Clinical Development Leader

Roche; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Roche Diagnostics Solutions (RDS) seeks an accomplished Clinical Development Lead to shape the future of toxicology and diagnostic innovation. You will bridge medical insights and evidence generation, guiding global clinical programs from concept to market adoption for advanced platforms like cobas i601.

Known for collaboration across partnerships, you will drive strategy, engage regulators, leverage RWE, and mentor teams to maintain Roche's scientific leadership in oncology and diagnostic

Qualifications

• Ph.D./M.D./D.O./Pharm.D. with 8+ years or a Master's with 12+ years of progressive experience in clinical development.
• Experience in clinical toxicology, laboratory medicine, addiction medicine, clinical chemistry or related disciplines.
• Proven leadership of large, cross-functional global development programs.

Responsibilities

• Lead Global Clinical Strategy for toxicology programs to ensure clinical utility and market differentiation.
• Strategize health authority interactions to accelerate product registrations and approvals.
• Pioneer Real-World Evidence integration to strengthen product claims.
• Build relationships with international KOLs and academic partners.
• Oversee global scientific communication at major medical congresses.
• Drive innovation, intellectual property strategies, and optimize clinical processes.
• Coach and mentor team members to develop expertise and confidence.

Skills

Clinical development leadership

Regulatory strategy

Real-World Evidence (RWE)

KOL engagement

Education

Ph.D./M.D./D.O./Pharm.D.

Master's with 12+ years of experience

Job description

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

At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise 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.

The Opportunity

Are you an accomplished clinical leader eager to shape the future of clinical toxicology and diagnostic innovation? As the Clinical Development Lead (Drug Testing), you will serve as the strategic clinical authority for Roche's toxicology and drug testing portfolio, including our advanced diagnostic platforms like the cobas i601. In this pivotal leadership role, you will bridge medical insights and evidence generation, defining and driving clinical programs that translate unmet patient needs into validated diagnostic solutions across global healthcare markets.

Key responsibilities include:

• 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.

Who you are

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 tr