As the Safety Strategy Leader (SSL) you are responsible for the safety profile and patient risk management strategy for their assigned translational products with some emphasis on ophthalmology. Whilst deployed to perform the role, you are empowered to work independently under the oversight of a relevant Group Leader in Early Development Safety (EDS). You also provide program-specific scientific direction and guidance regarding the implementation of the safety profile for a matrix team/network of safety scientists and HCPs who are typically assigned to support their program from Portfolio Clinical Science (PCS).
You play the leading role in shaping the strategic safety direction and planning safety strategy activities for their assigned projects. This would include acting as the lead point of contact for safety for wider cross-functional leaders; collaborating with the cross-functional team on the translations safety aspects, being responsible for the high-level safety program design/plan; guiding the scientific approach to the acquisition, monitoring, analysis/evaluation and communication/reporting of program-specific safety information.
You will articulate the overall design and the requirements of their defined safety strategy, in the context of the wider development program (e.g. the TPP, CDP) and/or the medical value narrative.
As SSL you are centrally involved in safety-related and benefit-risk decision-making activities for your assigned projects from pre entry into man to phase 2. You will effectively engage and influence multiple cross-functional partners in order to act as the key safety point of contact.
Your role is therefore considered to be pivotal to the overall success of the program(s) you are assigned to.
Who you are
Completed scientific degree (MD preferred) and 8 or more years of drug safety, discovery, clinical development or medical affairs experience in the pharmaceutical or related industry, ideally with some ophthalmology experience.
Demonstrated team leadership in industry
Strong orientation towards cross-functional teamwork
Translational scientific/medical/drug safety expertise
Demonstrated the potential to deliver this type of role in line with the leadership, influencing and communication abilities that are essential to effectively engage wider stakeholders;
Strategic thinking & strong analytical ability - able to apply critical and holistic thinking in terms of safety for ‘overall value add’ to deliver effective impact for cross-functional teams