The Position
At Roche, our Global Product Development Safety & Risk Management (PDS) department aims to enhance healthcare for patients by elucidating and communicating the safety profile of Roche medicines to optimise their benefit-risk profile.

The Opportunity
The Senior Group Director of Safety Development & Processes (SDP) provides strategic leadership, expertise and oversight for a global team in the design, development, implementation and coordination of activities relating to safety development, innovation, process design and continuous improvement, on behalf of PDS.

As a member of the PVSD Leadership Team, the Senior Group Director leads the global SDP function across 4 global product development sites (Basel in Switzerland, South San Francisco in the USA, Welwyn in the UK, and Mississauga in Canada). The role ensures that safety-critical processes are designed, developed, ‘owned’ and supported in line with business requirements and continuous improvement goals. They ensure that pilots, projects and major programs, intended to improve scientific safety approaches, are delivered or coordinated in line with agreed plans. They are also responsible for ensuring that PDS ‘ways of working’ adapt to changing customer requirements, and that the wider PDS community have access to expert advice in support of their efforts to deliver value to drug development and patient risk management.

The Senior Group Director is responsible for ensuring the SDP team fosters innovation, anticipates and acts on significant new developments or improvements required to PDS ways of working, and provides effective input to future enablement strategies in PDS.

The Senior Group Director leverages the strengths of a diverse global team and creates an inspiring environment where the SDP team members feel empowered to take ownership of deliverables, build knowledge and deploy resources effectively, always striving for continuous improvement and innovation. They are accountable for the implementation and functioning of defined global and/or functional process(es), including the links with associated systems/tools design/development, across the broad safety-related areas of the team's remit.

The SDP team's remit spans the following main areas:

• The design, development, maintenance, oversight, and continuous improvement of the Safety processes in compliance with GVP, GCP, and Medical Device domains.
• Sustaining the organisation’s ability to execute Safety processes through the provision of both technical and scientific expertise.
• The design, development, implementation, and coordination of both strategic and continuous improvement activities that advance PDS’s short and long-term objectives.
• Facilitation and coordination of safety innovation in cohesion with the needs of the Safety processes.
• Provision of niche scientific expertise that potentially benefits the needs of the portfolio.

Primary Responsibilities and Accountabilities:

• Leadership: Provides line-leadership for the global SDP sub-function; coaches members to maximise potential and well-being while sustaining a climate of purpose and urgency
• Strategic Direction: Responsible for defining and articulating vision and strategy for SDP, in alignment with the overarching PVSD, PDS and wider enterprise strategies
• Partnering closely with various functions in Pharma based on emerging business-critical need.
• Accountable for ensuring SDP can anticipate, develop, and support improved/consistent scientific ‘ways of working’, and/or design and implement effective Safety processes; ultimately to ensure that PDS delivers on its strategic aims, drives effective scientific decision-making and plays a leading role in sustaining overall Safety & PV system quality.
• May be personally responsible for assuming a formal role as PDS/PVSD representative on compliance governance bodies (e.g. GxP Council representation).
• Resource Management: Oversees recruitment, onboarding and effective deployment of SDP resources across multiple locations based on prioritised business need/value.
• Stakeholder & Strategy: Partners and maintains relationships with R&D wide key stakeholders; anticipates future opportunities via internal/external networks. Contributes to PVSD leadership in scenario planning, prioritisation, and budget management

Who you are

• You are a highly developed, senior leader with the proven ability to lead global line- or matrix- teams.
• You hold an advanced degree in a directly relevant discipline, or are a qualified health professional (MD, PharmD, etc), supported by at least 10+ years of experience in areas directly related to patient safety/pharmacovigilance (PV), typically gained via a senior role in the biopharmaceutical industry or a Regulatory Authority.
• You bring a post-graduate qualification in an area relevant to PV (e.g. PV Diploma or MSc) and/or business improvement or innovation (e.g. MBA; Lean Sigma certification) would be desirable.
• You have significant business experience in areas directly relevant to patient safety, pharmacovigilance, clinical development, medical devices, business performance management, strategic business analysis, process management and/or closely related disciplines, and essentially, you have a detailed understanding of how to ensure safety/PV related activities need to be established, sustained, improved or adopt innovation; to improve the company’s organisational capabilities across critical safety related disciplines that ultimately benefit patients.
• You can apply analytical thinking to the design, implementation, review and/or delivery of complex, cross-functional processes, measures, metrics, key performance indicators and/or management information system design.
• You utilise highly developed communication and influencing skills to build global collaborations and drive decisions

Location & Travel Requirements
This position must be based in either Basel, Switzerland or Welwyn Garden City in the United Kingdom. Although this can be a hybrid role, there is an expectation of ongoing and sustained site presence, in compliance with local company site requirements. International business travel may be required. Typically, this will be required around 15% of the time, depending upon the site location of the jobholder and/or the requirements of the role for ongoing leadership or business project-related activities.

Roche is an Equal Opportunity Employer.