Ruderfer & Associates
Biopharmaceutical Search Consultants

#2106

Senior/Executive Medical Director, Clinical Research (Sleep)

Position:                     Sr./Executive Medical Director, Clinical Research (Sleep)         #2106 

Location:                     Northern, NJ

Compensation:          Based upon Experience

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Job Summary
 
The Senior Medical Director/Executive Medical Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Sleep Disorders therapeutic area. 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. 

Duties & Responsibilities:

  • 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

  • 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 contractors 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 at the company

  • Participating in the recruitment, selection, performance, and succession planning activities 

Qualifications:

  • MD required, Board Certification in a related area preferred.

  • Sr. Medical Director requires: 10+ years in pharmaceutical clinical development, with experience directing Neurology Phase 2-3 global multicenter studies

  • Executive Medical Director requires: 12+ years in pharmaceutical clinical development with experience directing Neurology Phase 2-3 global multicenter studies

  • Experience in Sleep Disorders within 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.

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