As the Safety Strategy Leader (SSL) you are responsible for the safety profile and patient risk management strategy for their assigned product/molecule/program(s) (hereafter referred to as program(s)). 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) or Late-stage & Marketed Medicines Safety (LMMS). 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 Safety Science (PSS).
You play the leading role in shaping the strategic safety direction and planning safety strategy activities for their assigned program(s). This would include defining long-term safety-related objectives for their program(s), acting as the lead point of contact for safety for wider cross-functional leaders (LCL, ISL, GDL and equivalent roles); 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. You are accountable for ensuring that program-specific safety communications and patient risk management approaches are implemented and can be demonstrated to be effective in achieving their defined aims.
As SSL you are centrally involved in safety-related and benefit-risk decision-making activities for their program(s). You will effectively engage and influence multiple cross-functional partners (e.g. Triad or equivalent cross-functional development teams, Regulatory Leader, Medical Affairs & Affiliate-based SMEs, as appropriate) 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
Performing the SSL role require a blend of scientific safety expertise relevant to their assigned program(s), combined with relevant leadership, influencing and communication abilities: In order to ensure that the value of the scientific safety activities delivered in support of the program(s) has optimal impact throughout the life-cycle. You bring:
- Completed scientific or MD degree and 5 or more years of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
- Demonstrated team leadership in industry
- Strong orientation towards cross-functional teamwork
- Relevant levels and types of scientific/medical/PV expertise (e.g. required level of experience to lead from the scientific/strategic perspective, in the relevant phase of the product lifecycle, the disease area, and in terms of the nature of anticipated safety issues requiring management, etc).
- 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; and who can also guide the collaborative efforts of scientists/HCPs across PDS functions that need to play a part in progressing the safety strategy and delivering the various safety/PV requirements
- 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
- High degree of knowledge of PV tools and methods of managing risk and when/how to deploy; keen to apply new ways of working, tools/technologies relevant to safety science as they emerge thus championing new approaches and solutions as an early adopter
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