Open Positions

Associate Director, Clinical Trial Management

Associate Director, Clinical Trial Management

Job Description

Position Overview:

The Associate Director, Clinical Trial Management will lead the delivery of clinical study(ies), ensuring they are conducted on time, within budget, and of appropriate quality. This individual may have line management responsibilities.

Responsibilities:

  • Responsible for the successful execution of one or more clinical studies from study planning to close-out
  • Leads cross-functional Study Management Team meetings; facilitates discussions and decision-making across functions
  • Manages study finances. Negotiates vendor contracts, ensuring clarity in contracts and budgets, and oversees vendor performance to contract and agreed budget.
  • Participates in development of study timelines, ensuring close coordination between the Prothena study team and external parties. Manages trial according to agreed timelines
  • Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs
  • Communicates risks to timelines, budgets, or quality and participates in establishing and overseeing mitigation strategies
  • Leads site and vendor selection activities and oversees Trial Master File management
  • Oversees the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and ensures trial activities are conducted 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 Experience:

  • Bachelor’s degree in scientific discipline required; master’s degree or higher preferred
  • At least 8 years’ experience in clinical operations in biotech / pharma companies and/or CRO
  • Experience managing Phase 1-3 multinational clinical trials, including successful management of cross-functional teams
  • Experience with vendor and site selection, contracts and budgeting, and vendor and site oversight
  • Demonstrated expertise in Good Clinical Practice; experience with sponsor regulatory inspection(s) preferred
  • Working knowledge of data management, regulatory operations, and pharmacovigilance
  • 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
  • Strong written and verbal communication skills
  • Excellent problem-solving skills and a strong sense of urgency
  • Strong interpersonal 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.

Associate Director, Intellectual Property

Associate Director, Intellectual Property

Job Description

Position Overview:

The Associate Director, Intellectual Property will 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, leading the effort from initial filings to worldwide patent issuance, and supporting R&D and business development efforts. 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 Vice President, Intellectual Property.

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 and legal matters, as needed.
Qualifications

Education and Experience:

  • 5+ years of experience in drafting and prosecuting U.S. and worldwide patent applications, developing strategic patent portfolios, and conducting patentability and freedom-to-operate analyses.
  • Admission to practice before the USPTO and in good standing. Patent attorneys required to have a J.D. and admission in good standing to a state bar.
  • 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.
  • Experience supporting company transactions, licenses, collaborations, and partnerships desired.
  • 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.
  • Excellent oral and written communication skills.

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.
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, Clinical Science

Director/Sr. Director, Clinical Science

Job Description

Prothena is actively building its Clinical Science team as a key component of the Clinical Development organization.  Clinical Scientists will participate in the design, planning, execution and delivery of results of clinical studies and the interpretation of study results for all pipeline molecules throughout the company.

An integral part of the clinical development team, Clinical Science participates/leads the creation of the clinical development strategy and plan for a molecule(s).  They also support Medical Directors with clinical trial conduct and act as the primary internal and external point of contact for the Clinical Development organization. 

Members of the Clinical Science team will:

  • Serve as the lead representative for Clinical Science on the molecule(s) global product team, study management team, and other molecule sub-teams as needed.
  • Take 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).
  • Be 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).
  • Be 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.
  • Work in collaboration with others on the study management team to ensure the Trial Master File (TMF) remains up to date, as well as in compliance with the overall study data quality plan.
  • Be responsible for the conduct of ongoing medical/safety data reviews and medical monitoring.
  • Serve as the primary point of contact for vendors and trial sites for questions regarding the clinical protocol.
  • Act as a key participant in study start-up, study data base lock, data cleaning, study results interpretation, and study close-out.
  • Participate and present, as needed, during interactions with key opinion leaders, investigator meetings, health authority meetings, study site visits, site training, and health authority inspections as the lead clinical science representative.
  • Serve as the clinical science representative for pre-clinical molecules and partnering due diligence.
  • Participate in developing and writing scientific/clinical abstracts, posters, conference presentations, and manuscripts.
  • Manage one or more direct reports, typically other Clinical Scientists.

Remain 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
  • The Candidate will have an bachelor’s degree, preferably in life sciences
  • The Candidate will have a minimum of 3+ years of hands-on clinical science/development experience within the biopharmaceutical industry
  • Experience across various phases of development
  • The Candidate will have experience with FDA/EMA interactions, as well as evidence of collaborating with key opinion leaders across the industry.
  • Proficient in medical terminology and medical writing skills.
  • Deep knowledge of GCP, ICH, and FDA guidelines
  • The Candidate will have strong expertise in writing protocols, authoring trials, trial design methodologies, statistical aspects of data analysis, and regulatory requirements related to clinical development.
  • The Candidate will have excellent communication, collaboration and organizational skills and be able to exercise sound critical thinking and problem-solving skills while building constructive, trusting, and respectful relationships.
  • The Candidate is experienced to work in cross-functional teams and matrix organization.
  • The candidate will have the ability to be self-directed and operate effectively in an evolving organizational structure with minimal direction.

 

Additional Preferred Attributes:

  • Advanced degree preferred (MS, PhD, PharmD)
  • Neuroscience or rare diseases.
  • Experience working with large molecule drug candidates.
  • Existing relationships & experience interacting with key opinion leaders in the target disease areas.
  • 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.
  • Experiences in design and interpretation clinical trials with biomarkers (fluid based biomarkers, molecular imaging, structural or functional MRI)
  • Experiences in design and implementation of clinical trials with cognitive or psycho-behavioral endpoints
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.

Executive Administrator

Executive Administrator

Job Description

Position Overview:

The ideal candidate will be a senior-level EA, experienced in handling a wide range of administrative and executive support related tasks and will be able to work independently with little or no supervision. This person must be exceedingly well organized, flexible and enjoy the administrative challenges of supporting high level executives.
Personality is equally as important as experience and must be able to formulate decisions and execute independently with a high degree of efficiency and accuracy.


The ability to interact with staff (at all levels) in a fast paced environment, sometimes under pressure, remaining flexible, proactive, resourceful, and efficient, with a high level of professionalism and confidentiality is crucial to this role. Exceptional written and verbal communication skills, strong independent decision-making ability and attention to detail are critically important.

Responsibilities:

  • Act as liaison to maximize executive’s focus on priorities
  • Manage busy and ever-changing business calendars
  • Handle arrangements for all executive-sponsored events
  • Arrange travel schedule and reservations for executives, as well as manage expense reports
  • Handle multiple requests for time on executive’s calendar and utilize strong judgement in managing priorities of requests and escalating, as necessary, for resolution and/or prioritization
  • Responsible for heavy calendar management, requiring interaction with both internal and external executives and assistants, as well as 3rd parties, to coordinate a variety of complex executive meetings
  • Plan, coordinate, and facilitate on-site and off-site meetings and functions
  • Assist executive with preparation of presentation materials
  • Review and summarize select reports and documents; prepare background documents and outgoing mail as necessary
  • Prioritize and manage multiple projects simultaneously, and follow through on issues in a timely manner
  • Assist other executive administrators and provide back-up, when necessary
Qualifications

Education and/or Experience:

  • BA/BS or equivalent experience
  • Minimum of seven (7) years of experience supporting C-level executives
  • Experience required in biotech (supporting senior level business/corporate development executives) or senior leaders in other high-paced industries (e.g., banking, venture capital)
  • A track record of exemplary tenure over the course of his/her career
  • Excellent calendar management skills, including the coordination of complex executive meetings
  • Experience assisting executive with the creation and editing of presentations and reports within PowerPoint, Excel or other MS Office products
  • Deep experience scheduling travel arrangements for a highly mobile set of executives and their teams
  • Flexibility to adapt to rapid changes, with ability to quickly make ad hoc changes to schedules or processes
  • Experience successfully creating and/or modifying processes
  • Availability to perform job duties outside of normal business hours, when necessary

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, polished, and independent personality with a high degree of intellectual horsepower
  • Strong knowledge of MS Office, including Word, Excel, PowerPoint and Outlook
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. Manager/Associate Director, Medical Writing

Sr. Manager/Associate Director, Medical Writing

Job Description

Position Overview:

The position, reporting to the Sr. Director, Head of Global Regulatory Portfolio Management, with a dotted line report to the Interim Head of Medical Writing, will be the medical writing lead for clinical regulatory documents. A successful medical writer will be able to write independently and work effectively with cross-functional colleagues to develop documents efficiently and with high quality.

Responsibilities:

  • Write or oversee the writing of regulatory submission documents (e.g., clinical protocols, investigator brochures [IBs], clinical study reports [CSRs], eCTD/BLA clinical summaries, and briefing documents for regulatory interactions)
  • Maintain timelines and ensure smooth and effective document management from conception to final signature (i.e., generation of a blank document to a final approved version), including management of various processes (e.g., QC, formatting, publishing, document archiving)
  • Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required to ensure adherence to standards
  • Lead or oversee document review and comment resolution meetings with cross-functional teams
  • Interpret clinical study data as needed for document preparation
  • Perform literature-based research to support writing activities as needed
Qualifications

Requirements:

Education and Experience:

  • BS, MS, or doctorate in a scientific or medical field
  • 8+ years of experience within the biotechnology/pharmaceutical industry with 5+ years of medical writing experience for clinical regulatory documents
  • Experience in rare diseases, and/or neuroscience preferred
  • Demonstrated experience as a primary author, writing and editing regulatory scientific documents; preparation of protocols, IBs, CSRs, briefing documents for regulatory interactions and experience on at least one eCTD/NDA/BLA/MAA submission
  • Experience with global clinical study/regulatory submission preferred
  • Strong document management and project management skills, along with initiative and ability to be productive with minimal supervision
  • Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures
  • Understands and effectively responds to multicultural communication styles and business practices with internal colleagues and vendors
  • Ability to build and maintain effective partnerships, both internally and externally

Competencies and Attributes:

  • Demonstrated leadership ability to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Exceptional oral and written communication skills
  • Flexible; adapts work style to meet organization needs
  • Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
  • Dedicated to quality and reliability
  • Excellent computer skills (Veeva, Microsoft Office Suite; Project and Visio experience a plus)
  • Approximately 10% travel is anticipated
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 Director, Hematology

Sr. Medical Director, Hematology

Job Description

Position Overview:

The Sr. Medical Director, Hematology will provide medical leadership for Prothena’s rare peripheral amyloid disease portfolio. This role is responsible for creating medical strategy and overseeing the implementation of medical operating plans for the therapeutic area, including leading advisory boards, medical affairs studies, and collaborating with global thought leaders. This role will also provide medical guidance to publications, training, resources, and field activities. He/she will interface with multiple internal functions including Medical Science Liaisons (MSLs), Clinical Development, Research, Drug Safety, Market Access, and Commercial to ensure corporate alignment. He/she will demonstrate in-depth scientific knowledge of the therapeutic area and all relevant research and clinical studies.

Responsibilities:

  • Develops annual Medical Operating Plan and oversees the implementation of medical tactics across the Medical Affairs organization
  • Collaborates with Medical Communications team to provide input and expertise on communication plans and associated resources for therapeutic area
  • Engages closely with global thought leaders in therapeutic area, in close collaboration with field based MSL team. Demonstrates leadership and commitment through innovative partnerships and projects
  • Plans and leads advisory board meetings with thought leaders to receive feedback on scientific and clinical landscape and company development activities
  • Provides medical guidance to and oversees the analysis of scientific datasets with thought leader collaborators, leading to scientific presentations and publications
  • Leads investigator-initiated study committee and participates in the review and approval of research initiatives and grants
  • Leads medical affairs studies and registries in therapeutic area, as appropriate
  • Participates in scientific conference activities and provides medical oversight for publications, symposia, and medical booth activities
  • Develops and leads training programs in collaboration with field-based medical team
  • Build relationships with key cross-functional corporate partners to align medical strategies and agree on tactics
  • Perform other responsibilities as assigned
Qualifications

Education and Experience:

  • Advanced degree (PharmD, MD, PhD) is required. Medical degree strongly preferred
  • A minimum of 8 years of relevant experience in industry (e.g., Medical Affairs, Clinical Development) or academia; 5+ years in Hematology
  • Extensive experience in medical affairs strategy and developing medical operating plans and budgets
  • Proven history of collaborating with thought leaders in hematology
  • Experience with leading peer-reviewed publications, scientific/medical advisory boards, congress activities, medical review, and training
  • Proficient knowledge in Regulatory, Commercial and Legal environment for drug development and registration, clinical trials, and medical communications

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve the company objectives in accord with the Prothena’s culture and values - courageous, imaginative, selfless, and joyful
  • Strong 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
  • 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
  • Ability to work effectively in a cross-functional environment
  • Ability to manage timelines, multiple priorities under time constraints
  • Strong analytical and problem-solving skills
  • Up to 30% 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. Research Associate I, In Vivo Pharmacology

Sr. Research Associate I, In Vivo Pharmacology

Job Description

Position Overview:

The In Vivo Pharmacology group is seeking an independent and motivated Senior Research Associate to join a research team focused on the discovery and development of novel therapeutics for central nervous system diseases. The qualified candidate must be scientifically driven and will participate in antibody discovery by aiding with the design, execution, and reporting of preclinical in vivo studies. The candidate will be expected to support multiple Research projects and communicate effectively to their manager and to program leaders.

Responsibilities:

  • Perform in vivo pharmacology studies to support drug discovery projects
  • With guidance from supervisor plan, execute, analyze, and document in vivo studies
  • Work in a team environment
  • Oversee studies performed at contract research organizations (CROs) as needed
  • Assist in maintenance of the animal facility and labs
  • May participate as member of site IACUC
Qualifications

Education and Experience:

  • Bachelor’s degree in Biology or equivalent field with a minimum 2 years of hands-on lab experience
  • Proficiency handling rodents, dosing by various routes of administration, and collection of biosamples is required
  • Experience with surgical techniques or stereotaxic injections is a plus

Competencies and Attributes:

  • Willingness to work to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
  • Highly organized, attention-oriented, and able to multitask to deliver results that drive projects forward in a timely manner
  • Must be independent, self-motivated, and creative with good oral and written communication skills
  • Familiarity with standard Office software suite (Word, Excel, PowerPoint, etc.) is necessary
  • Able to work in a highly collaborative environment
About Us

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

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

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

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