Director, Clinical Pharmacology
About The Position
As Director, Clinical Pharmacology, you will lead the design and execution of clinical pharmacology strategies across multiple programs, reporting directly to the Chief Medical Officer. You will serve as the subject matter expert for pharmacokinetics (PK), pharmacodynamics (PD), and modeling approaches to optimize dose selection and support regulatory submissions. On a day-to-day basis, you will oversee clinical pharmacology components of protocols, manage bioanalytical and PK/PD modeling activities, and collaborate with cross-functional teams to ensure robust data interpretation and compliance with regulatory standards. Given the novel biology studied by Triveni, you will have robust and frequent interactions with the research group to help develop the custom assays, elucidate PK/PD relationships, and ultimately lead the modeling necessary to ensure optimization of dose. You must have broad experience in clinical pharmacology within the biopharmaceutical industry, including a proven track record of advancing programs through multiple phases. Experience in the I&I space and experience with novel biology are strongly preferred. This role offers exposure to strategic decision-making and the opportunity to influence the future of precision medicine in immunology and inflammation.
Requirements
- Advanced degree (PhD, PharmD, or MD) in Clinical Pharmacology or related discipline required.
- 10+ years of experience in clinical pharmacology within the biopharmaceutical industry.
- Strong understanding of global regulatory requirements for clinical pharmacology.
- Leadership experience managing cross-functional teams and external vendors.
Nice To Haves
- Experience with biologics and immunology/inflammation indications strongly preferred
Responsibilities
- Define and implement clinical pharmacology strategies across multiple programs.
- Lead PK/PD modeling, dose selection, and bioanalytical planning.
- Author and review clinical pharmacology sections of protocols, regulatory documents, and submissions.
- Collaborate with Clinical Development, Research, Regulatory Affairs, Biostatistics, and Clinical Operations to ensure integrated plans.
- Represent Clinical Pharmacology in governance committees and regulatory interactions.
- Oversee vendor management for bioanalytical and modeling activities.
- Ensure adherence to GCP, ICH guidelines, and all applicable regulatory requirements.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
11-50 employees
