Executive/Senior Director, Clinical Development

Company: Sarepta Therapeutics
Location: Cambridge
Posted on: January 11, 2021

Job Description:

Executive/Senior Director, Clinical Development Cambridge, MA Reporting to the Head of Clinical Sciences, the individual in this role will work across the entire spectrum of clinical programs within Sarepta Therapeutics to provide scientific and strategic leadership for activities in clinical development, portfolio strategy, and, as needed, to support business development, including due diligence, and foster innovation and external collaboration. It is expected that this individual will play a significant role in development and portfolio strategy for new indications at Sarepta. The ideal candidate has a doctorate degree (MD and/or PhD) and proven success in clinical development through industry experience and a passion to further the Sarepta pipeline.Primary Responsibilities Include:

• Leads the design and strategy of clinical development for multiple portfolio assets
• Leads the clinical teams of multiple assets to ensure successful protocol development, protocol monitoring, study reports, training documents, and other clinical and regulatory documents
• Leads clinical development teams to facilitate clinical development goals and achievement of study quality metrics
• Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders
• Can effectively work across multiple projects within a designated therapeutic area
• Remains up to date on current information regarding regulations and guidelines for their therapeutic area and scientific advances in the relevant field both internal and external to Sarepta
• Cultivates relationships with external partners such as clinical investigators, clinicians, and scientists in support of innovation and business development
• Will assist with the due diligence process as it pertains to business development opportunities
• May require travel to field sites, internal and external meetings and conferencesEducation and Skills Requirements:
  • Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
  • Ability to make independent, timely, and risk-based decisions
  • Ability to work collaboratively in a fast-paced, team-based matrix environment
  • Excellent written and verbal communication skills
  • Intellectual curiosity, flexibility, and persistence
  • High level of organizational and project management skills
  • Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators
  • Has at least 6-8 years of clinical/research experience including 4 years of industry experience
  • Doctorate degree: D, Ph.D. or Pharm D in a related areaCandidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. Posted 30+ Days Ago Full time R-00394 About Us Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. If you are interested in an organization that is collegial, entrepreneurial and driven toward success, we invite you to apply today.

Keywords: Sarepta Therapeutics, Cambridge , Executive/Senior Director, Clinical Development, Executive , Cambridge, Massachusetts