Open Positions

Associate Director, CMC Project Manager

Associate Director, CMC Project Manager

Job Description

Position Overview:

Reporting to the Senior Vice President of Technical Operations, the Associate Director, CMC Project Manager will be responsible for management and delivery of all aspects of the CMC development programs.

This will involve managing the development of assets from Research transition to commercialization, managing external vendors and internal resources to achieve the program objectives and timelines. In particular, the incumbent will be responsible for effective oversight from a financial and reporting perspective for all programs, supporting the CMC Program Leads and Supply Chain Management.

Responsibilities:

  • Lead various scheduled and ad hoc CMC or CMC sub-team meetings
  • Assist in the implementation of project related tasks
  • Utilize project management tools and best practices to support CMC activities
  • Document, track and communicate progress against CMC timelines, milestones and budgets
  • Represent the CMC work in all integrated Prothena project teams as required
  • Assure and track all budget, POs, and payment to CMOs
Qualifications

Education and Experience:

  • B.S./M.S. degree or higher, preferably in Life/ Physical Sciences.
  • MBA and/or Project Management Qualification (PMI) a plus
  • 10+ years’ experience in a Manufacturing/ Development environment in the biopharmaceutical industry
  • CMC Program management experience, with thorough knowledge of biologics and preferably small molecule platforms
  • Knowledge and use of Enterprise software and management of budgets
  • Proficient with Microsoft Office (e.g. Word, PowerPoint, Excel) and Microsoft Project.

 

Competencies and Attributes:

  • Excellent written and verbal communication; strong presentation skills
  • Ability to deal with incomplete information or ambiguity in a composed manner
  • Self-organized with strong critical thinking and analytical skills
  • Ability to develop strong relationships with external CMOs and internal stakeholders
  • 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.

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, Clinical Trial Management

Director, Clinical Trial Management

Job Description

Position Overview:

The Director, Clinical Trial Management will lead the execution of a clinical program or multiple clinical studies, ensuring they are conducted on time, within budget, and of appropriate quality. This individual will have line management responsibilities.

Responsibilities:

  • Maintains accountability for the successful delivery of clinical program or multiple clinical studies from study planning to close-out
  • Manages program / study finances. Leads negotiation of vendor contracts, ensuring clarity in contracts and budgets, and oversees vendor performance to contract and agreed budget.
  • Oversees or develops integrated study timelines, ensuring close coordination between the Prothena study team and external parties
  • Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs
  • Ensures that risks to timelines, budgets, or quality are identified proactively, communicated effectively, and mitigated appropriately.
  • Manages Clinical Trial Leads to deliver on operational aspects of clinical trials, including site and vendor selection and oversight, study project management, and Trial Master File management
  • Oversees the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and leads team to conduct trial activities in accordance with agreed plans
  • Maintains strong relationships with CROs, vendors, and investigative sites
  • Works in partnership with key internal functions including, but not limited to Finance, Legal, Regulatory, Biometrics, Clinical Development, and Medical Affairs
  • Participates in SOP / process development and other department initiatives, as needed
Qualifications

Education and/or Experience

  • Bachelor’s degree in scientific discipline required; master’s degree or higher preferred
  • At least 10 years’ experience in clinical operations in biotech / pharma companies and/or CRO
  • Strong experience managing Phase 1-3 multinational clinical trials, including successful management of cross-functional teams
  • Solid experience with vendor and site selection, contracts and budgeting, and vendor and site oversight
  • Demonstrated expertise in Good Clinical Practice and experience with sponsor regulatory inspection(s)
  • Working knowledge of translational science, regulatory operations, biometrics, pharmacovigilance, and medical monitoring
  • Experience managing direct reports, including hiring, performance management, and development
  • Willingness to be an individual contributor or hands-on team leader, according to project demands
  • Experience managing neuroscience, oncology, or rare disease clinical trials strongly preferred

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 written and verbal communication skills
  • Solid critical thinking skills
  • Strong people leadership 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.

Director, Clinical Trial Management (EU)

Director, Clinical Trial Management (EU)

Job Description

Position Overview:

The Director, Clinical Trial Management will lead the execution of a clinical program or multiple clinical studies, ensuring they are conducted on time, within budget, and of appropriate quality. This individual will have line management responsibilities.

Responsibilities:

  • Maintains accountability for the successful delivery of clinical program or multiple clinical studies from study planning to close-out
  • Manages program / study finances. Leads negotiation of vendor contracts, ensuring clarity in contracts and budgets, and oversees vendor performance to contract and agreed budget.
  • Oversees or develops integrated study timelines, ensuring close coordination between the Prothena study team and external parties
  • Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs
  • Ensures that risks to timelines, budgets, or quality are identified proactively, communicated effectively, and mitigated appropriately.
  • Manages Clinical Trial Leads to deliver on operational aspects of clinical trials, including site and vendor selection and oversight, study project management, and Trial Master File management
  • Oversees the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and leads team to conduct trial activities in accordance with agreed plans
  • Maintains strong relationships with CROs, vendors, and investigative sites
  • Works in partnership with key internal functions including, but not limited to Finance, Legal, Regulatory, Biometrics, Clinical Development, and Medical Affairs
  • Participates in SOP / process development and other department initiatives, as needed
Qualifications

Education and/or Experience

  • Bachelor’s degree in scientific discipline required; master’s degree or higher preferred
  • At least 10 years’ experience in clinical operations in biotech / pharma companies and/or CRO
  • Strong experience managing Phase 1-3 multinational clinical trials, including successful management of cross-functional teams
  • Solid experience with vendor and site selection, contracts and budgeting, and vendor and site oversight
  • Demonstrated expertise in Good Clinical Practice and experience with sponsor regulatory inspection(s)
  • Working knowledge of translational science, regulatory operations, biometrics, pharmacovigilance, and medical monitoring
  • Experience managing direct reports, including hiring, performance management, and development
  • Willingness to be an individual contributor or hands-on team leader, according to project demands
  • Experience managing neuroscience, oncology, or rare disease clinical trials strongly preferred

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 written and verbal communication skills
  • Solid critical thinking skills
  • Strong people leadership 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.

Director/Sr. Director, Biostatistics

Director/Sr. Director, Biostatistics

Job Description

Position Overview:

The Director/Senior Director, Biostatistics will lead Biostatistics support for one or multiple therapeutic areas to ensure that Company Research and Development projects are optimally strategized, correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products. Accountable directly or through subordinates for the statistical strategy and design in all projects in their therapeutic area(s) for full compound development and product life cycle. Provides input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy.  Represent Biostatistics in meetings with cross-functional project teams and regulatory agencies. Additional essential functions of this position include: ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training; leading in the development and adaptation of new statistical methodology in support of drug research and development as required; keeping current with regulatory guidance and requirements in the global environment; hiring, mentoring and managing employees to maintain a competent and qualified staff; selecting and hiring qualified and cost-effective CRO's to supplement internal resources; and monitoring the performance of CRO's to ensure high quality products and services.

Responsibilities:

  • Plans, organizes, and directs the activities of Biostatistics to support one or more therapeutic areas to ensure clinical programs are optimally designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products.
  • Participates in establishing and maintaining policies, standards, and procedures for global Biostatistics.
  • Leads in development and adaptation of new statistical methodology in support of research and development, keeping current with regulatory guidance and requirements in the global environment.
  • Provides statistical consultations and strategic inputs in terms of drug development for cross-functional teams within the company.
  • Assists in the development of study protocols, provides sample size estimates and power calculations for complex study designs, and oversees generation of randomization schedule for complex randomization schemes.
  • Hires, mentors and manages employees to maintain a competent and qualified staff.
  • Selects and hires qualified and cost-effective CRO's to supplement internal resources; and monitors the performance of CRO's to ensure high quality products and services. Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables.
  • Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration.
  • Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals.
  • Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
  • Collaborate with members of project teams to establish project timelines and to develop and implement protocols.
  • Work closely with data management, clinical operations, programming, and other biostatisticians to develop and validate study-specific data capture systems.
  • Develop statistical analysis plans (SAPs) to meet regulatory standards, coordinate and perform data analysis and validation as necessary, and provide data interpretation.         
  • Produces table, figure, and listing templates for reporting of study results and data.
  • Coordinates data and table review activities among the project team members.
  • Reviews study protocols, CRFs, Data Validation Specifications (DVS), and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data.
  • Writes specifications for datasets, tables, figures, listings, and consistency checks for both efficacy and safety analyses; performs validation of key statistical results.
  • Analyzes clinical trial data producing accurate results representing the outcome of the trial. Validates statistical output.
  • Develops templates for ISS and ISE statistical tables for regulatory submission in conjunction with clinical and provides specs and supervision for production of ISS and ISE tables.
  • Reviews ISS and ISE reports towards regulatory submission.
  • Performs statistical analysis for publication.
  • Provides input in preparation of study reports, with particular emphasis on the statistical methods section, and works closely with Medical Writing in study report preparation.
  • Responds to questions from the FDA and other regulatory authorities on statistical issues.  Attend regulatory meetings to support and defend clinical programs.
  • Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data.
  • Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc.
  • Communicates with Project Managers regarding resourcing to assure the appropriate staff is assigned to each study.
  • Train and mentor new statisticians.
  • Other duties as assigned.
Qualifications

Education and/or Experience:

  • PhD in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with a minimum of 10 years of relevant work experience OR a Master’s degree in Statistics or Biostatistics or a related health science field, and a minimum of 12 years of biostatistical experience in the clinical trials or health research environment.
  • Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics
  • Familiarity with pharmacokinetic/pharmacodynamic data, a plus
  • Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts) a plus
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
  • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.
  • eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA
  • Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff.
  • Experience managing clinical research vendor (CROs, Central Labs, etc.)

Required Knowledge & Abilities:

  • Knowledge of CDISC requirements for SDTM and ADaM
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Requires understanding of the company’s products, the competition and the pharmaceutical industry in general
  • Maintains current awareness of new drug developments in the business.

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 written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.
  • Exceptional interpersonal skills and problem solving capabilities.
  • Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.

___________________________________________________________________________________

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/Sr. Manager, Business Development

Manager/Sr. Manager, Business Development

Job Description

Position Overview:

Prothena is seeking a Manager/Senior Manager, Business Development to play a key role in the execution of our business strategy in neuroscience and expanding our growth and value creation opportunities through partnerships, acquisitions and other collaborations. The successful candidate will have responsibility for identifying, monitoring and evaluating external growth opportunities for Prothena and, where appropriate, supporting and executing transactions. This critical and highly visible role will develop a deep understanding of the competitive landscape across neuroscience and will also build strong relationships with cross-functional leaders and key stakeholders.

Responsibilities:

  • Partner with COO and senior management on the execution of Prothena’s business development strategy through value creation opportunities
  • With BD colleagues, actively network internally and externally to identify, track and evaluate potential business development opportunities; manage internal BD databases
  • Support and coordinate diligence evaluations with cross-functional teams to ensure a detailed understanding of the potential and the risks of each opportunity
  • Prepare effective presentations summarizing diligence evaluations based on scientific merit, patient impact and financial metrics to senior management to enable decision making
  • Develop and maintain a deep understanding of the competitive landscape across neuroscience and other areas of strategic interest; monitor pipelines and deal activities across multiple sources to maintain awareness and identify potential strategic opportunities for Prothena
  • Represent Prothena at medical and partnering conferences relevant to Prothena strategic priorities; advance relationships with members of the industry and academic communities to support business development objectives, such as KOLs, VCs and industry leaders
Qualifications

Education and/or Experience:

  • Bachelor’s degree and 2 - 5 years of biopharma industry experience in business development, banking, consulting or related field required
  • Scientific background preferred with working knowledge of drug discovery, development and commercialization processes
  • Demonstrated experience supporting and participating in a wide range of business development activities and/or strategic portfolio planning projects
  • Strong business and financial acumen with demonstrated ability to analyze and assess new business development opportunities; comfortable with financial modeling
  • Experience managing multiple projects simultaneously with high attention to detail

Competencies and Attributes:

  • Ability to work both independently and collaboratively with cross-functional partners in an entrepreneurial, dynamic, fast-paced environment
  • Comfort interacting with the highest levels of senior management both within Prothena and at other organizations
  • Excellent communication and presentation skills; the ability to create and present clear and convincing presentations at varying levels of detail depending on audience is important to this role
  • Has a learning mindset and a curious disposition, motivated to produce high quality work
  • Resourceful; technologically savvy and can think creatively about how to utilize technology to gather and distribute information effectively
  • 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.

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.

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.

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/Vice President, Global Regulatory Affairs

Sr. Director/Vice President, Global Regulatory Affairs

Job Description

Position Overview:

The Sr. Director/Vice President, Global Regulatory Affairs, reporting to the Chief Regulatory Officer, will provide strategic and operational regulatory leadership to advance the development of innovative therapeutic products. The successful candidate will oversee regulatory filings and communications for investigational products, which may include monoclonal antibodies, vaccines and/or small molecules.

Responsibilities:

  • Provide or oversee regulatory leadership on project team(s), collaborating with senior leaders and cross-functional team members on development and implementation of regulatory strategies to advance the progress of investigational products consistent with overall program strategy and regulatory requirements; anticipate and mitigate strategic risks
  • Execute regulatory strategies and perform critical data assessments to enable timely and effective preparation, review, and submission of key regulatory filings
  • Recruit, mentor, and direct a team responsible for regulatory submissions such as original INDs/CTAs/BLAs/MAAs, meeting requests and briefing documents, responses to Agency requests, and maintenance submissions in conjunction with Regulatory Operations and Regulatory Writing
  • Establish and maintain effective ongoing communications with FDA and other Regulatory Agencies, as applicable for development programs
  • Support the initiation, conduct and completion of clinical trials, including the review of clinical protocols and study reports, in collaboration with other functions such as Clinical Development, Clinical Operations, Global Safety & Pharmacovigilance, Data Management and Biostatistics
  • Maintain and expand working knowledge of applicable regulatory requirements and precedents to inform both regulatory strategies and requirements for development programs, providing updates to project teams and/or functional areas as needed
  • Guide selection and ongoing management of regulatory contractors and CROs to ensure timely and effective regulatory communications and compliance; manage members of regulatory team
  • Additional responsibilities include preparation and/or review of SOPs, budget and other activities, as needed
Qualifications

Education and Experience:

  • Advanced or Bachelors degree in a scientific discipline; life sciences preferred
  • >15 years of regulatory experience, preferably with at least 10 years in a pharmaceutical or biotechnology company focused on novel therapies; experience with rare and neurodegenerative diseases preferred
  • Ability to manage all aspects of regulatory activities from pre-IND through late-stage clinical development, including oversight of Regulatory Operations and CMC Regulatory; product registration/commercial experience required
  • Demonstrated hands on experience leading preparation, submission, and maintenance of key regulatory filings, in collaboration with project teams
  • Prior FDA regulatory liaison and global experience required
  • Prior experience managing a team required
  • Track record of effective collaboration on project teams, and across multiple organizational levels and functions

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accordance with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Ability to build and maintain effective internal and external relationships, including cross-functional teams, regulatory agencies and contract research organizations
  • Excellent strategic, planning and organizational skills, including the ability to support and prioritize multiple projects, as needed
  • Demonstrated competence in understanding and effectively applying current regulatory requirements in an emerging regulatory landscape
  • Must display strong analytical and problem-solving abilities
  • Excellent written and verbal communication skills essential
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) Medical Science Liaison - EU

(Sr) Medical Science Liaison - EU

Job Description

Position Overview:

The (Sr) MSL will be a field-based representative of the medical affairs organization at Prothena primarily for Europe (and to a lesser extent other parts of the world outside the US). The MSL/Sr. MSL will serve to develop and maintain working relationships with external collaborators and key opinion leaders within disease areas relevant to the company. The (Sr) MSL will be Prothena’s scientific regional expert.

Responsibilities:

  • Develop and maintain relationships with key opinion leaders, other external experts, and principal investigators
  • Identify key national and regional thought leaders and any other external expert of interest (i.e. patient advocacy groups, digital opinion leaders, new investigators, etc.)
  • Support clinical trial related activities, related to patient identification, recruitment and investigator education
  • Help coordinate medical education to external stakeholders (patient advocacy groups, investigators and other experts within Company’s disease areas)
  • Participate in the collection and exchange of scientific/technical information important to Prothena development efforts
  • Ensure all materials and activities reflect the highest standard of quality (i.e., material accurately referenced, correctly interpreted and communicated appropriately)
  • Identify, coordinate, evaluate and monitor investigator-sponsored trials intended to support the clinical and scientific strategy of Prothena products
  • Help develop and manage to timelines publication plans of investigator-sponsored studies
  • Represent Prothena at major meetings and conferences relevant to research and development efforts, including hematology, cardiology, nephrology and neurology disease states
  • Maintain clinical and technical expertise in the therapeutic area through review of the scientific literature and attendance at key scientific meetings
  • Assist in the development of, and participate in, regional advisory boards and medical education programs
  • Coordinate with Prothena HEOR team on country-specific payer-related needs and education
  • Collaborate with and support in-office staff, e.g., publications, resource development, training, internal events, etc.
  • Other duties as assigned
Qualifications

Education and Experience:

  • Advanced scientific or clinical degree (PhD, PharmD, or MD preferred) with a minimum of 3-5 years’ experience in industry (i.e., biotech/pharmaceutical/medical device company, Contract Research Organization)
  • 1-3 years’ experience as an MSL required
  • Rare Disease and hematology experience preferred
  • Cardiology and/or neurology experience a plus
  • Fluent in two or more European languages

 

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
  • Ability to manage timelines, multiple priorities under time constraints
  • Experience with clinical research, publication activities, congress/conference/academy presentations
  • Aptitude to develop technical expertise in new therapeutic areas
  • Strong analytical and problem solving skills
  • Ability to work effectively in a cross-functional environment
  • Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders.
  • Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
  • Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building
  • Field based position. Up to 80% travel 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.

(Sr) Medical Science Liaison - US Field (East)

(Sr) Medical Science Liaison - US Field (East)

Job Description

Position Overview:

The (Sr) MSL will be a field-based representative of the medical affairs organization at Prothena, who will serve to develop and maintain working relationships with external collaborators and key opinion leaders within disease areas relevant to the company. The (Sr) MSL will be Prothena’s scientific regional expert.

Responsibilities:

  • Develop and maintain relationships with key opinion leaders, other external experts, and principal investigators
  • Identify key national and regional thought leaders and any other external expert of interest (i.e. patient advocacy groups, digital opinion leaders, new investigators, etc.)
  • Support clinical trial related activities, related to patient identification, recruitment and investigator education
  • Help coordinate medical education to external stakeholders (patient advocacy groups, investigators and other experts within Company’s disease areas)
  • Participate in the collection and exchange of scientific/technical information important to Prothena development efforts
  • Ensure all materials and activities reflect the highest standard of quality (i.e., material accurately referenced, correctly interpreted and communicated appropriately)
  • Identify, coordinate, evaluate and monitor investigator-sponsored trials intended to support the clinical and scientific strategy of Prothena products
  • Help develop and manage to timelines publication plans of investigator-sponsored studies
  • Represent Prothena at major meetings and conferences relevant to research and development efforts, including hematology, cardiology, nephrology and neurology disease states
  • Maintain clinical and technical expertise in the therapeutic area through review of the scientific literature and attendance at key scientific meetings
  • Assist in the development of, and participate in, regional advisory boards and medical education programs
  • Collaborate with and support in-office staff, e.g., publications, resource development, training, internal events, etc.
  • Other duties as assigned
Qualifications

Education and Experience:

  • Advanced scientific or clinical degree (PhD, PharmD, or MD preferred) with a minimum of 3-5 years’ experience in industry (i.e., biotech/pharmaceutical/medical device company, Contract Research Organization)
  • 1-3 years’ experience as an MSL required
  • Rare Disease and hematology experience preferred
  • Cardiology and/or neurology experience a plus

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
  • Ability to manage timelines, multiple priorities under time constraints
  • Experience with clinical research, publication activities, congress/conference/academy presentations
  • Aptitude to develop technical expertise in new therapeutic areas
  • Strong analytical and problem solving skills
  • Ability to work effectively in a cross-functional environment
  • Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders.
  • Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
  • Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building
  • Field based position. Up to 80% travel required

_____________________________________________________________________________________

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.

(Sr) Medical Science Liaison - US Field (West)

(Sr) Medical Science Liaison - US Field (West)

Job Description

Position Overview:

The (Sr) MSL will be a field-based representative of the medical affairs organization at Prothena, who will serve to develop and maintain working relationships with external collaborators and key opinion leaders within disease areas relevant to the company. The (Sr) MSL will be Prothena’s scientific regional expert.

Responsibilities:

  • Develop and maintain relationships with key opinion leaders, other external experts, and principal investigators
  • Identify key national and regional thought leaders and any other external expert of interest (i.e. patient advocacy groups, digital opinion leaders, new investigators, etc.)
  • Support clinical trial related activities, related to patient identification, recruitment and investigator education
  • Help coordinate medical education to external stakeholders (patient advocacy groups, investigators and other experts within Company’s disease areas)
  • Participate in the collection and exchange of scientific/technical information important to Prothena development efforts
  • Ensure all materials and activities reflect the highest standard of quality (i.e., material accurately referenced, correctly interpreted and communicated appropriately)
  • Identify, coordinate, evaluate and monitor investigator-sponsored trials intended to support the clinical and scientific strategy of Prothena products
  • Help develop and manage to timelines publication plans of investigator-sponsored studies
  • Represent Prothena at major meetings and conferences relevant to research and development efforts, including hematology, cardiology, nephrology and neurology disease states
  • Maintain clinical and technical expertise in the therapeutic area through review of the scientific literature and attendance at key scientific meetings
  • Assist in the development of, and participate in, regional advisory boards and medical education programs
  • Collaborate with and support in-office staff, e.g., publications, resource development, training, internal events, etc.
  • Other duties as assigned
Qualifications

Education and Experience:

  • Advanced scientific or clinical degree (PhD, PharmD, or MD preferred) with a minimum of 3-5 years’ experience in industry (i.e., biotech/pharmaceutical/medical device company, Contract Research Organization)
  • 1-3 years’ experience as an MSL required
  • Rare Disease and hematology experience preferred
  • Cardiology and/or neurology experience a plus

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
  • Ability to manage timelines, multiple priorities under time constraints
  • Experience with clinical research, publication activities, congress/conference/academy presentations
  • Aptitude to develop technical expertise in new therapeutic areas
  • Strong analytical and problem solving skills
  • Ability to work effectively in a cross-functional environment
  • Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders.
  • Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
  • Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building.
  • Field based position. Up to 80% travel 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.

Sr. Scientist, Protein Sciences

Sr. Scientist, Protein Sciences

Job Description

Position Overview:

We are seeking an experienced and exceptional leader for our Protein Sciences group. This group is embedded within the Research department and is responsible for providing protein biochemistry expertise (including protein production, analytical characterization, and biochemistry support) to several preclinical and clinical programs. The Protein Sciences group actively collaborates with other Research scientists and functions to advance the discovery portfolio, and works cross-functionally to support all preclinical and clinical programs. The leader of this group must be collaborative and team-oriented and enjoy the fast-paced and hands-on research environment of a science- and patient-centric company.

Responsibilities:

  • Lead the Protein Science group to:
    • generate, screen and characterize biotherapeutic candidates and other recombinant proteins
    • support Discovery Biology programs, which includes applying biochemical techniques to isolate proteins and complexes from natural and recombinant sources, study protein-protein interactions, and characterize biophysical properties of proteins
    • identify, assess and implement new technologies to enhance our technical capability and working efficiency
  • Lead and mentor lab members within the Protein Sciences group; enable Discovery and Development programs through strategic application of group resources
  • Contribute to the identification and validation of novel targets, and contribute to the design, development and testing of novel protein modalities
  • Provide conceptual input and technical expertise in cross-functional project meetings
Qualifications

Education and experience:

  • Ph.D. in Biochemistry, Cell Biology or related field with at least 5 years industry experience, OR B.S./M.S. with 10-15 years industry experience
  • Previous experience as a direct supervisor
  • Previous experience in screening and characterizing biotherapeutic candidates
  • Demonstrated expertise in the design, execution and analysis of experiments to address scientific questions regarding protein structure/function relationships
  • Experimental background and understanding of techniques used for protein purification (from recombinant and natural sources) and characterization (functional and biophysical)

Competencies and Attributes:

  • Ability to foresee and solve problems, mitigate risks, prioritize and meet deadlines
  • Demonstrated ability to create and build positive cross-functional relationships
  • Professional attitude with strong decision-making skills and ability to work calmly in a high intensity and dynamic environment
  • Oral and written communication proficiency paired with excellent organizational aptitude
  • 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.