Executive Director Clinical Research (Medical Director)
Job Location: Northern NJ
Pharmaceutical/Biotech, North NJ
Excellent base salary plus bonus, LTI, full relocation available if needed.
The Executive Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Neurology therapeutic areas. Dependent upon specific projects or compounds, the incumbent may function as an International Project Team Leader. It is essential that qualified individuals possess Medical Doctor credentials.
Responsibilities include but are not limited to:
Designing and providing insight of clinical research plans and programs to include the integrated regulatory and biomarker strategies. Leading the development and execution of the CDP and DDP. Leading the development of Clinical Protocols to meet CDP objectives. Overseeing and resolving operational aspects of clinical studies in conjunction with project and study teams and in accordance with SOP, GCP and regional regulations. Reviewing and Monitoring safety data from a clinical program and identifying trends and signals. Developing strategies to identify, monitor and resolve clinical program/trial issues. Serving as SME to management for the (marketing or research functions) and regulatory agencies, sets strategy for Advisory Boards, and builds strong relationships with KOLs. Interpreting study data and developing integrated summaries of safety and efficacy. Providing scientific leadership for regulatory documents creation (e.g., briefing books, NDAs etc.). Representing Clinical in discussions with Health Authorities- Participating in selection of new compounds for clinical development and IND filing in neuroscience through technical evaluation of licensing and/or partnering opportunities. Integrating and implementing new resources (tools, systems, vendors, etc.) and techniques with existing ones. Setting overall deadlines for projects within function and tracking project milestones. Managing contractions or ensuring that contractors, consultants and vendors complete assigned work according to agreed timelines. Making appropriate budgetary allocations to targeted opportunities. Championing effective coaching and development planning in a way that fosters a culture of proactive people in development within the company. Participating in the recruitment, selection, performance, and succession planning activities.
MD required, board certified preferred. 10+ years of experience in pharmaceutical clinical development, with - experience directing Neurology Phase 2-3 global multicenter studies. Experience in Neurology, Epilepsy or Alzheimer’s Clinical Development a plus. A thorough understanding of clinical research methodology including study design, protocol writing and study report preparation. Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience. Knowledge of medical, scientific and clinical research techniques in the Neurology area.
Please contact Darren Gutowski at firstname.lastname@example.org
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