Selecta Biosciences
  • Watertown, MA, USA
  • Full Time

Sr. Medical Director, Clinical Operations and Research

NO PHONE CALLS OR AGENCIES PLEASE.

Summary:    

Selecta Biosciences is seeking a talented, highly motivated Sr. Medical Director of Clinical Operations & Research to join our fast-paced growing company. The primary responsibility will be to provide medical expertise and leadership necessary to advance one or more of the Company's clinical programs through Phase I and II clinical trials. Reporting to the Chief Medical Officer, the Sr. Medical Director of Clinical Operations & Research will be responsible for designing, planning, and implementing clinical programs and study protocols for Selecta's targeted immunotherapies and vaccines that are in Phases I and II of development.

 Principal Duties/Responsibilities:    

  • Create clinical strategies and development plans for assigned programs in Phase I or II of development
  • Provide medical input into the design of clinical trials for these programs
  • Work closely with other functional areas within R&D, pre- clinical and clinical to facilitate the execution of clinical trials and programs
  • Interpret clinical trial data, and work with the project team and investigators to develop scientific conclusions from clinical trial data
  • Contribute to the writing review and editing of study-related documents including clinical trial protocols, clinical study reports, IND documents, presentations and manuscripts
  • Serve as a medical monitor for clinical studies (provide medical oversight of the study;  answer questions about eligibility; review safety and adverse event information), work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget
  • Serve as lead medical representative with regulatory agencies
  • Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from safety and efficacy trials; assist in generating the study reports and publications from these trials
  • Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs
  • Provide clinical, scientific and development expertise to business development initiatives as needed

Education and Experience Requirements

  • Scientific Ph.D. required, medical degree or MD preferred or internationally recognized equivalent
  • Medical expertise in Rheumatology preferred
  • Minimum of six years of pharmaceutical/biotech-industry experience in clinical research or clinical development, ideally with experience across all phases of clinical trials
  • Possesses thorough understanding of strategic and operational aspects of clinical research and product development
  • Experience in preparation of NDA's, IND's and other regulatory documents
  • Experience interacting directly with federal regulators
  • Excellent ability to lead and work in cross-functional teams with a collaborative style that emphasizes integrity, results, and effective teamwork in a fast-paced and changing environment
  • Persuasive, effective and flexible in personal interactions at all levels, with strong  oral and written communication capabilities
  • Strong project management and problem-solving skills
  • Displays sense of urgency, and a willingness to be a "player/coach" able to roll up sleeves to get the work done when necessary
  • Willingness to travel up to 50% of the time

Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).

NO PHONE CALLS OR AGENCIES PLEASE

Selecta Biosciences
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