Position:  Medical Director, Clinical Development & Medical Affairs
Location:  Cambridge, MA
Job Id:  023
# of Openings:  1

The Associate Director/Director of Clinical Development & Medical Affairs will work in a fast-paced and stimulating environment with dynamic and dedicated colleagues focused on leveraging state-of-the-art science to solve Duchenne muscular dystrophy (DMD).This position resides within the medical/clinical operations/regulatory team led by Solid’s Chief Medical Officer and reports to the Vice President, Clinical R&D. The Associate Director/Director will primarily support clinical development efforts along with some medical affairs activities related to Solid’s research and development initiatives in DMD. This role will interface cross-functionally with R&D, regulatory, clinical, CMC, and communications colleagues within Solid as well as externally with clinical research organizations, advocacy groups, industry consortia and scientific thought leaders in DMD. The emphasis in this role is on clinical development but physicians with a pharma/biotech medical affairs background may also be considered.
Key Duties & Accountabilities:
  • Provide medical support for clinical development activities including:
    • Review and analysis of safety and other study data
    • Interactions with contract research organizations and other study vendors via study team meetings and ad-hoc interactions
    • Preparation of clinical and regulatory documents such as protocols, investigator brochures, informed consent/assent forms, and medical sections of regulatory submissions and updates
    • Answer study-related questions from sites and other study partner
  • Perform internal and external medical affairs activities according to the needs of the organization
    • Represent Solid at scientific/medical/advocacy conferences and develop strong relationships with scientific, medical, and advocacy leaders in DMD
    • Serve as informational resource regarding disease state and Solid’s pipeline programs
    • In collaboration with Solid communications and competitive intelligence colleagues, track and summarize key publications and competitive intelligence in the Duchenne field
    • Provide medical input regarding conference coverage and scientific publications strategy via cross-functional discussion with internal stakeholders across the medical, R&D and communications teams
  • Help develop and review Solid scientific/medical abstracts and manuscripts as needed
  • Provide medical input and direction for Solid pipeline programs including evaluation of safety/benefit-risk, target product profile, clinical development plan and clinical trial design
  • Assist with medical due diligence as needed to evaluate new product opportunities and alliances
Education, Experience & Skills:
  • Strong leadership and collaboration skills with the ability to work effectively with external thought leaders and clinical trial partners as well as internal colleagues across different functions within Solid
  • Superior verbal and written communication skills; able to communicate effectively with both scientific and non-scientific audiences
  • Able to understand and act according to good communications practices and interact with internal and external parties with tact and sensitivity
  • Detail-oriented, self-motivated with the ability to work independently
  • Able to critically evaluate scientific and clinical data
  • Required:
    • MD, DO, or equivalent degree with clinical experience in neurology, pediatrics and/or rare/genetic diseases; MD/PhD ideal
    • 2+ years of industry experience in clinical development and/or medical affairs (strong clinical development background preferred)
  • Preferred:
    • Experience conducting clinical trials in an industry setting
    • Background in Duchenne muscular dystrophy/neuromuscular diseases
  • Up to 20%

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