Director, Medical Safety and Risk Management, Global Safety Sciences

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 rare 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 in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Director, Medical Safety and Risk Management to join our growing Global Safety Sciences 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 Director, Medical Safety and Risk Management will be responsible for the successful strategy, oversight, and execution of deliverables associated with aggregate reports and for independent work on other scientist tasks including but not limited to signal detection, process improvements, and risk reviews. This position ensures aggregate report outputs and report body development are done according to Agios’s global standard operating procedures (SOPs) and global regulations and guidelines.

This position will directly manage safety scientists in support of multiple programs.

What you will do:

• Organize, direct and manage technical and human resources to efficiently support the management of aggregate safety reports in accordance with global safety regulations in a scalable approach
• Develop, maintain (including regulatory intel), ensure training, and enforce written procedures related to aggregate reports for Agios products
• Liaise with safety systems for aggregate report and other GSSG required outputs
• Conduct signal detection and management activities
• Develop and maintain risk management plans
• Manage direct report performance against goals; supporting and consulting as necessary
• Provide vendor oversight as needed
• Serve as functional owner of SOPs and Work Instructions related to functional area
• Serve as a point of escalation for issue resolution
• Drive timely decisions and appropriately shift functional timelines, resources and priorities
• Collaborate with medical risk management function
  
  

What you bring:

• Bachelors Degree required
• Health care professional (e.g. RN, pharmacist, or other life sciences experience) with a minimum of 6 years of relevant drug safety/pharmacovigilance experience; training in pharmacology, epidemiology or regulatory science is a plus
• Knowledge of current industry standards and benchmarks
• Able to oversee and manage direct reports and vendors
• Extensive knowledge and experience with MedDRA and drug coding dictionaries, management and development of aggregate reports and signal detection, evaluation and management
• Advanced knowledge of US and EU pharmacovigilance regulations for development and marketed products
• Fluent in verbal and written English
• Strong planning, process mapping, and organization skills
• Consistently and effectively balance decisions with imperatives for ethics and efficacy
• Strong orientation to teamwork
• Strong negotiation skills to effectively drive discussions and decisions toward desired end-results
• Excellent written/verbal communication and interpersonal skills
  
  

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.