Lead clinical pharmacology strategy at Certara, applying pharmacometrics and quantitative modeling across multidisciplinary drug development programs. Shape decisions from translation through regulatory submissions.
As Senior Director of Clinical Pharmacology, you will guide development, clinical pharmacology, and regulatory engagements from early translation through late development. You will collaborate with clients and Certara teams on fit-for-purpose strategies, clinical trials, and regulatory decisions. The work spans small molecules, biologics, and broad therapeutic areas.
Key Responsibilities:
- Lead multidisciplinary teams across clinical pharmacology and regulatory engagements
- Develop quantitative program strategies supporting IND through NDA or BLA decisions
- Apply modeling and simulation to clinical trial design
- Represent clients before global health authorities as subject matter expert
- Author clinical pharmacology reports, CSRs, and regulatory documents
Requirements:
- PhD, PharmD, or equivalent scientific degree
- At least 12 years of clinical pharmacology experience
- Applied development expertise in clinical pharmacology stewardship
- Experience designing clinical pharmacology studies and regulatory submissions
- Experience building and leading successful multidisciplinary teams
Bring advanced clinical pharmacology expertise, pharmacometrics judgment, and team leadership to Certara’s drug development programs.
📌 Senior Clinical Pharmacology Director (Canada)
🏢 Certara
📍 Canada
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