Director/Senior Director, Clinical Development

Director/Senior Director, Clinical Development

Location: New Jersey

Employment Type: Full-Time

Function: Clinical Development

Position Overview

A clinical-stage biopharmaceutical company is seeking an experienced Director or Senior Director of Clinical Development to provide medical and scientific leadership across its oncology portfolio.

This individual will lead the strategy, design, execution, and interpretation of clinical trials while collaborating with cross-functional teams to generate high-quality clinical data supporting product development, regulatory submissions, and broader business objectives.

Key Responsibilities

• Lead the design and execution of clinical development programs based on medical, scientific, regulatory, and commercial objectives.
  
  
• Provide strategic medical input throughout the product lifecycle, from early clinical development through Phase 3.
  
  
• Oversee the medical integrity, quality, and execution of clinical trials.
  
  
• Partner with Clinical Operations to support patient enrollment, study timelines, and key development milestones.
  
  
• Monitor clinical safety in collaboration with Pharmacovigilance and Safety teams, including oversight of serious adverse event reporting.
  
  
• Lead or contribute to clinical documents, including protocols, Investigator's Brochures, Clinical Study Reports, regulatory submissions, and health authority response packages.
  
  
• Serve as the medical lead for cross-functional clinical study teams.
  
  
• Represent Clinical Development during regulatory interactions and external scientific discussions.
  
  
• Ensure compliance with GCP, pharmacovigilance requirements, internal procedures, and applicable global regulations.
  
  
• Provide clinical expertise for assigned compounds and oncology indications.
  
  
• Build relationships with investigators, external experts, and key opinion leaders to inform clinical strategy and protocol development.
  
  
• Maintain current knowledge of oncology research, clinical practice, competitive developments, and evolving regulatory expectations.

Qualifications

• M.D. or equivalent medical degree. International medical degrees will be considered.
  
  
• At least two years of medical monitoring experience supporting oncology clinical trials.
  
  
• Phase 1 and Phase 2 oncology experience required. Phase 3 experience preferred.
  
  
• Previous experience within a biotechnology or pharmaceutical clinical development organization.
  
  
• Demonstrated experience overseeing clinical trial safety and interpreting medical and safety data.
  
  
• Experience supporting the development of biologic oncology therapies, including antibody-based or immuno-oncology programs, strongly preferred.