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Clinical Pharmacology Director
2 months ago
Pliant Therapeutics is seeking a highly skilled and experienced Clinical Pharmacology Director to join our team in South San Francisco. As a key member of our Clinical Pharmacology department, you will be responsible for leading the development of clinical pharmacology strategies and plans across multiple indications.
Key Responsibilities- Study Director: Serve as the study director for Phase 1 studies, including first-in-man, biopharmaceutics, drug-drug interactions, special populations, and proof-of-pharmacology/concept studies.
- Cross-Functional Collaboration: Provide functional representation at project team meetings, seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors.
- Regulatory Submissions: Act as lead author and key contributor to develop clinical pharmacology sections of clinical and regulatory documents, including clinical protocols and study reports, statistical analysis plans, IND and IMPD submissions, regulatory briefing documents, pediatric investigational plans, NDA and/or MAA submissions.
- Modeling and Simulation: Develop high-quality clinical pharmacology plans and author related content for global regulatory submissions, including INDs, IMPDs, CTAs, IBs, NDAs, MAAs, and pediatric investigational plans.
- Vendor Management: Establish and develop working relationships with contract research organizations and bioanalytic vendors and provide clinical pharmacology oversight.
- Regulatory Compliance: Ensure that Phase 1 clinical studies are conducted in compliance with GCP, company SOPs, governing laws, and regulations.
- Project Management: Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
- Education: PhD degree in pharmaceutics, pharmacokinetics, pharmacology, or related discipline.
- Experience: 8+ years of biotech/pharma drug development experience with deep expertise in clinical pharmacology.
- Skills: Excellent working knowledge of clinical pharmacology (pharmacokinetics, pharmacodynamics, translational medicine) and drug development principles, in-depth knowledge of population PK, PK/PD, PBPK modeling concepts, data analysis, and interpretation.
- Regulatory Experience: Good working knowledge of FDA, EMA, and ICH regulations and ability to incorporate relevant regulatory requirements into development plans, study design, and ensure adherence to regulations, including GCP requirements during study conduct.
- Communication: Ability to interpret and communicate complex scientific concepts in a concise and clear manner to an audience with various levels of expertise.
- Leadership: Confidence and ability to present to senior leaders and influence decision-making within the organization.
