Innovative Evidence Regulatory Policy & Strategy Lead

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As the Innovative Evidence Regulatory Policy and Strategy Lead, you will be the primary architect of our strategy to modernize how In Vitro Diagnostics (IVDs) and Medical Devices (MDs) are evaluated and approved by health authorities around the world. You will work primarily in the regulatory science space, shaping policies that transitions the industry from traditional, prospective clinical study models toward high-fidelity, data-driven evidence for regulatory decision making. Your mission is to bridge the gap between "what is possible" in data science and "what is acceptable" to global health authorities. You will lead our advocacy for acceptance of real world data/evidence, in silico analysis, synthetic data, and digital twins, ensuring these innovations become standard pillars of regulatory submissions. The Opportunity Have an enterprise view to provide insights that help advance innovative evidence strategies across the entire Roche Dia portfolio. These strategies will significantly reduce time to market and reduce product development costs. Policy Advocacy & Shaping: Represent the company in trade associations (e.g., AdvaMed, MedTech Europe) and working groups to influence RWE guidelines and legislative frameworks. Innovative Evidence Strategy: Lead the exploration and internal validation of "next-gen" evidence types, including: In Silico Trials: Using computational modeling to predict diagnostic performance. Synthetic Data: Leveraging generative AI to create robust datasets where real-world samples are scarce. Digital Twins: Developing virtual representations of patient cohorts to simulate diagnostic outcomes. Regulatory Intelligence: Monitor and analyze emerging RWE/RWD regulations from the FDA, EU, NMPA, and other global bodies, translating their impact into actionable business strategies. Cross-Functional Leadership: Partner with Data Science, RA, R&D, and Clinical Development & Medical Affairs teams to integrate RWE into pre-market submissions and post-market surveillance (class III IVDs). White Papers & Publication: Draft position papers and scientific publications that establish the company as a thought leader in computational regulatory science. Work with coalitions and other initiatives (e.g., IDERHA) to help advance Roche’s positions on Innovative Evidence. Who You Are Experience: 7-10+ years of professional experience in Data Science, Biostatistics, Regulatory Affairs or Regulatory Policy, specifically focused on leveraging RWE for product approvals or clearances. Education: Advanced degree (PhD) in Data Science, Public Policy, Pharmacology or a related field. Domain Expertise: Deep understanding of the IVD landscape (e.g., 510(k), PMA, IVDR) and the specific nuances of diagnostic performance requirements (e.g., sensitivity, specificity, LoD). Dealing With Ambiguity: Proven ability to operate effectively, make decisions and maintain productivity when a situation is uncertain, information is incomplete, or the way forward is not clearly defined. Technical Literacy: Demonstrated expertise with the methodologies behind computational modeling, and RWD source curation (e.g., EMR, claims data, registry data). Strategic Communication: Ability to distill complex technical data into persuasive narratives for non-technical stakeholders and regulatory reviewers. Influence Without Authority: Proven ability to foster positive partnerships through effective influencing, negotiation, and conflict management skills to achieve alignment throughout the organization. Experience working with and presenting to global health authorities such as the US FDA, China NMPA, Japan MHLW, Health Canada, and Brazil ANVISA Locations This role is primarily onsite in Santa Clara. Relocation Benefits are not available for this opportunity. The expected salary range for this position based on the primary location of Santa Clara is $194,250 to $360,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Who we are A healthier future drives us to innovate. 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. Let’s build a healthier future, together. Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.