Medical Director/Senior Medical Director, Clinical Development

Agios Pharmaceuticals Inc • Cambridge, MA

50d • $221,600 - $461,900 • Remote

About The Position

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.

Requirements

• 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 conduct (POC through Phase 3 experience) within the pharmaceutical industry CRO or Academia is required. Experience with trials though NDA preferred, but not required
• Excellent interpersonal and public speaking skills are required for this high visibility position.

Responsibilities

• 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.

Benefits

• Deliberate Development. Your professional growth is one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, well-being, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree