Vice President Global Head of Early Development, Late Stage and Marketed Medicines Safety

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The Position

Purpose

They are also accountable for ensuring that early clinical development safety, late stage and marketed medicines safety, quality management and GCP compliance requirements are continually met; and that resources and information are shared effectively.

Fostering an environment where relevant safety experts build a shared awareness of molecule safety strategies and take an ‘entire lifecycle view’ with regard to the safety and risk management of each asset. They work closely with the Global Head, PCS to ensure that wider scientific/HCP resources are successfully recruited, trained, developed and flexibly deployed to support current and future Safety Program Leader requirements.

Ultimately their functions aim to generate safety knowledge that can be pivotal to portfolio-level decisions.

Highly effective line-leadership abilities are crucial for the role. The successful candidate must promote consistent high quality delivery and scientific impact; a growth mindset; and a culture of agility. They will inspire and guide both the line-leaders and safety experts within their function to continually develop their collective technical and leadership/influencing abilities; promote a culture of knowledge and resourcing sharing; foster cross-functional collaboration; continuous learning and delivery of best-in-class scientific safety research.

The post-holder will be expected to travel globally, typically >30% of time.

Primary Responsibilities and Accountabilities

• Models the Roche Values and Leadership Commitments.
• Sets senior leadership direction in terms of remit, emphasis, style, behaviours and culture for the global function.
• Drives and embeds the agreed organizational models, the necessary mindsets: promoting new ways of working and empowering line-leaders and employees.
• Leading self and others, often influencing without authority, to deliver outcomes.
• Brings critical, systematic thinking to shape current issues and opportunities into meaningful, deliverable actions.
• Anticipates potential issues, risks and opportunities, and takes action as needed.
• Willing to challenge embedded behaviours/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.
• Supports the PDS LT, other peers and direct reports so that they can take appropriate accountability for their practices and actions.

• Accountable for functional unit planning, prioritisation, goal & incentive setting.
• Accountable for ensuring the global function has appropriate mechanisms in place to ensure performance oversight of scientific-, quality- and compliance-related service/output delivery.
• Accountable for overseeing Line Leaders and Safety Program Leaders who are dedicated to the development, implementation and evolution of proactive safety and risk management strategies for each medical asset, in alignment with relevant Roche plans (e.g. target product profiles, etc.).
• Accountable for ensuring appropriate consistency of approach/performance, both within and across relevant disease areas: ensuring the safety profiles of molecules that are managed by the function are effectively and preemptively characterised; that safety characteristics are appropriately differentiated where relevant; and identified clinical risks have effective management strategies.
• Responsible for promoting a portfolio mindset throughout the function, to set the tone for collaboration, resource and knowledge sharing, both within PDS and more widely across Roche.

• Actively participates as a core member of the PDS LT, contributing as a member of this collective leadership team to shape and deliver upon shared organisational priorities, in addition to representing the perspective of the function itself.
• Building strong partnerships with other PDS functions, building and sustaining rapport and trust with the Head of PDS, peers and other stakeholders.
• Collaborating closely with internal Roche stakeholders to deliver on organisational strategies (e.g. Corporate strategies; PDS/Safety Strategy) and shared priorities.
• Responsible for representing the overall function at wider leadership/managerial fora; participating on relevant cross-functional programs, steering teams, and governance bodies where appropriate (e.g. NC-DSC, Expedited Safety Review Committee; PD Leader meetings, etc.); and promoting the function and its services as a whole to relevant customers and stakeholders.

• Accountable for ensuring direct reports are overseeing the development and implementation of proactive Safety and Risk Management strategies for their relevant disease area clusters. Ensuring these are aligned with wider DA/molecule level plans and strategies (e.g. DA strategy, TPPs, CDPs, etc.) and that they position PDS to deliver effective program- and study- level safety design and decision-making influence.
• Ensure appropriate emphasis of activities, in terms of the strategic safety focus provided across the portfolio: ensuring that effective safety strategies are implemented; the success of safety risk minimization/mitigation plans are monitored; safety related activities and outputs that are important for effective portfolio-wide decision-making are effectively delivered; and approaches that aim to ‘personalise safety’ are implemented.
• Accountable for ensuring that safety strategy development and implementation across the function adopts relevant strategic approaches/solutions (e.g. co-development and utilisation of novel approaches developed via the Safety Strategy program; continuous improvements to ways of working developed in collaboration with PVSD; adoption of new PHC-related innovations).

• Accountable for planning the capacity and prioritising the deployment of resources, to meet relevant portfolio demands, working jointly with PCS and the PDS BMO.
• Accountable, in partnership with the peer PDS functions and the PVSD Capability Development team, for co-developing and implementing effective learning and development approaches to equip current/future talent with the required blend of scientific, medical, leadership, influencing, communication and interpersonal skills that are/will be required to be fully effective.

• Leads a global function comprising experienced line leaders, scientists and health professionals. Sets the tone for the organisation in terms of the values and style of operating across the function.
• Creates, implements and drives the vision and organization of the function, its people, and its approach to delivering business processes and practices that add value to its various customers.
• Ensures a “high performance team culture”, where performance of employees is actively managed and supported (e.g. via coaching, training, development and performance management).
• Complies with all relevant employment laws, regulations and company HR policies and procedures, that are relevant to the locations where they operate.

• Preferred Qualifications: candidates would typically be medically qualified (MD; MB ChB; or equivalent) and would typically possess extensive experience in clinical pharmaceutical research and development and clinical safety.
• Candidates will typically possess more than 15 years of experience within a biopharmaceutical or clinical/medical research environment. They are likely to have considerable experience in safety-related aspects of clinical drug development (e.g. translational safety/medicine, and or the design and conduct of First in Human studies), or in clinical drug safety more generally.
• Candidates who have experience in performing senior line- or matrix- leadership roles in support of successful clinical development programs (e.g. in support of translation safety activities; in the design of pre-approval development programs; in supporting medical safety governance and/or scientific decision-making activities) are strongly preferred. Knowledge or experience of working within relevant Roche operating models would be advantageous.
• Demonstrable people leadership skills, typically with experience of delivering effective organisational line-leadership at senior levels, would be strongly preferred. An understanding of the key factors involved in supporting organisational talent and skills development (e.g. provision of effective learning, training and coaching approaches within large organisations) would be highly advantageous.
• Significant knowledge/experience of early clinical development, late stage, marketed medicines and the various safety-related scientific activities that are involved today, or could potentially become more prominent in this arena in future as the scientific research progresses, would be strongly preferred.
• Experience of leading teams to successfully design and conduct early clinical program safety activities in alignment with relevant GCP-safety, pharmacovigilance or quality management requirements, would also be highly advantageous.
• A proven ability to understand, manage and make key decisions with respect to significant clinical safety issues, often in situations of ambiguity, is essential. Ideally candidates will have experience in leading in safety management, benefit-risk, issue management and/or clinical risk management situations within a bio-pharmaceutical or healthcare organisation.
• Strong conceptual and strategic/systems thinking, combined with the ability to communicate and implement a strategy throughout an organization.
• Strong proven track record in leading and managing across cultures and geographies; with a demonstrable track record in leading and managing organisations through transformational change would be desirable.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization, including at the most senior levels, to create positive partnerships. Strong influencing, negotiation and conflict management skills. Ability to influence with and without authority.
• Where the jobholder is medically qualified, they may be required to perform specific duties that require specific medical qualifications / certifications (e.g. performing a formal medical approver/signatory role for medico-legal reasons; and/or chairing a medical safety governance body for operational reasons).

Who we are

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Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

Roche is an Equal Opportunity Employer.