Associate Director Position Profile – Clinical Pharmacology Oncology
Support oncology drug development by providing clinical pharmacology / DMPK expertise across early and full development phases, and global medical affairs. Represent Oncology Clinical Pharmacology (OCP) global line function on cross-functional teams and influence design, execution, and analysis of clinical pharmacology / DMPK related study components.
1) Contributes expert pharmacokinetic / DMPK input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, IND / IMPD’s and NDA’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager. 2) Designs clinical pharmacology strategy for assigned program and coordinates pharmacokinetic / DMPK related elements for preclinical and/or clinical projects. Identifies potential project hurdles, suggests solutions and establishes contingency plans. Represents OCP on Global Program Team(s) or early project teams. 3) Performs or oversees PK and PK / PD analyses using a variety of tools and Language Position Purpose
approaches. Integrates, interprets and reports data to project teams and other customers. 4) Ensures constructive collaboration within drug development teams (GPTs, etc) and with other internal partners (e.g. DMPK, Toxicology, Modeling and Simulation, Formulations, Drug Regulatory Affairs, Clinical Development). 5) Defines and updates as appropriate the PK, PK/PD, DMPK biopharmaceutical and M&S requirements in the OCP and/or preclinical project development plans. 6) Monitors study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools (e.g. Succeed). Assures rapid and effective communication of data to project teams. 7) Leads or participates in OCP or project sub-teams. Coordinates with appropriate sub-team members and/or prepares summary documentation. 8) Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance). May act as technical subject matter expert in key clinical pharmacology / DMPK related area. 9) Attends meetings with external parties including investigators, outside experts, and health authorities. 10) May manage one or more junior OCP associates. Coaches and mentors other OCP associates.
Ph.D. in pharmacokinetics, drug metabolism or a related discipline, or a Pharm. D. with appropriate post-doctoral training
- 6 - 10 years of relevant post-doctoral, academic, industry or government experience • Expert knowledge of related disciplines (e.g. DMPK, toxicology, regulatory) and the drug development process • Demonstrated experience using in silico analysis tools (e.g. WinNonlin, SAS, NonMEM, Trial Simulator, GastroPlus, SymCyp) • Demonstrated experience and ability to work successfully as part of cross functional team in a highly dynamic, matrixed, project team environment • Excellent oral and written communication skills • Strong organizational and project skills • Expert critical thinking and problem solving skills including publications / presentations. • Strong influencing and negotiating skills • Coaching, mentoring, and people management skills
Fluent English (oral and written) Key Performance Indicators Education Experience
Send CV to: [email protected]