Note: The job is a remote job and is open to candidates in USA. Roche is a global healthcare company focused on diagnostics and improving patient outcomes through innovation. The Clinical Development Leader will serve as the strategic clinical authority for Roche’s toxicology and drug testing portfolio, leading global clinical strategies, evidence generation, regulatory interactions, stakeholder partnerships, scientific communications, and team development.
Responsibilities
- Lead Global Clinical Strategy: Architect and execute high-impact clinical development strategies for complex toxicology programs to ensure clear clinical utility and market differentiation. Your leadership will bridge the gap from early concept to successful global adoption, directly impacting patient access to critical diagnostic insights
- Strategize and Mastermind Health Authority Interactions: Act as the primary scientific authority in high-stakes interactions with global regulatory bodies to accelerate product registrations. By crafting compelling clinical narratives and leading scientific responses, you will navigate the pathway to regulatory clearance and patient impact
- Revolutionize Evidence Generation: Pioneer the integration of Real-World Evidence (RWE) into clinical strategies to strengthen product claims and clinical adoption. By leveraging diverse data sources, you will enhance the robustness of our evidence packages and support lifecycle management decisions
- Cultivate Strategic Stakeholder Partnerships: Build and sustain influential relationships with international Key Opinion Leaders (KOLs) and academic partners to ensure our portfolio remains at the forefront of clinical practice. These collaborations will provide the scientific foundation for our next generation of toxicology innovations
- Elevate Scientific Communication and Advocacy: Command the implementation of global communication strategies to reinforce Roche’s scientific leadership at major medical congresses. Your advocacy will ensure that evolving unmet clinical needs in toxicology and addiction medicine are translated into actionable development priorities
- Champion Innovation & Excellence: Act as a key driver for competitive differentiation, innovation, and early pipeline activities while developing intellectual property strategies and optimizing clinical processes
- Coach and Mentor: Act as a dedicated coach for team members, nurturing confidence and helping colleagues develop their skills and expertise
Skills
- Proven leader directing complex clinical development programs across diagnostics, pharmaceuticals, medical devices, academia, or clinical practice, requiring a Ph.D./M.D./D.O/Pharm.D. with 8+ years or a Master's with 12+ years of progressive, relevant experience
- Demonstrated experience of designing and leading large, complex clinical development programs across all stages of the product development and guiding cross-functional, matrixed teams
- Demonstrated experience developing clinical evidence to support regulatory registration of IVDs, medical devices or closely related diagnostic products
- Experience with clinical toxicology, laboratory medicine, addiction medicine, clinical chemistry, or a related discipline is preferred
- Experience translating clinical needs and product claims into executable clinical evidence strategies is strongly desired
- Experience developing evidence strategies capable of supporting registration across multiple major markets is highly desirable
- Ability to partner effectively across diverse regions, cultures, and time zones to foster an environment of belonging and collaboration
- Ability to operate with a high degree of independence and accountability, navigate ambiguity, solve complex clinical-development challenges, and influence senior cross-functional stakeholders without direct authority
- Willingness to travel up to 25% depending on project phases
- For US based candidates this position is tied to the Indianapolis work location but has flexibility to work fully remote
- We are able to consider candidates based in Spain, UK or Austria. These locations will be on site
- No relocation benefits are available for this posting
- Substantial hands-on experience with US FDA registration—including FDA interactions, regulatory submissions and responses to agency questions—is strongly preferred
- Experience with IVD or diagnostic product development is strongly preferred, including familiarity with the scientific, clinical and regulatory considerations associated with diagnostic performance studies
- Experience designing, evaluating or leveraging real-world data for product development, regulatory strategy, clinical claims or post-market evidence generation is highly desirable
Benefits
- For US based candidates this position is tied to the Indianapolis work location but has flexibility to work fully remote.
- A discretionary annual bonus may be available based on individual and Company performance.
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