Senior Medical Director, Clinical Development
Editas Medicine
Summary
The Senior Medical Director, Clinical Development will provide medical, scientific, and operational leadership for clinical programs focused on genetic diseases and gene-editing therapeutics, with an emphasis on early-stage and proof-of-concept studies. Reporting to the Chief Medical Officer, this physician-scientist will lead the design, execution, and optimization of global clinical trials, including the establishment and oversight of sponsor-led studies and the management of key academic and operational partnerships.
Job description
Responsibilities
- Lead the design, medical oversight, and operational execution of clinical development strategies for EDIT-401, with emphasis on early development (FIH, Phase 1–2) and translational endpoints relevant to gene editing.
- Serve as clinical program lead, providing day-to-day medical and scientific leadership to ensure high-quality clinical execution and data integrity.
- Partner closely with R&D to integrate biomarker strategy, safety monitoring approaches (e.g., immunogenicity, off-target assessments), and indication rationale.
- Contribute to the development and refinement of clinical development plans and study protocols, ensuring alignment with global regulatory expectations.
- Support preparation of clinical documents for regulatory submissions (IND, CTA, NDA/BLA components, study reports), with specific focus on medical content and scientific rationale.
- Collaborate with regulatory affairs and region-specific experts to ensure readiness for interactions with global regulatory agencies.
- Work closely with Clinical Operations, Regulatory, Project Management, CMC, Analytical Sciences, and Commercial to ensure integrated planning and execution.
- Partner with Research teams on indication selection, biomarker development, and advancing new pipeline programs.
- Provide clinical leadership in cross-functional forums, risk assessments, data reviews, and stage-gate processes.
- Cultivate strong networks with global investigators, KOLs, and patient advocacy groups.
- Lead or support scientific advisory boards, investigator meetings, and data-review interactions.
- Represent the company at scientific conferences and contribute to manuscripts, abstracts, and presentations.
Requirements
- MD or MD/PhD with training in cardiovascular diseases, internal medicine, rare disease, or related fields.
- 10+ years of industry experience in clinical research and development, including leadership of early-stage cardiovascular disease and/or rare disease programs.
- Demonstrated experience designing and executing global clinical trials; experience with gene-editing, gene therapy, or advanced modalities is a plus.
- Hands-on experience establishing or overseeing clinical trials, including collaboration with local CROs, investigators, and hospital partners.
- Willingness to travel to develop and oversee global clinical trials.
- Strong understanding of clinical trial methodology, translational science, safety monitoring, and global regulatory pathways.
- Proven ability to work effectively in matrixed teams and influence across scientific, operational, and business stakeholders.
- Exceptional written and verbal communication skills, including experience presenting to investigators, regulators, and internal governance bodies.
- Strategic, pragmatic, and able to thrive in a high-growth, mission-driven biotech environment.
- Strong network of clinical investigators and scientific collaborators globally, enabling effective partnership-building, and study execution.
Requirements
- MD or MD/PhD with training in cardiovascular diseases, internal medicine, rare disease, or related fields.
- 10+ years of industry experience in clinical research and development, including leadership of early-stage cardiovascular disease and/or rare disease programs.
- Demonstrated experience designing and executing global clinical trials; experience with gene-editing, gene therapy, or advanced modalities is a plus.
- Hands-on experience establishing or overseeing clinical trials, including collaboration with local CROs, investigators, and hospital partners.
- Willingness to travel to develop and oversee global clinical trials.
- Strong understanding of clinical trial methodology, translational science, safety monitoring, and global regulatory pathways.
- Proven ability to work effectively in matrixed teams and influence across scientific, operational, and business stakeholders.
- Exceptional written and verbal communication skills, including experience presenting to investigators, regulators, and internal governance bodies.
- Strategic, pragmatic, and able to thrive in a high-growth, mission-driven biotech environment.
- Strong network of clinical investigators and scientific collaborators globally, enabling effective partnership-building, and study execution.
Benefits
- Blue Cross Blue Shield PPO Medical Plan
- Health Savings Account
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Dependent Care Account
- Tuition Reimbursement
- 401(k) plan with company match
- Employee Assistance Plan
- Wellness Programs
- Paid Time Off
Company overview
Editas Medicine is a pioneering clinical-stage biotechnology company focused on developing transformative genomic medicines using CRISPR gene editing technology. Founded in 2013 and headquartered in Cambridge, Massachusetts, the company translates the power of CRISPR/Cas9 and CRISPR/Cas12a genome editing systems into a robust pipeline of in vivo medicines for serious diseases. Editas aims to discover, develop, manufacture, and commercialize durable, precision gene editing therapies for a broad class of genetic disorders. The company's innovative platform enables targeted editing of disease-related genes inside the body, with current programs targeting conditions such as sickle cell disease, beta-thalassemia, Leber congenital amaurosis, and cardiovascular diseases. As a publicly traded company on NASDAQ (EDIT), Editas has established strategic partnerships with leading pharmaceutical companies and maintains exclusive licensing agreements with prestigious research institutions including the Broad Institute and Harvard University for key CRISPR technology patents.