Associate Director, Global Safety Lead

Agios Pharmaceuticals Inc • Cambridge, MA

5d • Hybrid

About The Position

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.

Requirements

• MD/DO with a minimum of 3 years of industry experience in safety or clinical development and relevant clinical practice experience.
• 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

Nice To Haves

• Complete residency program in hematology is a plus.

Responsibilities

• 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

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director