Senior Medical Director, Neurology

The businesses of Merck KGaA, Darmstadt, GermanyBillerica, MA
162d

About The Position

You will oversee specific medical aspects within Global Clinical Development for the Neurology Therapeutic Area, providing overall clinical and scientific leadership for a neuroinflammation program, including responsibility for clinical development strategy and execution of clinical trials. You will provide medical and clinical guidance for the Global Development Neurology therapeutic team, plan, guide and manage clinical trials, aiding study design and interpretation of results. You will provide scientific input and drive concept sheets, protocols, briefing books and regulatory interactions, investigator brochures, study reports and publications. You will lead multi-disciplinary teams in a success-driven matrix environment, manage internal and external stakeholders and mentor and work along Clinical Scientists towards high-quality execution of agreed clinical development strategy.

Requirements

  • Medical Degree (MD) or international equivalent
  • 7+ years of clinical Neurology experience in academia or industry, including hands-on acute neurological care
  • 5+ years of medical leadership experience in a pharmaceutical or biotechnology industry and regulatory submissions and interactions (i.e. FDA, EMA and others)
  • Deep understanding of clinical development programs and drug development processes
  • Experience in designing clinical development plans and clinical studies, setting up and execution of clinical trials, leading cross-functional teams, globally
  • Up to date knowledge of GCP, ICH, US FDA and EMA regulations
  • Able to effectively partner with Global Program Head and Program Strategy Team for a given asset and multiple Global functions (Safety, Operations, Biostats, Regulatory, Quality Assurance, Medical Affairs and Business Franchise)
  • Excellence in development strategy and operational implementation, highly skilled in problem solving, track record of meeting milestone deliveries under tight deadlines
  • Excellent communication, collaboration, and leadership skills
  • Ability to work collaboratively and seamlessly in intense, fast paced, multinational work environment

Nice To Haves

  • Board Certification in Neurology and/or advanced scientific degree (MD/PhD)

Responsibilities

  • Oversee specific medical aspects within Global Clinical Development for the Neurology Therapeutic Area
  • Provide overall clinical and scientific leadership for a neuroinflammation program, including responsibility for clinical development strategy and execution of clinical trials
  • Provide medical and clinical guidance for the Global Development Neurology therapeutic team
  • Plan, guide and manage clinical trials, aiding study design and interpretation of results
  • Provide scientific input and drive concept sheets, protocols, briefing books and regulatory interactions, investigator brochures, study reports and publications
  • Lead multi-disciplinary teams in a success-driven matrix environment
  • Manage internal and external stakeholders
  • Mentor and work along Clinical Scientists towards high-quality execution of agreed clinical development strategy

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

Ph.D. or professional degree

Number of Employees

5,001-10,000 employees

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