Director - Safety Surveillance

About the Department                                                                                                                                               

Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.

 

The Position

This leadership role leads the safety surveillance sub-function within the U.S. East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety Scientists and Safety Scientists.

 

Contributes and provides oversight in the development of safety strategy and safety deliverables for assigned programs within the U.S. East Coast Development Hub portfolio in close collaboration with key stakeholders from Global Safety Surveillance and other cross functional teams.

 

Oversees daily operations of the function by directing staff and adhering to company-wide policies, procedures and programs. Manages organizational design, structure, development, training and planning issues within sub-function. Solid NN value chain understanding and execution. Proven track record of creating business results with impact on VP/CVP level.

 

Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and communicate safety information to internal and external stakeholders.

 

Relationships

This position will report to Senior Director Safety Surveillance, U.S. East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, and other affiliates.

 

External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/Associate within Safety Surveillance.

 

Essential Functions

• Innovation and change
  • Identifies needs and opportunities for overall strategic changes in the culture and organization or in the way by which the business is positioned
  • Identifies problems and significantly changes or improves existing methods and techniques drawing from personal experiences and feedback
  • Decisions are guided by strategic and tactical priorities and require complex analysis of situations and data
  • Establishes new or improved methods within field of expertise across EVP area
• Geographic responsibility
  • Ensures global scalability of solutions and understands the importance of involving various global stakeholders
  • Considers the impact of decisions and initiatives on other areas of the organization
  • Strong international visibility and independent interaction with the business globally

• Establishment of the product safety profile
  • Develop and update the minimum mandatory safety text (MMST) for use in the Informed Consent
  • Own the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products
  • Maintain the labelling for marketed produc