Director, Global Safety Lead

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 disease – 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, Global Safety Lead 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 Global Safety Lead is an exciting opportunity within the Medical Safety and Risk Management (MSRM) function at Agios to drive and develop safety and risk management strategy in our rare genetic disease program. The Global Safety Lead will have an important role in implementing best-in-class safety and risk management processes and working with multiple functions across the company.

What you will do:

• Responsible for safety strategy for one or more clinical protocols and/or products
• Proactively assesses and evaluates the clinical implications of safety data from all sources in order to understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing settings as appropriate
• Ensures that important safety issues are addressed in a timely fashion; ensures a deep understanding of the potential issue and high-quality data presentations
• Represents medical safety at the Clinical Trial Working Group(s) for each assigned protocol
• Responsible for driving collaborative and timely safety discussions at Safety Management Team(s)
• Contributes to key clinical and regulatory documents including safety sections of protocols, investigator brochures and informed consent forms, and regulatory submissions including IND, NDA and PIP/PSP documents.
• Contributes to scientific publications (abstracts, posters, papers) for scientific meetings and approves the submissions from a safety perspective
• Strategically contributes to the development of key safety messages for internal communications and reviews all communication to the public from a safety point of view
• Contributes to safety documents including periodic safety reports (including DSURs, PADERs and PBRERs)
• Contributes to the writing and/or review of the RMP/REMS documents and their maintenance, in collaboration with the safety sciences function
• Prepares and participates in independent data monitoring committee (IDMC) meetings
• With support from safety scientists, conducts/supports routine and ad hoc signal detection and evaluations according to SOPs and guidelines
• Contributes to continuing improvement of MSRM processes and systems
• Provides support to ICSR medical review as needed
• Supports product Therapeutic Area head in other activities as appropriate
  
  

What you bring:

• MD/DO with a minimum of 6 years of industry experience in safety or clinical development and relevant clinical practice experience. Complete residency program in hematology is a plus.
• Previous experience in drug safety pre-approval (ranging from early to late-stage) and/or in the post-marketing setting.
• Demonstrated knowledge and tangible experience in pharmacovigilance and risk management.
• Solid knowledge and understanding of global pharmacovigilance regulatory requirements and general regulatory expectations
• Fluent in verbal and written English.
• Excellent written/verbal communication and interpersonal skills
• Demonstrated persuasion, influencing and negotiation skills to effectively drive discussions and decisions toward desired end-results.
• Ability to interact effectively and collaboratively in cross-functional 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 are all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you are at your best, we are 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 are continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We are 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.