We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform. We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities. We continue to foster a productive research engine that yields new insights and potential therapeutic approaches. We’re a company that cares about our work, each other, and the people who are counting on us the most. We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results. We’re driven to be our best selves, together, so we can reach for the Other Side of Possible.
Agios Pharmaceuticals is searching for a dynamic Associate Medical Director to join our growing Clinical Development team. The Associate Medical Director will be responsible for the development and execution of clinical research and development programs for Agios Pharmaceuticals including the leadership of clinical trials. This role will give strategic medical and tactical input to the Genetically Defined Diseases (GDD) discovery teams from early discovery to development candidates to IND submission. This position will serve as a key liaison between company and clinical investigators and establish credible relationships with opinion leaders, and regulatory officials.
- Direct involvement in trial design of Phase I/II/III research trials targeting rare or orphan diseases.
- 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 logistics.
- Provide medical input to global regulatory plans and regulatory meetings in partnership with regulatory affairs.
- Follow important developments and relevant trends in the 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 external providers 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.
- Develop evidence for functional relevance of targets in human disease.
- 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.
- Review written materials and provide editorial comments for clinical study reports and manuscripts.
- 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.
- M.D. or equivalent degree
- Clinical research experience within trial design and conduct (POC, Phase I/Phase II and/or III) is required. Experience with trials through NDA strongly preferred.
- Excellent interpersonal and public speaking skills are required for this high visibility position.
- Demonstrated ability to work in a matrix environment with cross-functional teams.
- Demonstrated leadership experience.
- Approximately 10% annual travel (domestic and international) may be required for this position.
- Board Certification, Board Eligibility or specialist accreditation in internal medicine or pediatrics is preferred but not required; Specific experience with genetic metabolic disorders or hematology desirable.
- Translational research expertise and experience in rare/Orphan disease development desirable.