Clinical Development Leader

Roche•Indianapolis, IN

2d•$138,700 - $257,500•Hybrid

About The Position

At Roche Diagnostics Solutions (RDS), our mission is to diagnose earlier, develop faster, and personalize treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally. We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster. Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life.

Requirements

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.
Substantial hands-on experience with US FDA registration—including FDA interactions, regulatory submissions and responses to agency questions—is strongly preferred.
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.

Nice To Haves

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.
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.

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.