Associate Scientific Director, Clinical Pharmacology

Role Summary

Associate Scientific Director, Clinical Pharmacology - serve as the clinical pharmacology lead on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. Integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for doses, dosage regimens, and study designs throughout the drug development lifecycle.

Responsibilities

• Provide clinical pharmacology expertise to program and study teams throughout a molecule‚Äôs lifecycle (discovery through development)
• Provide functional representation on development program and study teams
• Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical)
• Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies
• Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results
• Serve as lead author and key contributor to clinical pharmacology sections of clinical and regulatory documents
• Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed
• Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes
• Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent

Qualifications

• PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields
• 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)
• Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles
• Experience designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies
• Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm
• Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data
• Experience with use of PK/PD software packages such as Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS
• Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards

Skills

• Deep expertise in PK/PD modeling, quantitative pharmacology, and translational science
• Hands-on experience leading clinical pharmacology strategy across early and late-stage development
• Model-Informed Drug Development (MIDD) principles to optimize dose selection, study design, and regulatory strategy
• Strong cross-functional collaboration and strategic thinking