Associate Director, Global Safety Lead

The Impact You Will Make

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.

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
• Safeguards important safety issues in a timely manner; 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
• 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
• Conducts/supports routine and ad hoc signal detection and evaluations according to SOPs and guidelines
• Contributes to continuing improvement of MSRM processes and systems
• Supports product Therapeutic Area head in other activities as appropriate

What You Bring

• 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