Senior Director
Clinical Development
Posted on 2/2/2023
Cambridge, MA, USA
Experience Level
Desired Skills
Google Cloud Platform
  • 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
  • MD or MD/PhD required with specialty board certification preferred
  • Strong clinical and scientific background
  • Experience with gene or cell therapy, or hematology 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
  • Business-related travel ~ 10%
  • 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
Editas Medicine

51-200 employees