What are the responsibilities and job description for the Director Clinical Pharmacology position at EPM Scientific?
Role Overview : The Director of Clinical Pharmacology & Pharmacometrics will leverage their scientific, technical, and leadership expertise to craft and execute strategies in clinical pharmacology and modeling & simulation, propelling drug candidates through various development stages. Collaborating closely with discovery and development teams, this role provides strategic and technical insights as a key member of the project development team. The Director also plays a pivotal role in departmental growth and may mentor or manage junior clinical pharmacologists.
Key Responsibilities :
- Formulate and implement clinical pharmacology and pharmacometrics strategies to advance programs from research to post-marketing.
- Act as the clinical pharmacology lead on project teams, offering expertise in PK / PD, biopharmaceutics, drug-drug interactions, and quantitative pharmacology.
- Guide the development of small molecules and biologics through milestones such as IND / CTA, EOP2, and marketing applications.
- Conduct and oversee PK / PD and exposure-response analyses using advanced modeling and simulation techniques to support human PK predictions, dose selection, trial designs, risk / benefit assessments, regulatory submissions, and publications.
- Collaborate with various functional partners, including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory, to achieve project and corporate goals.
- Enhance external scientific visibility and publication efforts.
- Engage with internal and external scientific experts to evaluate and adopt new methods, ensuring cutting-edge techniques and capabilities.
- Ensure compliance with SHE policies, GXPs, and regulatory standards in clinical pharmacology programs.
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