Clinical Development Leader

F. Hoffmann-La Roche AG; Indianapolis (IN); Hybrid; USD 139,000 - 258,000; Full time

Job summary

Roche Diagnostics Solutions in Indianapolis is seeking a Clinical Development Lead (Drug Testing) to shape the future of toxicology and diagnostic innovation. You will bridge medical insights and evidence generation to define clinical programs translating patient needs into validated diagnostics across markets.

The role requires senior leadership, regulatory experience with FDA interactions, and the ability to lead cross-functional teams across regions.

Qualifications

• PhD/MD/DO/PharmD with 8+ years in clinical development.
• Experience in clinical toxicology or diagnostic medicine preferred.
• Regulatory submissions and FDA interactions experience.
• Proven cross-functional leadership across global programs.
• Willing to travel up to 25%.

Responsibilities

• Lead global clinical strategy for complex toxicology programs.
• Interact with global health authorities to accelerate registrations.
• Integrate real-world evidence into clinical strategies.
• Build relationships with international KOLs and academic partners.
• Communicate Roche's scientific leadership at major congresses.
• Drive innovation, IP strategy and efficient clinical processes.
• Coach and mentor team members.

Skills

Clinical leadership

Regulatory interactions

Evidence generation

Stakeholder management

Strategic thinking

Education

PhD/MD/DO/PharmD with 8+ years

Master's with 12+ years

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

• 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

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.

Location: 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.

The expected salary range for this position based on the primary location of Indianapolis is $138,700 - $257,500 USD Annual. 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

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Indianapolis. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

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. Lets 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.