field
  • Previous experience with implementation of cell based in vitro assays including flow cytometry and basic molecular biology techniques such as ELISA and western blots
  • Previous experience with high content imaging and qPCR a plus
  • Competency with basic cell culture techniques
  • Isolation of primary neuronal cells a plus

Prothena follows strict COVID-19 related safety guidelines including physical distancing and use of personal protective equipment when on site.  Presence in the laboratory is required only when there are procedures or tasks to carry out, to minimize interactions between individuals.

Competencies and Attributes:

  • Demonstrated leadership ability to drive results that are needed to achieve the company objectives in accord with the Prothena core cultural values of courageous, creative, selfless, and joyful

_________________________________________________________________________

More information about Prothena can be found at the Company’s website: www.prothena.com

About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Scientist III

Scientist III

Job Description

Position Overview:

The antibody and assay discovery group is seeking an independent and motivated Scientist to join a research team focused on the discovery and development of novel therapeutics for neurodegenerative diseases. The qualified candidate should have expertise in target identification and validation of antibody therapeutics and an in- depth knowledge of the generation of rodent hybridomas to synthesize antibodies targeting diverse protein classes across multiple projects. The candidate will be expected to manage one to two research programs, manage and mentor junior scientists in antibody discovery and characterization, and drive projects forward with cross-functional teams.   

Responsibilities:

  • Manage a highly effective antibody discovery and characterization team that proposes novel immunization, fusion, and screening methods and develops strategies to generate antibodies with required properties by combining in house capabilities or contract technologies (B cell fusion, library expression)
  • Drive research programs forward through target identification and validation
  • Proficient in technology platforms needed to meet program antibody assessment requirements (e.g. FACS, ELISA, MSD, BIAcore, Forte Bio), and ability to guide project teams towards appropriate novel technologies or platforms as needed.
  • Work with the senior director and the program teams to propose strategies to meet multiple project goals
  • Execute on all stages of antibody generation to deliver diverse panels of antibodies meeting the required criteria
  • Strong focus, motivation, and commitment to hands-on lab work is required
  • Ability to effectively represent department across multiple discovery projects
  • Excellent written and oral skills are necessary
  • Accomplish goals under project team time lines
  • Experience in neuroscience drug discovery including neurodegeneration
Qualifications
  • PhD and a minimum of 5 years of direct research experience and a in depth understanding of hybridoma and antibody discovery
  • Ability to manage one to two research programs from target identification through candidate selection.
  • Ability to manage junior scientists in antibody discovery, antibody characterization and assay design
  • Knowledge of the therapeutic antibody field with good understanding of basic immunology
  • Molecular biology experience a plus

Competencies and Attributes

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Must be independent, creative, and self-motivated
  • Excellent communication skills a must
  • Proven management experience in a fast-paced environment
About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Senior Financial Analyst

Senior Financial Analyst

Job Description

Position Overview:

The Senior Financial Analyst provides support for all financial aspects related to month end close, reporting results, budgeting/forecasting, modeling, and analytical and strategic support.  Other duties include, but are not limited to, supporting cross functional project teams and individual functions with monitoring and analysis of end-to-end spending for external expenses, and reviewing contracts and vendor payments. 

Responsibilities:

  • Work collaboratively with functional areas to ensure that the data necessary to accurately monitor and report on spending, accruals, budgets, and forecasts is collected, maintained, and analyzed in a timely manner. 
  • Work closely with Accounting on the month end and quarter end close processes, including accruals, reconciliations, etc.
  • Maintain organized set of detailed records and files to document and support financial transactions.
  • Perform analysis of processes related to spending and accruals in accordance with GAAP / SOX compliance.
  • Collaborate with finance management and business partners to develop annual budget, forecast, financial reviews for actual versus budget/forecast, and ad-hoc analysis
  • Establish and maintain relationships with key internal and external stakeholders and help troubleshoot finance-related issues.
  • Monitor end-to-end spending from expenditure purchase order request to vendor invoicing.
  • Review vendor contacts and payment terms as needed
  • Perform other duties as assigned or required.
Qualifications

Education and/or Experience:

  • BA/BS in business, accounting, or related field
  • A minimum of 3 – 5 years’ experience in accounting and finance
  • Experience in Biotech/Pharmaceutical industry preferred
  • Experience in business partnering role, including understanding of functional area roles, responsibilities, and interdependencies of the drug development process through commercialization
  • Understanding of accrual accounting as it relates to drug development / life sciences
  • Excellent interpersonal skills and the ability to work effectively with multiple functional areas in a collaborative, team environment.
  • ERP experience preferred

Competencies and Attributes:

  • Demonstrated leadership ability to drive results that are needed to achieve the company objectives in accord with the Prothena core cultural values of courageous, imaginative, joyful, and selfless
  • Demonstrated ability and commitment to meet tight deadlines and multitasking
  • Results oriented with strong accounting, financial skills
  • Strong analytical skills
  • Strong organization, time management skills and attention to detail
  • Excellent verbal and written communication skills, demonstrating the ability to communicate effectively with employees of different levels
  • Excellent team work and collaboration skills
About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Sr. Clinical Scientist

Sr. Clinical Scientist

Job Description

Prothena’s Clinical Development organization is responsible for the design, execution, and delivery of results from clinical trials from Phase I to Phase III for all pipeline molecules throughout the company.  

The Senior Clinical Scientist is the most senior clinical scientist within the company and is a key participant and/or lead in the creating of the clinical development strategy and plan for a molecule(s).  Senior Clinical Scientists support Medical Directors with clinical trial documentation and acts as the primary internal and external point of contact for the clinical development organization for the molecule(s).  Senior Clinical Scientist are expected to perform their responsibilities with considerable independence, and will have regular interactions with clinical trial sites, vendors, key opinion leaders, and health authorities as needed. 

Responsibilities:

  • Lead representative for Clinical Science on the molecule(s) global product team, study management team, and other molecule sub-teams as needed.
  • Takes the lead in or is the key participant in creating the clinical development strategy of a molecule(s).
  • Serves as the primary point of contact internally for any clinical questions about the molecule(s).
  • Is the primary responsible person for the content and completion of clinical trial documentation, e.g. protocol and amendments, investigator brochures (IB), informed consent form (ICF), case report forms (CRFs).
  • Is the primary responsible person for the clinical portion of health authority meeting packages, clinical study reports (CSR), safety narratives, newsletters/communications to study sites, DSURs, BLA/MAA/NDA.
  • In collaboration with others on the study management team, ensures the Trial Master File (TMF) remains up to date as well as compliance with the overall study data quality plan.
  • Responsible for the conduct of ongoing medical/safety data reviews and medical monitoring.
  • Serves as the primary point of contact for vendors and trial sites for questions regarding the clinical protocol.
  • Key participant in study start-up, study data base lock, data cleaning, study results interpretation, and study close-out.
  • Will participate and present, as needed, during interactions with key opinion leaders (e.g., on Steering Committees, DSMBs, and Advisory Boards), investigator meetings, health authority meetings, study site visits, site training, and health authority inspections as the lead clinical science representative.
  • May serve as the clinical science representative for pre-clinical molecules and partnering due diligence.
  • May participate in developing and writing scientific/clinical abstracts, posters, conference presentations, and manuscripts.
  • May manage one or more direct reports, typically other Clinical Scientists.
  • Keeps current and knowledgeable about both internal and external developments (e.g. key scientific publications/presentations, current clinical trial design considerations, disease specific clinical trial outcomes, regulatory guidances) that are relevant to the molecule(s) and disease area.
Qualifications

Education and Experience:

  • Bachelor’s Degree required, preferably in the life sciences
  • Advanced degree preferred (e.g., PhD, PharmD, MSN)
  • Minimum of 6 years of clinical trial experience in the pharma/biotech industry
  • Strong experience in developing and authoring clinical development plans and study protocols
  • Proficient in medical terminology and medical writing skills.
  • Preference for experience across all stages of clinical development from Phase I to Phase III
  • Preference for experience in neuroscience and/or hematology/oncology clinical development
  • Prior experience filing BLAs, MMAs, or NDAs is a plus
  • Deep knowledge of GCP, ICH, and FDA guidelines
  • Ability to travel (<35%)

Competencies and Attributes:

  • Outstanding attention to detail
  • Excellent written and verbal communication skills
  • Demonstration of strong teamwork
  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.

Sr. Director/VP, Product Team Leader

Sr. Director/VP, Product Team Leader

Job Description

Position Overview:

Reporting to the Senior Vice President of Portfolio & Alliance Management, the Product Team Leader (PTL) will be responsible for leading multifunctional team(s) in driving the formulation and execution of the strategic plans for the global development and commercialization of products. 

The PTL is ultimately accountable to the Prothena Portfolio Review Committee (PRC) for an aligned product vision, strategy and all related activities and deliverables for assigned products, including pre-clinical, clinical and CMC development, regulatory submission and approval, and commercial planning and launch, and ongoing life-cycle management.  The PTL role is highly visible in the organization and offers an opportunity to make significant contributions towards Prothena’s goals of delivering innovative therapies for patients.

Responsibilities:

  • Product Oversight & Life-cycle Optimization - Oversee all aspects of research, development, commercialization, and manufacturing of assigned product(s). Provide recommendations to the PRC and executive team to maximize the value of assigned product(s), within the context of the broader portfolio, over the entire lifecycle of the product.
  • Team Leadership - Provide strategic leadership to the Global Product Team (GPT), a multifunctional team comprising of preclinical and clinical development, technical operations, regulatory, medical affairs, and marketing/commercial.
  • Strategic Product Planning - Develop a product vision, and lead the GPT in the preparation/update of multi-year, Strategic Product Plans which integrate and align research, development, manufacturing, and commercial objectives.
  • Organizational Influence & Mobilization - Ensure strategic and tactical plans and timelines are developed, aligned, approved, and implemented cross-functionally and globally. Secure necessary resources for the GPT and sub-teams, including an approved budget, and assure that the resources are utilized appropriately. 
  • Strategic Opportunity/Risk Management - Proactively identify and manage program risks and opportunities, including updating and/or escalation to PRC and/or executive team for information or action, when appropriate.
  • Organizational Communication & Alignment - Appropriately communicate status and/or updates/changes to the program to PRC, functional stakeholders, and executive team. Ensure proper expert peer review of plans throughout the organization.
  • Collaboration Leadership – Drive relevant partnering and licensing activities in relation to assigned projects/products.
Qualifications

Education and Experience:

  • 10+ years progressive biopharma development related business experience, the majority of which in a leadership capacity.
  • Minimum B.S./B.A. degree in Business or Life Science. Graduate degree (Science or MBA) and/or equivalent experience and education in strategic leadership and business preferred.
  • Demonstrated experience developing and executing biopharma product life-cycle strategies and tactics.
  • Proven ability to lead and mobilize multidisciplinary, matrix teams (10+ employees) on multifaceted drug development programs from pre-clinical development through commercialization.
  • Proven experience as a successful decisive leader in a strategic, multifunctional environment.
  • Demonstrated ability to work successfully in a nimble, fast-paced, matrixed environment.
  • Demonstrated ability to manage and influence up and across an organization with regards to product strategy, technical data and program resources
  • Market-relevant experience in neuroscience a plus

Competencies and Attributes:

  • Ability to build relationships, influence, and align executive stakeholders across research, development, commercial, and manufacturing.
  • Ability to thrive in a matrixed, entrepreneurial small company environment and manage across multiple time zones.
  • Exceptional biopharma business, scientific, and financial acumen with strong decision analysis skills.
  • Excellent written and verbal communication skills, as well as strong presentation skills.
  • Confident, strategically innovative, data-driven with an ability to “brainstorm” in a collaborative and collegial manner.
  • Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful

_________________________________________________________________________

More information about Prothena can be found at the Company’s website: www.prothena.com.

About Us

Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.

Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).

Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.