Global Clinical Development Lead, Toxicology & Diagnostics

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

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.