Associate Director, Clinical Pharmacology and Pharmacometrics

Position: Associate Director, Clinical Pharmacology and Pharmacometrics

Location: Newark, CA

Job : 387

# of Openings: 0

The Associate Director, Clinical Pharmacology and Pharmacometrics will be responsible for developing and executing clinical pharmacology strategies and serve as the clinical pharmacology lead providing subject matter expertise on clinical study and development project teams. This position will integrate nonclinical ADME, toxicokinetics, PK/PD, and clinical pharmacology to support early clinical development and selection of optimal doses and dose regimens. This role involves strong cross-functional collaboration with internal and external partners, including Discovery Research, ADME, Clinical Operations, Biometrics, Medical Writing, and Regulatory to advance therapeutic candidates in an efficient manner.

• Represent Clinical Pharmacology on clinical development and project teams
• Contribute directly to clinical pharmacology components of protocols, study reports, and clinical and regulatory documents.
• Contribute to clinical program design, author clinical trial protocols, analyses plans, study reports, and regulatory submissions.
• Execute and co-ordinate clinical pharmacology studies
• Conduct and oversee pharmacokinetic, pharmacodynamic, population PK/PD and exposure-response analyses, dose selection, and simulation-based trial design.
• Communicate results of model-based approaches to internal and external stakeholders
• Interact with cross-functional team members to support translational activities

• Advanced degree (Ph.D., Pharm.
  
  D. or MD) in relevant field (e.g. pharmacokinetics, pharmacometrics, clinical pharmacology) with 4+ years of in-depth experience in pharmaceutical/biotech industry
• Hands‑on experience and proficiency in use of relevant software (e.g. Phoenix Win Nonlin, NLME, NONMEM, R, MATLAB or other PK/PD and pharmacometric modeling and data visualization software).
• Strong background in clinical pharmacology, pharmacokinetics/pharmacodynamics
• Ability to work effectively in a matrixed organization
• Strong verbal and written communication and presentation skills; ability to effectively communicate PK/PD and pharmacometrics concepts to relevant stakeholders.
• Excellent interpersonal, communication and time-management skills.
• Current knowledge of regulatory guidance related to ADME and clinical pharmacology, experience with IND, NDA or other regulatory documents.

The base pay range for this position at commencement of employment is expected to be between $190K and 215K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Janssen Biotech, Inc.,

a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV).

Rusfertide is being co‑developed and will be co‑commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre‑clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program.