Associate Director, Medical Review Lead, MSRMAt 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 seeking an Associate Director, Medical Review Lead to join the Medical Risk Management organization within Medical Safety & Risk Management (MSRM).This role provides oversight of medical review for Individual Case Safety Reports (ICSRs) across investigational and marketed products, ensuring medical accuracy, regulatory compliance, and high-quality safety data to support pharmacovigilance and risk management activities. Reporting to the Sr. Director, Head of Medical Risk Management, the Medical Review Lead serves as the primary point of contact for medical review and partners closely with Global Safety Leads, Pharmacovigilance Operations, and external vendors. This role bridges ICSR medical review and case processing with broader safety surveillance and risk management activities across the product lifecycle. The successful candidate will work cross-functionally and externally to ensure alignment with company policies, contractual obligations, and global regulatory requirements. This role requires strong medical and operational expertise in case processing and medical review, as well as the ability to effectively guide and oversee vendor performance in a dynamic and evolving environment.
What You Will Do:- Serve as the primary MSRM point of contact for ICSR medical review, partnering with Global Safety Leads, PV Operations, and vendors to ensure high-quality, compliant safety case assessment.
- Provide medical oversight of ICSR review for investigational and marketed products, ensuring accuracy, consistency, and scientific rigor of medical assessments.
- Review and approve key medical components of ICSRs, including narratives, coding, seriousness, expectedness, and company causality, based on source documentation.
- Perform and oversee quality control (QC) of medical review activities, providing feedback and driving vendor accountability to quality and performance standards.
- Ensure timely and compliant review of ICSR to ensure, including performing medical review activities directly when needed.
- Partner cross-functionally to support safety surveillance, risk management activities, and development of clinical and regulatory documents.
- Contribute to operational excellence through KPI/KQI monitoring, SOP development, training, and participation in system and process improvement.
- Support inspection readiness by identifying quality issues, contributing to CAPAs, and representing MSRM for medical review and case management activities.
- What You BringMD/DO with a minimum of 3 years of relevant drug safety/pharmacovigilance Medical Review experience.
- Minimum 1-2 years of vendor oversight in the biotechnology / pharmaceutical industry.
- Expertise with MedDRA and WhoDD dictionary coding.
- Expertise with software-based drug safety systems (ARGUS, ARISg, or equivalent)
- Solid understanding of expedited safety reporting.
- Solid knowledge of ICH and global regulations for clinical development and post-market activities pertaining to safety data collection, processing and reporting.
- Excellent communication and interpersonal skills including the ability to interact effectively and collaboratively in cross-functional teams.
- Excellent written and spoken English.
- Strong computer skills (MS Office).Ability to successfully prioritize and multi-task.
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!
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. 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.
