Clinical Development Leader

Experience : 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. Experience with clinical toxicology, laboratory medicine, addiction medicine, clinical chemistry, or a related discipline is preferred.

Clinical Development expertise: Demonstrated experience of designing and leading large, complex clinical development programs across all stages of the product development and guiding cross-functional, matrixed teams. Experience translating clinical needs and product claims into executable clinical evidence strategies is strongly desired.

Regulatory Knowledge : 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. Experience developing evidence strategies capable of supporting registration across multiple major markets is highly desirable.

Diagnostics Experience : 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.

Inclusion & Collaboration : Ability to partner effectively across diverse regions, cultures, and time zones to foster an environment of belonging and collaboration.

Strategic Leadership : 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.

Travel : Willingness to travel up to 25% depending on project phases.

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.

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