Director, Pharmacometrics

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Requirements:

• Pharm.D/Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles.
• Significant industry experience (Director: MS and 10+ years of experience) in clinical pharmacology data analysis and interpretation.
• Extensive experience in population PK and exposure-response analysis using Phoenix NLME, NONMEM, Pumas or related software and requisite programming skills in SAS, R, or similar.
• Familiarity with all stages of clinical drug development, including experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects.
• Experience working in a cross functional team and matrix environment.
• Strong written, presentation and verbal communication skills.
• Ability to influence business leaders at all levels.
• Critical thinker with strong problem-solving skills.
• Demonstrated leadership, strategic thinking, collaboration, and management skills to oversee and develop in-house pharmacometrics capabilities.

Responsibilities:

• Contribute to pharmacometrics strategy and related clinical development plan, consistent with the program goals and the US and international regulatory guidance/guideline of small molecule therapeutics.
• Collaborate with project team members and partner CROs to conduct appropriate pharmacometric analyses (population PK, PK-PD, exposure-response, PBPK, simulations, etc.) to answer development questions
• Work within program teams to understand and anticipate the quantitative needs of each project
• Contribute to efficient clinical study designs with respect to PK and PD
• Assist in formulation of program- and study-level analysis plans
• Hands-on use of modeling and simulation tools to understand complex PK, PK/PD, and exposure-response data
• Interpret analysis results, generating actionable conclusions and new hypotheses
• Communicate model-informed interpretations and advice to project teams
• Participate in preparation of pharmacometrics-related sections of various regulatory documents (INDs, NDAs, IBs, etc.).
• Determine department/function objectives and assign tasks, goals, and development of direct reports and other team members.
• Develop departmental processes to achieve department and corporate objectives
• Other duties as assigned