Sr. Director, Therapeutic Area Head of GDD Risk Management

Sr. Medical Director, Head of Medical Risk Management

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs including in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia, and Phenylketonuria. **

The impact you will make:**

Agios Pharmaceuticals is searching for a dynamic Sr. Medical Director, Head of Medical Risk Management to join our Medical Safety and Risk Management 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 Head of Medical Risk Management will be responsible for overall safety and risk management strategy for all assigned drug candidates/products. **

What you will do:**

• Provides medical and drug safety expertise to oversee and lead decision making based on complex benefit/risk evaluation, clinical trial and post marketing data interpretation, risk assessment and risk management activities
• Manage a team of global safety leads
• Unite with Head of Global Safety Science in supporting and overseeing safety surveillance, signal detection and evaluation, according to SOPs and guidelines.
• Proactively assess and evaluate the clinical implications of safety data from all sources (including pre- clinical studies, clinical studies, literature, registries) in order to expertly understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing setting
• Ensure that important safety issues are brought up in a timely fashion with a deep comprehension of the potential issue.
• Unite with the Head of Safety Science in identifying topics for safety governance meetings, ensuring high quality presentations and discussions
• Represent Medical Safety at the Project Team(s) and Development Sub-teams as a core member
• Accountable for the safety components of clinical study reports, aggregate reports, regulatory responses and filing documents and other key clinical and regulatory documents
• Contribute to IND/CTAs, annual safety reports, project plans, project documents and presentations
• Strategically contribute to the development of key safety messages for internal communications and reviews all communication to the public from a safety point of view
• Contribute to scientific publications (abstracts, posters, papers) for scientific meetings and approves the submissions from a safety perspective
• Contribute to the writing of the RMP/REMS NDA documents and their maintenance, in uniting with the safety sciences function
• Bring safety expertise in interaction with Health Authorities, Data Safety Monitoring Boards and Investigators
• Provide reinforcement to medical review of individual case safety reports (ICSRs)
• Contribute to continuing improvement of Medical Safety processes and systems
• Report to the VP, Head, Medical Safety and Risk Management, and reinforce other activities as needed

What you bring:

• MD or DO degree with a minimum of 3 years of medical practice experience and a minimum of 5-10 years of industry experience in safety and medical risk management
• Previous experience in drug safety pre-approval (ranging from early to late-stage) and in the post-marketing setting
• Demonstrated knowledge of medical safety risk management and signal detection/evaluation
• Solid knowledge and comprehension of global pharmacovigilance regulatory requirements and general regulatory expectations
• Fluent in verbal and written English
• Strong written and verbal communication skills to a variety of levels and teams, internally and externally. Demonstrated persuasion, influencing and negotiation skills
• Ability to interact effectively and collaboratively in multifunctional teams

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description. **

What we will give you:**

• Deliberate Development. Your professional growth as 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, wellbeing 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.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.