Location:
Watertown, MA
Employment Type:
Full-Time
Salary:
Competitive
Job Description
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:
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Create clinical strategies and development plans for assigned programs in Phase I or II of development
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Provide medical input into the design of clinical trials for these programs
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Work closely with other functional areas within R&D, pre- clinical and clinical to facilitate the execution of clinical trials and programs
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Interpret clinical trial data, and work with the project team and investigators to develop scientific conclusions from clinical trial data
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Contribute to the writing review and editing of study-related documents including clinical trial protocols, clinical study reports, IND documents, presentations and manuscripts
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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
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Serve as lead medical representative with regulatory agencies
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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
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Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs
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Provide clinical, scientific and development expertise to business development initiatives as needed
Requirements
Education and Experience Requirements
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Scientific Ph.D. required, medical degree or MD preferred or internationally recognized equivalent
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Medical expertise in Rheumatology preferred
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Minimum of six years of pharmaceutical/biotech-industry experience in clinical research or clinical development, ideally with experience across all phases of clinical trials
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Possesses thorough understanding of strategic and operational aspects of clinical research and product development
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Experience in preparation of NDA’s, IND’s and other regulatory documents
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Experience interacting directly with federal regulators
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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
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Persuasive, effective and flexible in personal interactions at all levels, with strong oral and written communication capabilities
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Strong project management and problem-solving skills
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Displays sense of urgency, and a willingness to be a “player/coach” able to roll up sleeves to get the work done when necessary
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Willingness to travel up to 50% of the time
Qualified candidates should apply at http://www.companycareersite.com/lmgr.aspx?l=WB4HJCB . 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).
NO PHONE CALLS OR AGENCIES PLEASE