Senior Director, Clinical Development - 2359

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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 many diseases.

We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before.

Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Position Summary

The Senior Director, Clinical Development, reporting to the VP of Clinical Development will be responsible for the oversight and execution of key clinical assets in Editas’ hematology franchise. This individual will lead the design of the clinical research study protocols for all Clinical phases, while working closely with internal partners on core program teams, clinical development teams, and external stakeholders and clinical research organizations. Additionally, the Senior Director will play a key role in leading external communication with KOLs and Patient organizations, and overseeing the clinical publication strategy and execution at Editas.

Key Responsibilities

• Clinical Leadership, Oversight, and Input
  • Execution of key clinical assets in hematology franchise
    
  • Lead medical monitor for clinical studies
  • Clinical SME on study team
• Ensuring Quality Medical Science
  • Design clinical research study protocols for Phase 1 to Phase 4 studies, including rationale, study population, objectives, patient inclusion/exclusion criteria, dose selection, endpoints, sample size, safety monitoring
• Preparing Clinical Program Strategy and Regulatory Documents
  • Provide strategic medical input to disease prioritizations, target product profiles, clinical trial protocols, clinical development plans, and regulatory documents and submissions, including INDs/IMPDs, BLAs/MAAs, and expedited pathway applications;
  • Maintain clinical knowledge of treatment landscapes including current treatment strategies, current and potential competitors, and new therapeutic developments.
• Participating on Cross-Functional Teams
  • Provide medical expertise on program core teams and clinical development teams;
  • Work collaboratively with internal teams, consultants, and clinical research organizations to advance programs, management, and external stakeholders
• Leading External Communications
  • Interact with external key opinion leaders and patient organizations;
  • Moderate advisory board meetings and focus groups;
  • Oversight, input, and support across pre-clinical to clinical programs
  • Evaluation of assessment measures;
  • Interpretation of clinical trial results.
  • Oversee clinical publication strategy and execution, including giving presentations at conferences and submitting manuscripts to support company objectives.

Requirements

Knowledge, Skills & Capabilities

• Understanding of the spectrum of drug development, from IND enabling, translational through late-phase development
• Understanding of genetic concepts and molecular biology laboratory techniques; knowledge of gene therapy and orphan disease drug development is beneficial
• Familiarity with pharma/biotech clinical operations, including conduct of research collaborations and relevant regulatory and legal requirements, including ICH, GCP, and HIPAA
• Exceptional leadership capabilities to manage team members and lead a function
• Ability to work cross-functionally to influence others and promote key initiatives
• Experience interacting with clinical investigators and medical experts
• Excellent verbal, written, and interpersonal communication skills; able to clearly communicate concepts and information in writing and via formal presentations to scientific and medical experts internal and external to the company.

Education & Relevant Work Experience:

• MD or MD/PhD required with specialty board certification preferred
• Strong clinical and scientific background
• Experience with gene or cell therapy, or hematology p