Associate Director, Clinical Pharmacology and Pharmacometrics

Role Summary

The Associate Director, Clinical Pharmacology and Pharmacometrics will be responsible for developing and executing clinical pharmacology strategies and serve as the clinical pharmacology lead providing subject matter expertise on clinical study and development project teams. This position will integrate nonclinical ADME, toxicokinetics, PK/PD, and clinical pharmacology to support early clinical development and selection of optimal doses and dose regimens. This role involves strong cross-functional collaboration with internal and external partners, including Discovery Research, ADME, Clinical Operations, Biometrics, Medical Writing, and Regulatory to advance therapeutic candidates in an efficient manner.

Responsibilities

• Represent Clinical Pharmacology on clinical development and project teams
• Contribute directly to clinical pharmacology components of protocols, study reports, and clinical and regulatory documents
• Contribute to clinical program design, author clinical trial protocols, analyses plans, study reports, and regulatory submissions
• Execute and co-ordinate clinical pharmacology studies
• Conduct and oversee pharmacokinetic, pharmacodynamic, population PK/PD and exposure-response analyses, dose selection, and simulation-based trial design
• Communicate results of model-based approaches to internal and external stakeholders
• Interact with cross-functional team members to support translational activities

Qualifications

• Advanced degree (Ph.D., Pharm.D. or MD) in relevant field (e.g. pharmacokinetics, pharmacometrics, clinical pharmacology) with 4+ years of in-depth experience in pharmaceutical/biotech industry
• Hands-on experience and proficiency in use of relevant software (e.g. Phoenix WinNonlin, NLME, NONMEM, R, MATLAB or other PK/PD and pharmacometric modeling and data visualization software)
• Strong background in clinical pharmacology, pharmacokinetics/pharmacodynamics
• Ability to work effectively in a matrixed organization
• Strong verbal and written communication and presentation skills; ability to effectively communicate PK/PD and pharmacometrics concepts to relevant stakeholders
• Excellent interpersonal, communication and time-management skills
• Current knowledge of regulatory guidance related to ADME and clinical pharmacology, experience with IND, NDA or other regulatory documents

Skills

• Pharmacokinetics/pharmacodynamics expertise
• Pharmacometric modeling and data visualization
• Proficiency with PK/PD software (e.g., Phoenix WinNonlin, NLME, NONMEM, R, MATLAB)
• Model-based analysis communication to stakeholders
• Effective cross-functional collaboration
• Strong written and verbal communication

Education

• Advanced degree (Ph.D., Pharm.D. or MD) in a relevant field