Senior Medical Director, Clinical Development Lead
Baxter Healthcare - Illinois

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Summary: Responsible for the strategic design of clinical drug or medical device development plans and for determining and overseeing the implementation of the development strategy to optimize the potential therapeutic and commercial profile on registration and through life cycle management. Advance clinical development of product to the market. Partnering with Therapeutic Area Experts. Responsible for overseeing Phase I-IV studies and post approval commitments. Lead for a team of medical directors and medical writers. Responsible for the strategic alignment, scientific integrity and correctness of documents related to the drug/device development process. Strong experience with submissions for regulatory agencies. Essential Duties and Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. 1 Responsible for the strategy, direction, design, prioritization, and safety of clinical studies 2 Prepare global clinical development and R&D strategies. 3 Direct all clinical studies globally. 4 Prepare or supervise preparation of a clinical development strategy/plan for each project with realistic timelines. 5 Coordinate and drive clinical research programs with appropriate global and regional functions. 6 Supervise conduct of clinical studies. Manage staff to monitor clinical studies for protocol compliance, user interface with product, and accuracy of data. 7 Prepare and manage the annual clinical research budget. 8 Review and approve Standard Operating Procedures (SOPs) for conducting clinical trials in compliance with Good Clinical Practices and company policies and procedures. 9 Oversee a team of medical directors and medical writers involve in clinical development plans, clinical studies, and clinical sections of submissions 10 Oversee external vendors including research organizations, CRO's, and central laboratories in partnership with clinical project managers. 11 Lead, manage, and develop clinical research staff. 12 Collaborate with team members from therapeutic areas and within clinical development and operations.
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axter International Inc. (NYSE: BAX), is an American health care company with headquarters in Deerfield, Illinois. The company primarily...