Associate Director Clinical Pharmacology San Francisco Biotech
New Position : Associate Director Clinical Pharmacology San Francisco Biotech
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Position Summary : The Associate Director role will have a broad range of responsibilities and oversight of programs in oncology, inflammation, and respiratory.
This is a strategic role requiring appropriate experience and technical skills, but it also requires hands-on exposure and the desire to be in touch with the data.
The candidate will be responsible for all aspects of clinical pharmacology for large and small molecule drug candidates spanning from pre-IND through Phase IV global filings.
The ideal candidate will have a PhD or PharmD in a related science with a minimum of 8 years’ experience in a drug-discovery setting of a biopharmaceutical company.
Responsibilities Include :
- Delivery of clinical pharmacology, PK, PK / PD, and / or population PK initiatives, based on efficient and innovative study design, analysis, interpretation, and reporting for small and large molecules.
- Represent and provide clinical pharmacology expertise and leadership at cross-functional development project team, clinical subteam, study team, partnering with clinical research, biometrics, project management, clinical operations, drug metabolism, biology / biomarkers, toxicology etc.
- Provide clinical pharmacology expertise in the preparation of regulatory submissions (i.e., IB, IND, NDA, MAA, BLA).
- Experience with international regulatory standards, practices and agencies desired.
- Work closely with bioanalytical team within the clinical pharmacology group to ensure high quality and timely deliverables for small and large molecule PK.
- Mentor and manage scientists within the clinical pharmacology group.
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