Medical Director, Clinical Development (Gene Therapy)

Location: Cambridge, Massachusetts, United States. Travel to investigator sites, regulatory meetings, and conferences is required, up to 25%.

Salary: $272,000–$302,000 USD annual base salary, plus eligibility for annual short-term and long-term incentive awards.

Company

Biotechnology company developing Prime Editing gene therapies designed to precisely correct genetic mutations across multiple tissues and disease areas.

What you will do

• Develop clinical trial strategies for the safe and efficient introduction of gene editing therapeutics into human studies.
• Conceptualize and author observational and interventional clinical trial protocols from Phase I through Phase IV.
• Serve as medical monitor by overseeing patient safety, interfacing with investigators, and analyzing clinical trial data.
• Represent clinical development on cross-functional program teams and collaborate with research, clinical sciences, regulatory affairs, and clinical operations.
• Organize Scientific Advisory Boards, engage Key Opinion Leaders, and represent the organization in regulatory interactions.
• Implement translational biomarker programs, analyze translational data, and support scientific and medical conference activities.

Requirements

• M.D. or equivalent degree; M.D.-Ph.D. preferred.
• At least 3 years of industry or equivalent academic experience overseeing clinical trials or conducting relevant research.
• Strong understanding of gene therapy, genetics, and immunology, with broad medical knowledge and ability to work with novel medical concepts.
• Basic understanding of Good Clinical Practice and familiarity with standard statistical methodologies and analytical tools.
• Strong written and verbal communication skills, including scientific publications and oral presentations.
• Ability to work effectively in a heavily matrixed, cross-functional environment.

Nice to have

• Specialization in pulmonology or hepatology.
• M.D.-Ph.D. degree.

Culture & Benefits

• Comprehensive health, financial, and wellness benefits, including medical, dental, vision, and life insurance.
• 401(k) matching and equity programs.
• Generous paid time off, wellness days, and company-wide recharge breaks.
• Annual short-term incentive and long-term incentive awards.