Associate Director, Global Safety Lead

Associate Director, Global Safety Lead

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific it's deeply personal, grounded in the meaningful connections we have built.

Agios Pharmaceuticals is searching for a dynamic AD, Global Safety Lead to join our growing 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.

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

MD/DO with a minimum of 3 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

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

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.

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. 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. The current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.

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.