AD/Director Clinical Pharmacology and M&S
- The Director of Clinical Pharmacology is accountable for planning and integrating clinical pharmacology studies, which meet standards of excellence, ethical, regulatory, and legal requirements, into overall clinical development program objectives. The Director ensures that clinical pharmacology studies meet agreed timelines and budget and deliver pivotal, decision-making knowledge for the programs.
- Contributes to functional excellence in science, including population modeling and simulation applications in drug development and regulatory science. Maintains contact and establishes strong reputation with the external scientific community through publications and other initiatives.
- Defines resourcing and outsourcing strategy for the operational aspects of clinical pharmacology and external collaborations in modeling and simulation. Directly oversees critical path activities with external partners.
- Manages Associates/Assistants, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.
- Serves as internal consultant for all development teams.
- Defines future directions for Translational Medicine, especially in areas related to novel methodology in clinical science and pharmacometrics.
Education level and/or relevant experience(s):
- A Ph.D. degree in pharmaceutics or Pharm D is preferred.
- 10-15 years+ experience in drug development science, including drug metabolism, PK, PK/PD, biomarkers, writing and regulatory interactions.
Knowledge and skills (general and technical):
- Clinical Pharmacology Study Planning – Thorough understanding and experience in the planning and execution of phase 1 volunteer studies (i.e., clinical trial management of phase 1 studies); Experience with multiple phase 1 units that concentrate in; special populations (elderly, pediatric) RI-AME, First in Man, Impairment, PET/EEG and DDI; Knowledge of clinical pharmacology study requirements including protocol input, CSR’s, and other program documents.
- Cutting-edge knowledge of pharmacometric science and regulatory applications of modeling a simulation in drug development.
- Excellent communication and negotiation skills; Ability to function in a cross-cultural environment.
- Exceptional interpersonal skills (globally, internally and externally).
- High level of initiative and ability to work independently under minimal supervision.
- Proven ability to support innovation even if taken outside of his/her comfort zone; Demonstrated pragmatism and willingness to drive and support change; Demonstrated ability to challenge established practices and concepts.
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