Executive Director, Pipeline Clinical Lead (Biotech)

TL;DR

Executive Director, Pipeline Clinical Lead (Biotech): Leading the scientific and medical direction of early-stage clinical programs with an accent on cell and gene therapy development. Focus on designing and executing clinical trials from first-in-human through proof-of-concept, managing regulatory interactions, and driving cross-functional strategy in a fast-paced environment.

Location: Must be based in Somerset, NJ (Hybrid role)

Salary: $294,483–$386,511 USD

Company

A global biotechnology company developing advanced cell therapies to treat and cure life-threatening diseases.

What you will do

• Serve as clinical science lead for early-stage programs, overseeing study design, execution, and data interpretation.
• Define clinical strategies including PK/PD, biomarkers, and translational approaches for cell and gene therapies.
• Lead IND preparation, regulatory submissions, and interactions with health authorities.
• Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Manufacturing.
• Provide direct line management and mentorship to Medical Directors and clinical research staff.
• Represent clinical programs in internal governance and external forums with investigators and KOLs.

Requirements

• MD or MD/PhD (or equivalent) with US board certification or international equivalent.
• Minimum 8 years of clinical development experience in industry or academia.
• Demonstrated leadership in hematology/oncology clinical trials.
• Proven experience with IND submissions and health authority interactions.
• Ability to work in a hybrid capacity based in Somerset, NJ.
• Strong scientific judgment and ability to lead geographically distributed teams in a matrix environment.

Nice to have

• Cell therapy and/or CAR-T clinical development experience.
• Experience with BLA/MAA filings.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match vesting on day one.
• Eight weeks of paid parental leave after three months of employment.
• Generous paid time off policy including vacation, personal, sick, and floating holidays.
• Additional benefits including life insurance, disability coverage, and family planning resources.