Senior Director/Executive Director, Clinical Pharmacology
Newark, California, United States
Job 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
Required Skills & Qualifications
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.
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
Apply
Career Focus: Executive/Senior Management
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