Associate Scientific Director, Clinical Pharmacology

Role Summary

Associate Scientific Director, Clinical Pharmacology — lead clinical pharmacology efforts on program and study teams, guiding development and execution of clinical pharmacology plans, optimizing doses and study designs across 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 and implement the clinical pharmacology development plan, considering strategic, scientific, translational, and clinical aspects
• Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies
• Lead execution of clinical pharmacology studies and 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 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 knowledge of regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent

Qualifications

• PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or related field
• 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)
• Ability to analyze and interpret PK and PK/PD data
• Experience designing and implementing elements of clinical studies and/or dedicated Clinical Pharmacology studies
• Ability to develop Clinical Pharmacology strategy within the broader development paradigm
• Knowledge of regulatory and ICH guidelines for clinical pharmacology data
• Experience with PK/PD software such as Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS
• Excellent oral and written communication skills for interactions with multidisciplinary teams, regulatory agencies, scientific forums, and advisory boards

Skills

• PK/PD modeling and translational science
• Model-Informed Drug Development (MIDD) application
• Cross-functional collaboration and strategic thinking

Education

• As listed in Qualifications