Senior Director/Executive Director, Clinical Pharmacology

Protagonist Therapeutics • Newark, NJ

1d • Onsite

About The Position

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.

Requirements

• 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

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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree