Group Director, Late Stage - Tuusula

Job summary

We advance science so that we all have more time with the people we love. Roche/Genentech's Product Development organization is organized by therapeutic area and plays a critical role in shaping and executing clinical strategies that bring medically differentiated therapies to patients. Our Global Product Safety team is a dedicated partner to ensure that every Roche product is both effective and safe.

Responsibilities

• You will be accountable for overseeing and guiding the performance of assigned SSLs, to ensure they consistently deliver in line with relevant business strategies, required behaviors, quality requirements, defined processes, and to agreed customer requirements.
• You will be responsible for supporting and shaping safety-related activities and stakeholder interactions that are routinely required at the disease area or franchise levels (i.e. activities that span across multiple molecules/programs, and may involve routinely collaborating with the Clinical Therapeutic Area Head for CVRM, relevant cross-functional leaders within the CVRM Therapeutic Area, CVRM Development Boards and Business Boards and the relevant teams/bodies that operate and make decisions at that level).
• You will collaborate with colleagues/cross functional leaders, to ensure delivery performance oversight and quality of outputs; seeking to address any issues holistically so that their shared customers receive a seamless service.
• You will ensure the leadership team remains informed of their team's delivery priorities, performance and they share information on relevant safety topics/issues, as appropriate.
• You will coordinate the transition of knowledge for those molecule assets that are transitioning through the various phases of development: Ensuring a robust and independent safety position is established/maintained/shared for the assets supported across their respective teams.
• You will support the assigned team to build relationships and grow their influence with relevant stakeholders to ensure scientific delivery impact, and the delivery of all required safety outputs is achieved in line with the organizational priorities/plans and to agreed customer requirements.
• You will act as an expert reviewer for relevant safety-related documents that have been prepared by the relevant SSLs and supporting teams (e.g. safety strategies and plans; safety content of protocols; DSRs; clinical study reports; Investigator's Brochure (IB); ; relevant safety communications; and safety-related scientific publications), as appropriate; You will collaborate and partner with PCS GD's and TL's to ensure co-development, implementation and monitoring of the effectiveness of risk assessment or risk mitigation approaches (e.g. guided safety questionnaires) and the overall execution of molecule/product-related safety support.
• You may be required to represent your team or functional perspective at relevant governance or decision bodies (e.g. GVP Council, DSC, Development Board, TA Advisory Meetings) and/or participate on relevant cross-functional programs (e.g. Safety Strategy teams; PD Leader meetings & TA initiatives that could impact the portfolio/safety function); You may be required to represent Roche Product Safety at external meetings with regulatory authorities and third parties such as potential licensing or co-development partners, etc. 
• You will be leading a global team of scientists and healthcare professionals performing SSL roles; You may be required to coach and support members of your teams when they are assigned to perform these types of activities.
• You will be responsible for building strong partnerships across the Product Development Organization; Collaborating with internal Roche stakeholders to ensure that they, and their assigned team, are delivering upon relevant molecule, disease and portfolio level strategies and shared priorities across the wider Roche organization; you will seek feedback from across the respective customer groups (e.g. Clinical Development, Medical Affairs, Affiliates, EU QPPV, etc) to ensure that the influence and impact of their teams and their scientific deliverables are continually adding value and are supporting the delivery of the Roche Product Safety strategy and value propositions.
   

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