Sr Director, Clinical Pharmacology Job in Edison 08817, New Jersey Us
Job Summary: We are currently seeking a Senior Director, Clinical Pharmacology for our Edison, New Jersey location. This position develops and directs the clinical pharmacology programs and studies for therapeutic area product(s) within Daiichi Sankyo Pharma Development. Will be capable of representing Translational Medicine and Clinical Pharmacology Department on an Integrated Product Development Team. Will be responsible for the clinical pharmacology portions of an Integrated Development Plan. Will design clinical pharmacology studies and in conjunction with Study Logistics be responsible for protocol development, study implementation, analysis and reporting of results for a product. Will be responsible for clinical pharmacology sections of Investigator Brochures, IND, CTD and other regulatory submissions.In addition, will supervise or mentor junior Clinical Pharmacologists working in related areas. Responsibilities: In this role, you will represent the Clinical Pharmacology and Pharmacokinetics Department within the Integrated Project Teams (IPTs) and Regional Project Teams (RPT). Coordinate the clinical pharmacology program for specific medications with other departments, e.g., clinical development, biostatistics, project management, CMC, regulatory, safety and legal.Develop clinical pharmacology plans, design and direct clinical pharmacology studies. Work with Study Logistics, CROs and other vendors to execute clinical pharmacology studies. Review results and reports. If medically qualified, also responsible for medical review of additional TM/CP projects, including assessment of subject risk/benefit. Present results, interpretations and recommendations at the IDT and Regional Project Teams. Prepare and/or review clinical pharmacology sections of investigator brochures, regulatory documents, and external presentations and publications. Represent Clinical Pharmacology during interactions with regulatory agencies.Manage junior Clinical Pharmacologist(s) working in related areas.Develop and review project budgets.Assist with coordination of key opinion leaders, consultants and other therapeutic area specialists in the drug development process. Senior director will be expected to identify and develop relationships with key opinion leaders and other experts.Active participation in task forces to develop new local and global business processes.Assist in the orientation of new hires and on-going training of in-house employees and contractors. Education/Experience Qualified candidates must have a M.D., Ph.D. or equivalent degree.Senior Director will have at least 5 years experience in pharmacokinetics and at least 5 years relevant pharmaceutical industry experience.At least 2 years supervisory experience required for Senior Director level.Excellent verbal written communications skills; Good interpersonal skills; Good working knowledge of statistics.Thoroughly understand the pharmaceutical science landscape and optimizes that knowledge to better the drug research and development process (technical thought leadership.)Must be willing to travel 20% of the time.
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