Sr. Medical Director/Executive Director, Early Clinical Development (Biotech)

TL;DR

Sr. Medical Director/Executive Director (Early Clinical Development): Leading the Early Clinical Development Team, overseeing IND submissions and the design of first-in-human trials with an accent on hematology and oncology. Focus on integrating cellular therapy specifics into clinical strategies and ensuring strict regulatory compliance and patient safety.

Location: Hybrid, Somerset, NJ, United States

Salary: $294,483 - $444,486 USD

Company

Global biotechnology company developing advanced cell therapies, including CAR-T and NK cell-based immunotherapies, to treat life-threatening diseases.

What you will do

• Lead clinical science for the design, execution, and reporting of first-in-human stage clinical trials.
• Integrate PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy.
• Develop study protocols, clinical study reports, and manage medical monitoring and safety reporting.
• Collaborate with academic scientists, clinical experts, and study investigators.
• Represent the project in internal and external venues and support business development activities.
• Ensure high standards of ethics, compliance, and safety for all clinical deliverables.

Requirements

• MD or MD-PhD with US board certification in hematology and/or oncology.
• 3+ years (for Sr. Director) or 6+ years (for Executive Director) of industry/academic clinical development experience.
• Must be based in the United States.
• Proven experience in first-in-human clinical development and IND submissions.
• Strong leadership skills and ability to operate across multiple geographies in a matrix environment.
• Willingness to travel up to 15-20% of the time.

Nice to have

• Sub-specialization or clinical development experience in cell therapies or CAR-T.
• Prior experience working within the biotech industry.
• Experience leading pre-IND and IND meetings with health authorities.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Flexible spending (FSA) and health savings accounts (HSA).
• Generous paid time off policy including vacation, personal, and sick time.
• Well-being initiatives and peer-to-peer recognition programs.