Clinical Development Lead, Oncology/pathology

Roche UK

Tucson, Arizona, USA
Base: 120,500-223,700; bonus/equity: discretionary...
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Clinical study design and execution
Regulatory submissions and health authority interactions
Companion diagnostic/personalized healthcare solutions
** Roche UK is seeking a Clinical Development Lead in Oncology/Pathology to oversee clinical development activities for diagnostic solutions, particularly focusing on companion diagnostics and personalized healthcare. The ideal candidate should have a strong background in life sciences, extensive experience in clinical development, and familiarity with regulatory requirements. **

Job Summary

  • The Clinical Development Lead, Oncology/Pathology is responsible for planning and implementation of Clinical Development activities for novel medical value diagnostic solutions in the areas of oncology and tissue-based pathology.
  • Designs scientifically sound clinical studies and study programs in cross-functional teams and makes substantial contributions to the Clinical Development strategy for the relevant therapeutic/disease area(s).
  • Maintains clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation, and builds strong relationships with external thought leaders.

Matching Summary

Match Score: 75

** Roche UK is seeking a Clinical Development Lead in Oncology/Pathology to oversee clinical development activities for diagnostic solutions, particularly focusing on companion diagnostics and personalized healthcare. The ideal candidate should have a strong background in life sciences, extensive experience in clinical development, and familiarity with regulatory requirements. **

Salary

Base: 120,500-223,700; Bonus/Equity: Discretionary annual bonus; Benefits: Detailed at provided link

Skills & Requirements

Must-have

  • Clinical study design and execution
  • Regulatory submissions and health authority interactions
  • Companion diagnostic/Personalized Healthcare solutions
  • Oncology and tissue-based pathology expertise
  • Cross-functional team collaboration

Nice-to-have

  • Patient and customer-centricity
  • Innovation and intellectual property strategy
  • External development partnerships
  • Coaching and process optimization

Key Requirements

  • Medical degree or advanced degree (PhD, PharmD or equivalent)
  • 7+ years academic, diagnostics or pharma industry experience
  • Familiarity with global regulatory bodies (FDA, EMA, PMDA)
  • Knowledge of ICH-GCP, IVDD/IVDR, MDR, FDA, NMPA regulations
  • Ability to travel up to 10%

Work Rights

Not specified

Tailored Resume

Cover Letter