Sr. Medical Director, Clinical Operations and Research



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

Qualified candidates should apply at SRMDDIR.  Please refer to Job Code 17004 when corresponding about this position.

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


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