• Full Time (Salaried)
  • Remote,

Company:  Confidential

Job Title: VP Clinical Development

Job Number: 34426

Location: Remote, 

Job Description

Responsibilities

  • Lead the development of strategic scientific and medical input into clinical research programs and individual clinical trials
  • Collaborate with company Global Clinical Research teams to drive scientific content of protocols, clinical study reports, clinical investigator brochures, briefing books, orphan drug applications and other documents
  • In conjunction with Contract Research Organization (CRO) personnel, lead medical oversight of clinical research programs, including medical monitoring, safety evaluations, protocol deviations, and other required activities
  • Develop and maintain bank of external key opinion leaders and consultants related to company projects
  • Oversee and drive strategic statistical input into clinical research programs
  • Prepare and deliver scientific and medical presentations for key opinion leaders, regulatory authorities, and internal groups
  • Lead production of primary manuscript publications from completed clinical trials
  • Lead development and strategy team focused on cutting edge scientific and medical input
  • Maintain current knowledge of strategic trial design and data generation to include registries and real-world data generation in support of registration programs 
  • Represent company at key external scientific congresses, advisory boards, etc

  • Interacts internally with Global Clinical Research and Operations, Quality, Regulatory Affairs, Pharmacovigilance, Research and Development, Global Commercial, and Medical Affairs team members
  • External interactions include key opinion leaders, external regulatory agencies, consultants

Required Skills

  • Advance degree in medical, pharmacy, or relevant scientific field (MD,

  • PharmD, PhD). Health sciences related degree preferred

  • Proven experience (15+ years) in industry clinical research trial design and execution

  • Demonstrated experience interacting with global regulatory agencies (FDA,EMA, MHRA, etc.)

  • Excellent written and verbal communication skills

  • Documented personnel management experience

  • Familiarity with regulatory guidelines (e.g., Good Clinical Practice, ICH, FDA,EMA guidelines, etc.)

  • Attention to detail, strong organizational skills, and the ability to manage multiple projects and deadlines effectively

  • Collaborative and adaptable team leader who can work effectively in a fast-paced, cross-functional environment

  • Based in the US

  • Willingness/ability to travel domestically and internationally when required

 

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