Senior Medical Director, Clinical Development

Editas; Cambridge (MA); On-site; USD 345,000 - 375,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Tuition reimbursement

Paid time off

Job summary

Editas Medicine is seeking a Senior Medical Director, Clinical Development to provide medical, scientific, and operational leadership for genetic disease and gene-editing programs. You will design and oversee global trials, partnering with R&D and the CMO to drive early development decisions and portfolio strategy.

Ideal candidates bring MD/MD-PhD, 10+ years in clinical R&D, and proven ability to lead cross-functional teams, manage partnerships, and travel to global sites.

Qualifications

• 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.
• Experience designing and executing global clinical trials; gene-editing/ gene therapy exposure is a plus.
• Hands-on experience overseeing trials with CROs, investigators, and hospital partners.
• Willingness to travel to oversee global trials.
• Strong understanding of trial methodology, translational science, safety monitoring, and regulatory pathways.
• Proven ability to work in matrixed teams and influence across stakeholders.
• Excellent written and verbal communication, including presentations to regulators and governance bodies.
• Strategic, pragmatic, and thrives in a high-growth biotech environment.
• Strong network of clinical investigators and collaborators worldwide.

Responsibilities

• Lead design, medical oversight, and execution of clinical development strategies for gene-editing programs (e.g., EDIT-401) with early development focus.
• Serve as clinical program lead, ensuring high-quality execution and data integrity.
• Integrate biomarker strategy, safety monitoring, and indication rationale with R&D.
• Develop and refine clinical development plans and protocols aligned with regulatory expectations.
• Prepare clinical documents for regulatory submissions (IND, CTA, NDA/BLA) with medical rationale.
• Collaborate with regulatory affairs and regional experts for global readiness.
• Coordinate with Clinical Operations, Regulatory, PM, CMC, Analytics, and Commercial teams for integrated planning.
• Partner with Research for indication selection and biomarker development.
• Provide clinical leadership in risk assessments, data reviews, and governance forums.
• Build networks with global investigators, KOLs, and patient advocacy groups.
• Lead or support scientific advisory boards, investigator meetings, and data reviews.
• Represent the company at scientific conferences and in manuscripts and abstracts.

Education

MD or MD/PhD with cardiovascular/rare disease training

Job description

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

Why Choose Editas?

At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!

Decoding The Role:

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. With EDIT-401 approaching clinical development and a rapidly advancing pipeline, this role offers the opportunity to shape both current programs and future portfolio strategy while serving as a close partner to the research organization and CMO. Ideal candidates will thrive in a fast-paced biotech environment, combining scientific expertise, strategic thinking, and hands‑on clinical execution to drive successful program outcomes.

As the Senior Medical Director, Clinical Development you will:

• 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

The Ideal Transcript:

To thrive in this role, you’ll need:

• 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

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company‑funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Salary Range:

$345,000 - $375,000

Pay Transparency

Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.