Medical Director/Senior Medical Director, Clinical Development at Agios Pharmaceuticals in CAMBRIDGE, MA

Job description

Medical Director/Senior Medical Director, Clinical Development Who we are: At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have built. To learn more, visit www.agios.com and follow Agios on LinkedIn and X . The impact you will make: Agios Pharmaceuticals is searching for a dynamic Medical Director / Senior Medical Director to join our clinical development team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Medical Director/Senior Medical Director is responsible for the development and execution of clinical research and development programs for Agios including the leadership of the pivotal trials, NDA and/or filing activities. This role gives strategic medical and tactical input to the Business Development team. This position serves as a key liaison between company and clinical investigators and establishes credible relationships with opinion leaders, and regulatory officials. What you will do: Direct involvement in trial design of Phase I/II/III targeting rare or orphan diseases. Provide on-going support for open-label extension periods and life cycle management of a product. Directly supervise and monitor trial conduct as well as work closely with external medical monitor physicians to assure consistency of conduct across trials. Work closely with all functions of the organization and external partners to manage trial execution. Provide medical input to global regulatory plans and regulatory meetings in partnership with regulatory affairs. Provide medical input to global safety leads and at safety meetings in partnership with safety and medical safety and risk management teams. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program. Develop effective relationships with clinical research organizations to ensure successful medical oversight of outsourced studies. Provide clinical assessments during disease/target evaluation, prioritization and selection, identifying novel therapeutics opportunities as well as critical study design and execution challenges. Support qualifications of pharmacodynamic/disease markers of assessment of efficacy. Work closely with the project management representative(s) to track trial status. Work closely with study physicians, as well as other project team members/functional areas to ensure regulatory compliance. Author and review clinical study reports, manuscripts, regulatory documents and other written material related to clinical study. Be responsible for the scientific quality of all clinical work. Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws. What you bring: M.D. or equivalent degree Board Certification, Board Eligibility or specialist accreditation in internal medicine or pediatrics; specific experience with classical hematologic diseases is desirable. 3-10 years in industry (biotech/pharma) specifically within Clinical Development or closely related functions Clinical and managerial experience within pharmaceutical trial design and conduc