Clinical Development Lead, Oncology/Pathology

Position Overview The Clinical Development Lead, Oncology/Pathology is responsible for planning and implementing clinical development activities for novel medical value diagnostic solutions in oncology and tissue‑based pathology, with a primary focus on companion diagnostic / personalized healthcare solutions at Roche Diagnostic Solutions (RDS). Key Responsibilities Design scientifically sound clinical studies and study programs in cross‑functional teams. Lead clinical study design and execution, including review of study results, protocol and report generation to support new product development. Collaborate with Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, Business, and other functions to ensure appropriate implementation of clinical development strategies. Lead medical/scientific input and preparation of regulatory submissions and responses to reviewers from regulatory agencies. Participate in external interactions with health authorities. Maintain clinical, regulatory, and scientific expertise related to IVD product development. Build and maintain relationships with external thought leaders, support advisory board preparation, and represent the indicated area. Identify and engage in external development partnerships (industry and academia). Conduct comprehensive literature reviews and create new scientific content. Coach and mentor less experienced colleagues. Continuously optimize processes to improve quality and efficiency. Drive patient‑ and customer‑centricity and model Roche’s values of integrity, courage, and passion. Qualifications Medical degree or advanced degree (PhD, PharmD, or equivalent) in Life Sciences, Oncology, Immunology, Molecular Biology, or Anatomic Pathology. 7+ years of academic, diagnostics, or pharma industry experience. Familiarity with global regulatory bodies (FDA, EMA, PMDA) and applicable standards (ICH‑GCP, IVDD/IVDR, MDR, FDA, NMPA, etc.). In‑depth knowledge of multidisciplinary functions involved in drug development (clinical operations, biostatistics, regulatory, commercial, etc.). Experience aligning the development of a diagnostic test with a specific cancer drug. Ability to travel up to 10% of the time. Ability to work independently in a fast‑paced, matrixed environment. Location & Compensation Primary location: Tucson, Arizona, USA (preferred). Remote US candidates may be considered. The position is not eligible for relocation benefits. Salary range: $120,500–$223,700, based on experience, qualifications, and location. A discretionary annual bonus may be available. Equal Opportunity Employment Roche is an equal‑opportunity employer. The company prohibits unlawful discrimination against protected classes and provides accommodations for applicants with disabilities. #J-18808-Ljbffr