Senior Director/Executive Director, Clinical Pharmacology

Protagonist Therapeutics
  • Newark, New Jersey
    30+ days ago

    Job Description

    Senior Director/Executive Director, Clinical Pharmacology
     
    About Us
    Protagonist Therapeutics is a biopharmaceutical company built on a proprietary peptide technology platform that has now produced two FDA-approved, first-in-class medicines, generating royalties and milestones from global commercial partnerships with Johnson and Johnson and Takeda Pharmaceutical Company Limited. ICOTYDE (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026 for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further clinical and regulatory development and commercialization. Protagonist also discovered and led research and development through Phase 3 for MIMRYLO (rusfertide), a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceutical Company Limited for worldwide commercialization. MIMRYLO is approved in the U.S. for the treatment of erythrocytosis in adults with PV. The Company also has a number of clinical and preclinical programs based on clinically and commercially validated targets and addressing unmet medical needs, including an oral IL-17 antagonist peptide, anti-obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin discovery programs.
    More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.
     
    Position Summary
    Protagonist Therapeutics, Inc is seeking an experienced professional to join the Clinical Pharmacology and Pharmacometrics department. The candidate will lead and execute clinical pharmacology and pharmacometrics efforts for a portfolio of clinical studies, spanning first-in-human through late-stage development.  Working in close partnership with cross-functional partners, the candidate will develop and execute clinical pharmacology plans and serve as a functional representative on development teams and regulatory interactions.  The candidate will contribute to and conduct PK/PD and quantitative analyses and interpretation of clinical pharmacology studies.

    We are committed to a thriving in-office culture. This role requires being on-site at our office in Newark, CA 4 days a week.
     
    Responsibilities
    • Lead the development and execution of integrated clinical pharmacology, pharmacometrics and model-informed drug development activities across all stages of development
    • Provide scientific and strategic leadership and execute population PK, PK/PD, exposure-response, and PBPK modeling to support dose selection, study design, regulatory interactions, and key development decisions
    • Work in partnership with members of cross-functional teams to lead, develop and execute clinical pharmacology plans
    • Provide scientific and operational leadership to progress development candidates from discovery through late-stage clinical development
    • Develop and execute quantitative plans to support clinical development of pipeline projects
    • Contribute to regulatory submissions
    • Mentor and develop clinical pharmacology scientists, fostering scientific excellence, collaboration, and professional growth within the department.
     
    Required Skills & Qualifications
    •  Advanced degree (PhD, MD, PharmD) in pharmaceutical or pharmacology-related discipline or quantitative sciences
    • A minimum of 10 years of industry experience with focus on clinical development or application of quantitative sciences
    • Significant experience with clinical pharmacology, including PK/PD, quantitative sciences, biomarkers and analyses of clinical trials
    • Demonstrated experience developing and executing clinical pharmacology programs supporting first-in-human and clinical development programs
    • Demonstrated ability to manage multiple priorities and be productive and successful working cross-functionally in a fast-paced, matrixed organization
    • Strong scientific background, demonstrated through peer-reviewed publications, regulatory interactions, and presentations.
    • Working knowledge of regulatory guidance related to clinical pharmacology and pharmacokinetics
    • Excellent written and oral communication, including ability to convey complex concepts, with the ability to build strong working relationships with colleagues, cross-functional teams, and external partners
    • Attention to detail with a consistent focus on quality
    • Ability to effectively present information to stakeholders
    Pay Range
    The base pay range for this position at commencement of employment is expected to be between $275,000 and $310,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
     
    Benefits
    A top priority for Protagonist Therapeutics, Inc. is to provide a robust and comprehensive health and wellness program for our employees and their families. We offer a variety of high-quality coverage and benefit options.
    • Health Care benefits. Protagonist covers 100% of the premium cost for medical, dental, and vision coverage for all full-time employees and their dependents.
    • Flexible Spending Accounts – Healthcare FSA, Dependent Care FSA, Commuter Benefits
    • 401(k) Plan
    • Flexible Vacation Policy
    • Life Insurance (Basic, Voluntary & AD&D)
    • Short Term & Long Term Disability
    • Company paid lunch and snacks

    Numbers & Facts

    LocationNewark, New Jersey
    Websitehttps://www.protagonist-inc.com/careers

    Skills

    • Analysis Skillsunmatched
    • Biomarkersunmatched
    • Biotech and Pharmaceuticalunmatched
    • Candidate Pipelineunmatched
    • Clinical Information Systemsunmatched
    • Clinical Pharmacologyunmatched
    • Clinical Practices/Protocolsunmatched
    • Clinical Supportunmatched
    • Clinical Trialunmatched
    • Communication Skillsunmatched
    • Cross-Functionalunmatched
    • Detail Orientedunmatched
    • Diseaseunmatched
    • Drug Developmentunmatched
    • FDA (Food and Drug Administration)unmatched
    • Intellectual Property (IP)unmatched
    • Leadershipunmatched
    • Matrix Managementunmatched
    • Medical Productsunmatched
    • Mentoringunmatched
    • Multitaskingunmatched
    • Obesityunmatched
    • Pediatricsunmatched
    • Pharmacokineticsunmatched
    • Pharmacologyunmatched
    • Pharmacology Researchunmatched
    • Presentation/Verbal Skillsunmatched
    • Project Developmentunmatched
    • Publicationsunmatched
    • Quantitative Analysisunmatched
    • Regulationsunmatched
    • Regulatory Submissionsunmatched
    • Research & Development (R&D)unmatched
    • Royaltiesunmatched
    • Sales Pipelineunmatched
    • Team Lead/Managerunmatched
    • Writing Skillsunmatched

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