Senior Director/Executive Director, Clinical Pharmacology

Protagonist Therapeutics

  • Newark, New Jersey
  • 2 days ago
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    Skills

    • Analysis Skillsunmatched
    • Biomarkersunmatched
    • Biotech and Pharmaceuticalunmatched
    • Candidate Pipelineunmatched
    • Clinical Information Systemsunmatched
    • Clinical Pharmacologyunmatched
    • 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
    • Mentoringunmatched
    • Multitaskingunmatched
    • Obesityunmatched
    • Pediatricsunmatched
    • Pharmacokineticsunmatched
    • Pharmacologyunmatched
    • Pharmacology Researchunmatched
    • Presentation/Verbal Skillsunmatched
    • Project Developmentunmatched
    • Publicationsunmatched
    • Quantitative Analysisunmatched
    • Regulationsunmatched
    • Regulatory Submissionsunmatched
    • Sales Pipelineunmatched
    • Team Lead/Managerunmatched
    • Writing Skillsunmatched

    Description

    Senior Director/Executive Director, Clinical Pharmacology
    About Us
    Protagonist Therapeutics is a discovery-through-late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. 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, is approved 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 development and commercialization. Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the treatment of polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin 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

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