Medical Director – Clinical Development

Employvision Inc.

United States

Hybrid

USD 250,000 - 360,000

Full time

3 days ago
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Job summary

Employvision Inc. is seeking a Medical Director – Clinical Development (CNS) in NYC, with a preference for hybrid work. The role is hands-on, focusing on trial design, safety oversight, and regulatory support for neurodegenerative programs.

You will lead Phase II/III trials, provide medical monitoring, and collaborate with cross-functional teams, CROs, and KOLs, driving scientific communication and data interpretation. Significant CNS experience and regulatory acumen are required.

Qualifications

  • MD, DO, or equivalent medical degree.
  • 10+ years of pharmaceutical or biotechnology drug development experience.
  • Experience designing and executing Phase II/III clinical trials.
  • Direct CNS disorder experience, including dementia or Alzheimer's disease.
  • Knowledge of FDA regulations, GCP, and clinical safety requirements.
  • Strong scientific communication and cross-functional collaboration skills.

Responsibilities

  • Design and support Phase II/III trials, including protocols, endpoints, timelines, and execution strategies.
  • Provide medical oversight for studies, including safety reviews and data interpretation.
  • Support drug safety surveillance, AE reporting, and DSMB activities.
  • Contribute to regulatory submissions, study reports, and regulatory responses.
  • Collaborate with clinical operations, investigators, CROs, and KOLs.
  • Support development strategies, trial budgets, publications, and medical communications.

Skills

Medical leadership
Cross-functional collaboration
Regulatory knowledge
Clinical data interpretation
Strategic planning

Education

MD/DO or equivalent

Job description

Medical Director – Clinical Development (CNS)

NYC - Preferably hybrid

We are seeking an experienced Medical Director – Clinical Development to support clinical programs focused on neurodegenerative disorders, particularly Alzheimer's disease and Dementia with Lewy Bodies (DLB).

This is a hands-on medical and clinical development role focused on clinical trial design, execution, safety oversight, and regulatory support, working closely with cross-functional teams and external clinical experts.

Key Responsibilities
  • Design and support Phase II/III clinical trials, including protocols, study endpoints, timelines, and execution strategies.
  • Provide medical oversight for clinical studies, including medical monitoring, safety reviews, and interpretation of clinical data.
  • Support drug safety surveillance, adverse event reporting, and Data Safety Monitoring Board (DSMB) activities.
  • Contribute clinical expertise to regulatory submissions, study reports, and responses to regulatory agency inquiries.
  • Collaborate with clinical operations teams, investigators, CROs, and Key Opinion Leaders (KOLs).
  • Support clinical development strategies, trial budgets, scientific publications, and medical communications.
Required Qualifications
  • MD, DO, or equivalent medical degree.
  • 10+ years of pharmaceutical or biotechnology drug development experience.
  • Strong experience designing and executing Phase II/III clinical trials.
  • Direct experience in CNS disorders, particularly dementia or Alzheimer's disease.
  • Knowledge of FDA regulations, Good Clinical Practice (GCP), and clinical drug safety requirements.
  • Strong scientific communication, analytical, and cross-functional collaboration skills.
Preferred Qualifications
  • Experience supporting NDA submissions and late-stage clinical development.
  • Experience with pharmacovigilance, regulatory interactions, and clinical data interpretation.
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