Director, Clinical Pharmacology
Proclinical is currently recruiting for a Director of Clinical Pharmacology for a leading pharmaceutical company with some remote flexibility located in San Diego, CA. As the Clinical Pharmacology Director, you will provide the clinical pharmacology components of clinical development plan and provide clinical pharmacology expertise to the project team including planning, designing and overseeing clinical pharmacology studies with operational assistance from Clinical Operations.
- Act as Clinical Pharmacology Lead in the project team and other sub-teams as appropriate.
- Plan, write, and review the clinical study designs, study protocols, data analysis plans, study reports, and regulatory documents such as IBs, INDs, briefing books for regulatory meetings, and major sections of regulatory filings.
- Use state of the art modeling and simulation approaches to interpret PK/PD data and to integrate PK, PD, safety, and efficacy data to ensure appropriate dose and schedule decisions.
- Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, exposure-response analysis etc.
Skills and Requirements:
- PhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline. Equivalent combination of education and applicable experience may be considered.
- Minimum 6 years of relevant Clinical Pharmacology experience is required.
- Hands-on experience with at least 2 modeling and simulation software (e.g., Phoenix WinNonlin, NONMEM, Berkeley Madonna, R, S-Plus, SimCYP, and GastroPlus) is strongly preferred.
- Prior regulatory interactions and working experience in the preparation of regulatory documents and filings are highly desired.
- Expertise/experience in at least 3-5 of the following areas is required - FIH and/or Ph II/III dose selection, pediatric dose selection and study design, comparability strategies, drug-drug interactions, device and formulation bridging strategies, food-effect studies, QTc assessments, special population studies, and mass balance studies.
- Demonstrates a breadth of diverse leadership experiences and capabilities, including the abilities to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.