Clinical Development Lead (Director/VP)

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!

This role is to help advance our lead in vivo development candidate, EDIT-401, a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is very excited by the potential of this experimental treatment which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates. If you are a candidate excited to help push the boundaries of what’s possible in medicine, apply now.

Decoding The Role:

As the Clinical Development Lead, you will provide medical and scientific input to preclinical and clinical stage assets. You will take responsibility for clinical development in cross-functional teams to support early phase clinical development activities. These include the creation of overall clinical development plans and clinical study design as well writing protocols, key study and health authority documentation, medical monitoring oversight and ensuring timely delivery of studies, all in close collaboration with internal and external partners.

Characterizing Your Impact:

As the Clinical Development Lead, you will:

• Lead development efforts for assets post-candidate selection through first in human trials, including Ph 1/2 translational strategy for proof of mechanism studies and proof of concept studies in human.
• Facilitate the development of key internal and external documents pertaining to product development including clinical study protocol, informed consents, investigators’ brochure, study reports, strategy documents and project plans.
• Serve as medical lead for regulatory communication, regulatory submission documents, preparation of written responses to regulatory agency questions and response to ethics committee queries
• Proactively detect risks and analyze emergent issues during early clinical drug development and develop and implement mitigating strategies.
• Provide guidance in the medical strategy and clinical/disease expertise to Research, Translational Organization, CMC and Commercial colleagues as part of a cross functional team.
• Provide medical and scientific oversight of clinical trials, ensuring the highest standards of safety, compliance and scientific rigor.
• Take active role during study execution specifically clinical study start up, including vendor selection and oversight, site identification and selection, site and PI engagement strategy and activities.
• Provide medical leadership for safety oversight committees ensuring medical accuracy, regulatory compliance, protocol compliance and patient safety. 
• Develop and maintain relationships with KOLs and investigators, develop a broad network of experts in the cardiovascular and gene editing space.
• Collaborate with external vendors and represents Editas to external partners, including Investigators, key external experts and patient advocacy groups.
• Closely follow medical developments within in vivo gene editing / lipid nanoparticle delivery and disseminate new information within the program team and the wider organization.
• Work closely with discovery teams to provide input on the next generation of targets in the field and lead the development of early clinical study plans.

• Collaborate with external vendors and represents Editas to external partners, including Investigators, key external experts and patient advocacy groups.

Requirements

The Ideal Transcript:

To thrive in this role, you’ll need:

Qualifications:

• An advanced degree in medicine (i.e., M.D. or D.O. or equivalent). Cardiovascular and/or gene therapy preferred.
• A minimum of 5 years of relevant clinical research experience in academia or industry.
• Pharmacovigilance experience preferred although not required
• Exp