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:

  • 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.

Scientist, Bioanalytical Assays

Scientist, Bioanalytical Assays

Job Description

Position Overview:

The ideal candidate will bring his/her experience with assay design, development, and implementation and become part of a team supporting the development of therapeutic antibodies.  The individual will support the group with both management and hands-on efforts necessary to support the development of bioanalytical assays for both pre-clinical and clinical programs and will be in the lab up to 70% of the time. 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:

  • Hands on experience in designing fit for purpose biomarker assays
  • Hands on experience in designing, developing and troubleshooting methods for pharmacokinetic, anti-drug antibodies (ADA and Cell based Nab assays) biomarkers and potency assay that are suitable for use in GxP and clinical studies
  • Experience working in multiple matrices including, serum, plasma, CSF and tissue extracts.
  • Initiate and Manage relationships with Contract Research Organizations (CROs) for method transfer, validation, sample analysis and report generation
  • Experience in and knowledge of industry guidance for the development and validation of pK, immunogenicity immunoassays and bioassays, biomarkers and/or potency assays
  • Prepare reports, regulatory documents (e.g. INDs and BLAs)
  • Lead, develop, and mentor a high performing bioanalytical team.
Qualifications

Education and Experience:

  • Minimum PhD or MS with 5+ years of applicable experience or BA with 10+ years of applicable experience
  • Proven track record of scientific, managerial, and collaboration work
  • Extensive hands-on experience with the design, development, optimization, qualification and validation of novel immunoassays and bioassays across multiple platforms and technologies (eg, ELISA, MSD, AlphaScreen, flow cytometry; cell based, etc.)
  • Demonstrated ability to identify, negotiate, and oversee outsourced services with vendors.
  • Experience with financial budget planning and tracking.
  • Proven experience working in a bioanalytical laboratory environment is essential
  • Maintain current knowledge of the field and area(s) of scientific expertise and development
  • Data review, approval, analysis, graphing, reporting and presentation to internal and external 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
  • 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
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, Clinical Quality Assurance

Sr. Director, Clinical Quality Assurance

Job Description

The Senior Director, Clinical Quality Assurance will provide strategic and operational leadership to ensure that our clinical trials follow Good Clinical Practices. The successful candidate will oversee GCP compliance and play a key role in advancing the development of innovative therapeutic products.   

Responsibilities:

  • Responsible to oversee GCP compliance for Prothena’s clinical studies. Recruit, mentor, and direct internal and external QA resources performing GCP activities.
  • Provide or oversee GCP leadership on Study Management Teams, collaborating with senior leaders and cross-functional team members in supporting startup, conduct and completion of clinical trials; anticipate and mitigate risks
  • Lead and direct audit activities of studies and clinical trial vendors, contributing in the selection of CROs
  • Develop and lead GCP training and collaborate Clinical Operations leadership on study site training
  • Lead GCP inspection readiness activities, host audits and inspections, and support regulatory inspections of investigational sites or CROs
  • Maintain and expand working knowledge of applicable FDA, EMA applicable regulations, directives and guidelines and determine any impact on clinical compliance and provide guidance functions on GCP and/or quality assurance issues
  • Establish and maintain GCP SOPs and procedures in collaboration with other functions such as Clinical Development, Clinical Operations, Global Safety & Pharmacovigilance, Data Management and Biostatistics
Qualifications

Education and Experience:

  • Advanced or Bachelor degree in a scientific discipline; life sciences preferred
  • ≥10 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years of experience in clinical quality assurance
  • Strong and demonstrated understanding of applicable regulatory requirements and ICH guidelines
  • Experience with FDA and global regulatory inspections and US and Global Clinical Trials
  • Prior experience managing a team required
  • Track record of effective collaboration on project teams, and across multiple organizational levels and functions
  • Certified Quality Auditor (CQA) certification a plus

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – courageous, imaginative, selfless, and joyful
  • Ability to build and maintain effective internal and external relationships, including cross-functional teams, and contract research organizations
  • Excellent strategic, planning, and organizational skills, including the ability to support and prioritize multiple projects, as needed
  • Excellent written and verbal communication skills
  • Excellent interpersonal and collaborative skills

_____________________________________________________________________________________

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. Director, Scientific Communications & Operations

Sr. Director, Scientific Communications & Operations

Job Description

Position Overview:

The Sr. Director, Scientific Communications & Operations will collaborate closely with a cross-functional group to ensure accurate, consistent, and timely communications about Prothena’s science. This role will ensure that scientific and medical strategies are aligned with broader corporate and patient needs. This role will also implement and oversee operations in the Medical Affairs department, including Publications, Training, Medical Review Committee, Medical Information, and Medical Education and Grants. He/she will demonstrate in-depth scientific knowledge of disease states and all relevant research and clinical studies.

Responsibilities:

  • Accountable for defining the strategy for scientific communications and collaborating to develop and execute on comprehensive communication plan for each therapeutic area and/or company asset
  • Build relationships with key corporate partners to align scientific communication strategies and agree on tactics
  • Coordination, development, review, and execution of strategic publication plans to ensure alignment across departments and to ensure deliverables are met within set timelines, including the development, approval and release of manuscripts, abstracts, posters, and slide presentations
  • Collaborate with Research, Clinical, Legal, Communications and outside experts and other groups as needed to ensure that clinical and scientific data is represented accurately in published literature, slide decks and other materials
  • Responsible for coordinating key scientific conference activities, including publications, symposia, advisory boards, sponsorship and booth activity
  • Oversees development of field medical team materials, including slides and FAQ documents
  • Implementation and oversight of Medical Information processes and development and review of standard response letters and other scientific exchange documents, commensurate with company pipeline needs
  • Implementation and oversight of Medical Review Committee and Medical Education and Grants Review Committee, commensurate with company pipeline needs
  • Responsible for development and implementation of appropriate SOPs and strategic initiatives to improve efficiencies
  • Effectively build relationships and work with global medical thought leaders
  • Manage the financial and contractual aspects of assigned projects, including vendor relationships
  • Perform other responsibilities as assigned
Qualifications

Education and Experience:

  • Advanced scientific or clinical degree (PhD, PharmD, or MD preferred) with a minimum of 10 years’ experience in industry (i.e., biotech/pharmaceutical/medical device company, Contract Research Organization)
  • Rare Disease and hematology experience preferred
  • Cardiology and/or neurology experience a plus
  • Must have extensive experience in publication planning and the ability to align key scientific communication objectives with clinical studies and publications
  • Experience with leading peer-reviewed publications, scientific/medical advisory boards, and medical education/communications
  • Experience in collaborating with field-based teams to develop scientific resources including slides and FAQs
  • Experience leading booth development and general conference presence
  • Experience in building and overseeing medical affairs operations, including review committees and SOPs
  • Proficient knowledge in Regulatory, Commercial and Legal environment for drug development and registration, clinical trials, and medical communications
  • Significant experience in literature searches and evaluation, and drug information concepts

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
  • 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
  • Up to 20% 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. 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. Research Associate I

Sr. Research Associate I

Job Description

Position Overview:

Prothena is seeking an experienced histology technician to support research projects in its state-of-the-art histology facility by performing histological procedures, including tissue preparation, sectioning, standard staining, immunostaining, imaging, and image quantification. 

Responsibilities:

  • Carry out immunohistochemical procedures:
    • Preparation of frozen blocks (tissue embedding in OCT)
    • Sectioning of frozen tissue using a cryostat
    • Sectioning of paraffin blocks using a microtome
    • Immunostaining and cover-slipping of tissue
  • Though automated staining will be a key responsibility, the successful candidate will also be capable of performing manual chromogenic and fluorescence IHC, as needed
  • Carry out standard histological staining such as H&E, nuclear counterstaining
  • Use of a microscope to examine the quality of staining or perform standard microscopic tasks
  • Other laboratory tasks include:
    • Shelving and inventory of biospecimens and reagents
    • Maintaining reagent stocks and ordering supplies
    • Keeping laboratory in order and making sure equipment is well maintained
    • Work with CRO for outsourcing of tissue embedding and sectioning, when necessary
    • Collaborate and coordinate sample sharing with other research groups
Qualifications

Education and Experience:

  • Bachelor’s degree or higher preferably with 5+ years of histology experience, including 2+ years in Pharma/Biotech, CRO or a clinical pathology laboratory
  • Experience with chromogenic and fluorescence immunodetection is required
  • Experience using automated stainers including the Leica Bond Rx or Biocare IntelliPATH FLX is highly desired
  • Imaging of slides using Hammamatsu Nanozoomer slide imager is a plus

Competencies and Attributes:

  • Ability to lift 15 pounds, move easily around the lab, or sit for periods of time when required
  • Willing to learn new techniques and the use of new software
  • Must be able to thrive in a fast-paced, science and patient-centric biotech environment.
  • Demonstrated ability to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful.

Note:

  • 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.

____________________________________________________________________________

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. 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.

SVP, Head of Communications

SVP, Head of Communications

Job Description

It is an exciting time as Prothena continues to receive positive data and advances its potentially game-changing pipeline. The company is seeking an entrepreneurial, motivated, and strategic Head of 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 chief architect of Prothena’s communications strategy, the SVP, Head of Communications will have the opportunity to build and 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 COO/CFO, the SVP, Head of Communications will be a welcomed and key advisor to Prothena’s executive team. The position will be based in South San Francisco, California, but there is some flexibility as needed.
Top priorities include:
• Partnering with the SVP of Strategy to further define, refine, optimize, and make more concise the communication of Prothena’s corporate strategy;
• 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.

The Senior Vice President, Head of Communications will:
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 the primary liaison and contact person for the media community; act as company spokesperson 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 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.
• Serve as the Communications lead on Global Project Teams and lead ongoing communications activities for established portfolio programs.
• 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.
• 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.
• 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.

SCIENTIFIC & MEDICAL COMMUNICATIONS
• Lead and 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

• 10+ 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;
• A demonstrated record of leadership success during periods of corporate growth or change; small public company experience is a plus;
• Experience working collaboratively with investors 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;
• Proven strategic and tactical leadership to drive results that are needed to achieve company objectives aligned 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;
• Executive gravitas (confident and credible presence) and facilitation skills with a solutions-oriented mindset to champion a connection between content and value while building excitement and engagement;
• 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 team player who listens effectively and invites response and discussion;
• A strong manager and proven leader who works with the highest level of ethical and professional values in a matrixed environment;
• Ability to partner with the Chief Accounting Officer, Head of Finance, and Investor Relations in managing the company’s financial communications, including quarterly earnings preparation and scripts, media outreach, annual report, and leadership content for investor presentations;
• BA/BS in Marketing, Communications, Journalism, Business Administration, or related area (science degree a plus).

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.

VP, Head of Biometrics

VP, Head of Biometrics

Job Description

Position Overview:

The Head of Biometrics will report to Prothena’s CDO and will be responsible for overseeing and managing the company’s statistical deliverables.  The qualified candidate will be responsible for advancing our current and emerging product pipeline through all stages of development, BLA filing and life-cycle management. 

Responsibilities:

  • Provide leadership in all aspects of quantitative statistical disciplines for all clinical and non-clinical drug discovery and development programs.
  • Provide strategic leadership on the design and development of development plans including regulatory and scientific strategies from pre-IND to Phase 3
  • Build and lead the biometrics department (statisticians, programmers and data management)
  • Oversee statistical, data management and programmer representation on clinical and program teams
  • Integrate and manage internal and external (consultants, contract organizations, etc) biometricians, statistical scientists, programmers and data managers
  • Lead the biometrics team to:
  • Incorporate the medical, scientific, operational, regulatory and technological aspects of a therapeutic area into the statistical strategies suggested for the clinical development program
  • Generate and implement appropriate statistical approaches that accurately address scientific and biologically based questions and make optimal use of the data to be collected
  • Oversee the development of statistical analysis plans, Table, Listing and Figures, and output of top line results following database lock
  • Evaluate complex data sets for evidence of meaningful drug impact thereby generating novel hypotheses within the context of the overall clinical program
  • Input into design of eCRFs, ensuring that data collection parameters are designed to capture protocol specified scientific information as needed for analyses
  • Evaluate and assist in drafting CSRs, Publications and Press Releases
  • Represent the company at relevant scientific, regulatory and clinical meetings
  • Act as key content provider for relevant regulatory documents
  • Address queries from relevant key opinion leaders and regulatory authorities in a timely manner
  • Develop and implement initiatives focused on product market access, commercialization and life-cycle management
  • Share/educate team members on statistical approaches and issues to increase statistical knowledge base of x-functional team members
  • Writes and reviews SOPs for Biometrics and is responsible for the overall compliance and quality of the Biometrics department
  • Support corporate communications and business development diligence efforts
    Responsible for budgeting, resources planning, and vendor management
  • Function as part of the leadership in the development organization and partner with other key functions (clin development, regulatory, etc).
  • Leverage strengths of the current team members within Biometrics, clarify roles and responsibilities as needed and implement appropriate skills development to optimize individual and organizational goals
  • This role is included in the Part-time Product Team Leader (PTL) resource pool, hence may be requested to act as a PTL for development stage assets based on business need.
Qualifications

Education and Experience:

  • PhD (or equivalent) in statistics or related discipline with a demonstrated ability to communicate in fluent English (oral and written).
  • 10+ years of relevant industry experience
  • Expert knowledge and experience with statistical design, implementation, analysis and reporting of scientific results
  • Proven track record in successfully building and leading statistical/biometrics teams and working with external statistical consultants
  • Experience with oversight of Data Management
  • Experience in leading NDA, BLA or CTD submission activities
  • Experience managing external statistical CROs and consultants
  • Familiarity with key EDC systems, such as Medidata RAVE or Oracle InForm
  • Strong understanding of clinical development, quality, standards and policies
  • Excellent understanding of regulatory requirements relevant to statistics
  • Proven ability to work independently under pressure, demonstrating initiative and flexibility through effective and innovative leadership
  • Excellent interpersonal and communication skills and ability to operate effectively in global environment
  • Attention to detail and quality focused

 

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 (imaginative, courageous, selfless and joyful)
  • Solution-oriented, with a demonstrable track record of identifying and solving difficult challenges
  • Thinks inclusively about the role of biometrics in nonclinical and clinical programs
  • Team player with excellent written and verbal communication skills and an ability to easily explain complicated statistical theory
  • Outstanding analytical and negotiation abilities
  • Demonstrated leadership skills
  • Working understanding with ICH guidelines, FDA requirements, as well as similar or related regulatory requirements in the EU

___________________________________________________________________________________

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.