Director/Senior Director, Clinical Development
Editas Medicine, United States

Motivated clinical development professional interested in translating cutting edge early platform science to clinic.

Key Responsibilities amp; Accountabilities:

• Clinical Leadership, Oversight, and Input
  • Execution of key clinical assets as in hematology and opthalmalogy franchises
• Ensuring Quality Medical Science
  • Design clinical research study protocols for Phase 1 to Phase 4 studies, including objectives, patient inclusion/exclusion criteria, dose selection, endpoints, sample size, and 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 amp; 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 amp; Relevant Work Experience:

• MD or MD/PhD with specialty board certification preferred
• Strong clinical and scientific background
• Experience with gene therapy or cell therapy, preferred
• 3-5 years of pharmaceutical or biotechnology industry experience in clinical drug development; experience designing and running clinical trials and interacting with regulatory authorities.
• Regulatory experience, including interactions with FDA/EMA and submitting INDs/IMPDs and NDAs/BLAs/MAAs

Physical amp; Travel Requirements:

• Business-related travel ~ 10%

Job Rewards and Benefits