Global Clinical Development Lead, Toxicology

Roche Holding AG; Indianapolis (IN); On-site; USD 150,000 - 250,000; Full time

Benefits offered by this job

Discretionary annual bonus

Job summary

Roche Diagnostics Solutions (RDS) is seeking a Clinical Development Lead (Drug Testing) in Indianapolis to steer global clinical programs, translate insights into evidence, and drive regulatory strategy across markets. You will pair medical insight with data to support diagnostic innovation and patient access.

The role requires senior leadership, extensive regulatory and diagnostics experience, and the ability to collaborate across regions.

Qualifications

• Requires PhD/MD/DO/PharmD with 8+ years or Master’s with 12+ years experience.
• Experience with clinical toxicology, laboratory medicine, addiction medicine, clinical chemistry or related discipline preferred.
• Substantial FDA registration experience and multi-market regulatory submissions is highly desirable.

Responsibilities

• Lead Global Clinical Strategy for complex toxicology programs ensuring clinical utility and market differentiation.
• Interact with global regulatory bodies to accelerate product registrations and prepare regulatory responses.
• Pioneer integration of Real-World Evidence into clinical strategies and lifecycle decisions.
• Build and sustain relationships with international KOLs and academic partners to support portfolio leadership.
• Oversee global scientific communication and advocacy at major medical congresses and translate unmet clinical needs into development priorities.
• Drive innovation, IP strategies, and optimization of clinical processes across programs.
• Mentor and coach team members to develop skills and expertise.

Skills

Clinical development leadership

Regulatory knowledge

Diagnostics experience

Cross-functional collaboration

Strategic leadership

Travel readiness

Education

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

Master's degree

Job description

Roche Diagnostics Solutions (RDS) is seeking a Clinical Development Lead (Drug Testing) in Indianapolis to steer global clinical programs, translate insights into evidence, and drive regulatory strategy across markets. You will pair medical insight with data to support diagnostic innovation and patient access.

The role requires senior leadership, extensive regulatory and diagnostics experience, and the ability to collaborate across regions.