Medical Director, Clinical Operations & Research
NO PHONE CALLS OR AGENCIES PLEASE
Selecta Biosciences is seeking a talented, dedicated, and enthusiastic candidate to join our clinical team! The primary responsibility of the Medical Director of Clinical Operations & Research will be to provide medical expertise and leadership necessary to advance one or more of the Company’s clinical programs through Phase 1 - 3 clinical trials. Reporting to the Head of Clinical Development (HCD), the position will be responsible for designing, planning, and implementing clinical programs and study protocols for Selecta’s programs.
- In consultation with the HCD, create clinical strategies and development plans for assigned clinical programs
- 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
- Lead contributor on regulatory documents
- 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
- Medical degree (MD) required or internationally recognized equivalent
- Medical expertise in rare diseases preferred
- Minimum of two 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
The level of this position will be based on the final candidate's qualifications.
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance technology (ImmTOR) platform. Selecta plans to combine ImmTOR with a range of biologic therapies for rare and serious diseases that require new treatment options due to high immunogenicity. The company’s current proprietary pipeline includes ImmTOR-powered therapeutic enzyme and gene therapy product candidates. SEL-212, the company’s lead product candidate, is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s proprietary gene therapy product candidates are in preclinical development for certain rare inborn errors of metabolism and incorporate ImmTOR with the goal of addressing barriers to repeat administration. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com.
NO PHONE CALLS OR AGENCIES PLEASE
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).