Medical Director – Clinical Development

Employvision Inc.; United States; Ibrido; USD 210.000 - 250.000; Tempo pieno

Descrizione del lavoro

Employvision Inc. is seeking an experienced Medical Director - Clinical Development (CNS) to lead neurodegenerative program work in a hands-on role in NYC, with a preference for hybrid work.

You will drive trial design, safety oversight, and regulatory support across cross-functional teams and external experts. The ideal candidate holds an MD/DO, with 10+ years in drug development, and strong CNS disease experience, including dementia or Alzheimer's.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Clinical trial design

Regulatory knowledge

Cross-functional collaboration

Medical monitoring

Pharmacovigilance

Analytical skills

Medical communications

Formazione

MD/DO or equivalent

Descrizione del lavoro

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.