Director, Clinical Pharmacology
About The Position
The Director, Clinical Pharmacology, plays a pivotal role in leading clinical pharmacology activities to support drug development programs. The incumbent will apply model-informed drug development (MIDD) approaches to optimize the benefit-risk profile of oncologic drugs, while increasing the probability of success and efficiency of drug development programs. This position also involves designing and executing clinical pharmacology aspect of clinical studies, conducting and interpreting pharmacokinetic (PK), PK/pharmacodynamic (PD) and exposure(E)/response (R) analyses, collaborating with interdisciplinary teams, and contributing to regulatory filings and interactions. This is an onsite position in San Diego.
Requirements
- Ph.D. or PharmD or equivalent in life sciences, pharmaceutical sciences or related field.
- 5 to 10 years of related experience.
- Strong hands-on experience with pharmacometrics software (e.g., NONMEM, Monolix, Phoenix WinNonlin, R).
- Understanding of drug development in oncology or other therapeutic areas.
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies.
- Excellent interpersonal, leadership, communication and time-management skills are essential.
Responsibilities
- Act as clinical pharmacology lead in study teams and provide clinical pharmacology expertise to study design, data analysis and interpretation, and overseeing clinical pharmacology studies by working with CROs.
- Responsible for conducting non-compartmental analysis of human clinical PK data, and PK and PK/PD analyses including population PK, PK/PD and Exposure/response modeling and simulation, and meta-analysis.
- Provide the clinical pharmacology components of Clinical Development Plans, IBs, and regulatory documents such as INDs, Briefing documents, responses to regulatory queries, etc.
- Design, author and/or review clinical (pharmacology) study protocols, including PK/PD, drug-drug interaction (DDI), bioavailability, and first-in-human studies, and support the execution of clinical trials when applicable, conduct pharmacometrics analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions.
- Provide Clinical Pharmacology expertise to discovery team during the pre-clinical stages of drug development and works with research colleagues to ensure quantitative mechanistic understanding of preclinical PK-PD data to inform human administration.
- Develop a MIDD strategy that integrates nonclinical data, quantitative understanding of the relationship among dose, PK, PD, efficacy and safety endpoints in the context of heterogeneous diseases (e.g., biomarkers), patient populations (e.g., intrinsic and extrinsic factors) and competitive landscape to make go/no go decisions, support dose and dosing regimen selection, and optimize preclinical and clinical study designs (sample size, duration, endpoints) throughout drug discovery and development.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
