<< ZURÜCK
BEWERBEN
von: F. Hoffmann-La Roche Ltd
At Roche you can show up as yourself, embraced for the unique qualities you bring. The Global Head of Early Development, Late Stage and Marketed Medicines Safety sets the strategic direction and provides global organizational leadership for their function. They empower line-leaders and experts within their teams to deliver safety leadership at the disease area and molecule/program levels. Their function takes the lead in shaping the clinical safety and risk management approach for all early development assets, from the pre-IND stage to the Late Stage & Marketed Medicines Safety (LMMS) function when pivotal stage planning builds-up. The Global Head is a member of the PDS leadership team and works in close collaboration with functions across PDS to deliver on the Safety Strategy & Value Propositions (e.g. 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; 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.
The postholder empowers relevant experts within their function to build relationships with senior Roche stakeholders and to take the lead on safety-related matters (e.g. with DRC chairs; cross-functional REDs leaders). They ensure relevant leaders are progressing fully aligned safety approaches in situations where parallel early development and late stage programs share common targets or mechanisms of action. The Global Head is responsible for acting as a point of escalation for portfolio-level safety issues when required, and they also collaborate with senior stakeholders (e.g. Early Clinical Development Heads) with regard to the general strategy and performance of the function as a whole. The Global Head may also perform a role on relevant governance bodies. The Global Head ensures their function is well positioned to support translational safety; the design of safety-related content of target products profiles, early clinical development plans and studies; and ensuring effective clinical risk management for subjects participating in early and late stage studies. The successful candidate must promote consistent high quality delivery and scientific impact; 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; 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.
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.
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; and identified clinical risks have effective management strategies.
Stakeholder Management and Relationship Building
Building strong partnerships with other PDS functions, building and sustaining rapport and trust with the Head of PDS, peers and other stakeholders.
Responsible for representing the overall function at wider leadership/managerial fora; PD Leader meetings, etc.); Accountable for ensuring direct reports are overseeing the development and implementation of proactive Safety and Risk Management strategies for their relevant disease area clusters. People Leadership & Line Management
Leads a global function comprising experienced line leaders, scientists and health professionals. Ensures a “high performance team culture”, where performance of employees is actively managed and supported (e.g. via coaching, training, development and performance management).
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; 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 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. 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; Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
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. 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.
<< ZURÜCK
BEWERBEN