Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
Who We Are
TheProduct Development Safety (PDS) organization delivers patient-centric scientific safety solutions that build trust and create value for society, leading to smarter safety design and decision-making activities throughout the drug lifecycle. PDS sustains Pharmacovigilance (PV) system compliance and quality, in order to foster trust and drive efficiency, while also innovating and improving the capabilities that address the evolving priorities of our enterprise and wider healthcare ecosystem.
We shape clinical safety, risk management approaches, and safety decisions across the entire asset lifecycle-from early development prior to pivotal stage development through to marketed molecules. In close collaboration with cross-functional stakeholders, we drive and implement scientific safety strategies to optimize patient risk management at every stage of molecule maturity.
The Opportunity
TheGlobal Head of Clinical Safety, Development and Marketed Medicinesprovides global strategic leadership across early development (pre-IND through early clinical phases) and late-stage/marketed assets (pivotal trials through post-loss-of-exclusivity).
As a core member of the PD Safety Leadership Team, this role shapes Roche’s end-to-end clinical safety and risk management strategies across all therapeutic areas and modalities (medicinal products, devices, ATMPs).
This role leads a team of 9 therapeutic area leaders and oversees an organization of approximately 60 physicians/scientists, who act as the strategic safety leads for all of Roche's development and on-market portfolio. Additionally, the job holder partners closely with the Global Head of Portfolio Clinical Safety, who oversees the safety scientists that support the strategic safety leads, ensuring that the scientific safety needs of all programs are appropriately met.
By taking an 'entire lifecycle view', this role ensures seamless knowledge transfer across phase transitions, drives cross-functional alignment with R partners (e.g., gRED, pRED, CICoR, PD), and acts as a key point of escalation for portfolio-level safety decisions and governance (e.g., Drug Safety Committee, Development Boards).
Primary Responsibilities and Accountabilities
Strategic Safety& Portfolio Delivery
- Direct the global strategy for proactive safety and risk management, aligning asset strategies with Target Product Profiles (TPPs) and Clinical Development Plans (CDPs).
- Oversee early-to-late phase safety transitions, optimizing risk minimization strategies, personalized safety approaches, and translational safety inputs.
- Ensure effective representation and input on key governance bodies (e.g., Drug Safety Committee, Translational Safety Committee, Development Boards) and lead safety due diligence for portfolio decisions.
Strategic Partnering& Escalation
- Collaborate closely with PDS peers (e.g., Portfolio Clinical Safety, PV& Scientific Development) and broader R groups to drive agile, scientific safety approaches.
- Empower functional experts to lead cross-functional safety initiatives with senior Roche stakeholders and Board chairs.
- Serve as the global point of escalation for critical, complex, or ambiguous portfolio-level safety issues.
Strategic Resourcing& Capability Building
- Partner with PDS leadership to strategically manage capacity, talent deployment, and resource allocation across EDS and LMMS, and Clinical Safety more broadly, based on portfolio priorities.
- Drive capability development initiatives to equip teams with cutting-edge expertise in safety science, pharmacovigilance, data-driven innovations, and strategic influencing.
People Leadership& Culture
- Role model Roche Values and Leadership Commitments, fostering a high-performance, agile, and inclusive global culture across line leaders, scientists, and HCPs.
- Drive transformational change, cross-functional collaboration, and continuous learning, inspiring teams to deliver best-in-class scientific safety research.
Who You Are
- MD (or equivalent) with relevant board certification/eligibility and significant clinical experience (e.g., residency, fellowship, or clinical practice in a recognized specialty/subspecialty) is required.
- Post-graduate qualifications or certifications (e.g., MSc, PhD, or Fellowship in Epidemiology, Pharmacovigilance, Public Health, Clinical Pharmacology, or Toxicology) and/or extensive experience in clinical pharmaceutical research are strongly desired.
- Extensive experience (typically 15+ years) in the biopharmaceutical industry or clinical/medical research environment, with deep domain expertise in development and post-marketing clinical safety.
- Proven track record of senior line and matrix leadership, with demonstrated success in managing high-performing, geographically and culturally diverse organizations through transformational change.
- Direct experience leading clinical safety strategy for complex development programs, supporting medical safety governance, and managing safety issues in ambiguity.
- Thorough understanding of early clinical development, GCP-safety regulations, risk-benefit evaluations, safety due diligence, and global pharmacovigilance standards.
- Outstanding conceptual and strategic thinking skills, with a proven ability to influence senior cross-functional executives with and without authority.
- Proficient in navigating complex, multi-stakeholder matrix environments, building strong collaborative partnerships across organizational boundaries.
- Willingness to travel internationally ( >30%) and work across cultures.
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
