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Clinical Development Lead – Oncology / Pathology

Roche
5+ years
preferred by company
Tucson, United States
1 May 14, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

Clinical Development Lead – Oncology / Pathology

Company: Roche
Location: Tucson
Department: Research & Development – Clinical Development / Oncology Diagnostics
Job ID: 202603-107748
Employment Type: Full-time
Work Mode: On-site


About Roche

Roche is a global healthcare leader focused on advancing diagnostics and therapeutics to improve patient outcomes through innovation, scientific excellence, and personalized healthcare solutions.


Position Overview

The Clinical Development Lead – Oncology / Pathology is a senior leadership role responsible for driving the clinical development strategy, study design, regulatory scientific leadership, and external partnerships for innovative diagnostic solutions in oncology and tissue-based pathology.

This position primarily focuses on:

  • Companion Diagnostics (CDx)
  • Personalized Healthcare (PHC)
  • In Vitro Diagnostics (IVD)
  • Oncology clinical development
  • Tissue-based pathology innovation

The role combines clinical science, regulatory leadership, medical affairs collaboration, product development strategy, and stakeholder management.


Key Responsibilities

1. Clinical Development Strategy

  • Define and implement clinical development strategies for oncology/pathology diagnostic products.
  • Support novel diagnostic solution development aligned with business objectives.
  • Contribute significantly to therapeutic area strategy and development roadmap.
  • Drive early pipeline innovation initiatives.

2. Clinical Study Design & Execution

  • Design scientifically robust clinical studies and development programs.
  • Lead study protocol development and execution planning.
  • Oversee study conduct, performance, and milestone delivery.
  • Review clinical study outcomes and interpret findings.
  • Generate clinical study reports supporting product development.

3. Regulatory & Submission Leadership

  • Lead scientific/medical contributions to regulatory submissions.
  • Prepare responses to health authority reviewer questions.
  • Support regulatory documentation for diagnostic product approvals.
  • Participate in interactions with regulatory agencies where required.

Relevant regulatory domains:

  • FDA
  • Global IVD regulatory frameworks
  • Companion diagnostic approvals

4. Cross-Functional Leadership

Collaborate with:

  • Clinical Operations
  • Regulatory Affairs
  • Biometrics / Biostatistics
  • Product Development
  • Quality Assurance
  • Business Strategy teams
  • Medical Affairs
  • Alliance partners

Responsibilities:

  • Ensure execution of aligned clinical strategies
  • Drive collaboration across multiple departments
  • Support business and operational excellence goals