Clinical Development Lead, Oncology/Pathology
About The Position
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 at Roche Diagnostic Solutions (RDS), with a primary focus on Companion diagnostic/Personalized Healthcare solutions. This role involves designing scientifically sound clinical studies and study programs in cross-functional teams, making substantial contributions to the Clinical Development strategy, and leading clinical study design and execution. The lead will also work with various internal functions to ensure appropriate implementation of clinical development strategies and provide medical/scientific input for regulatory submissions. Additionally, the role involves building relationships with external thought leaders and cross-functional leaders, driving innovation, developing partnerships, conducting literature reviews, solving complex problems, and coaching colleagues. The position emphasizes patient and customer-centricity, collaboration across diverse regions, and adaptability in a fast-paced, matrixed environment, modeling Roche’s values of integrity, courage, and passion.
Requirements
- Medical degree or advanced degree (PhD, PharmD or equivalent) in Life Sciences, Oncology, Immunology, Molecular Biology and or Anatomic Pathology
- 7+ years academic, diagnostics or pharma industry experience
- Familiarity with global regulatory bodies (FDA, EMA, PMDA)
- Good knowledge in applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, FDA, NMPA regulations etc.) and understanding of the healthcare industry or equivalent academic experience
- In-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial, etc. and can proactively integrate multiple perspectives into the clinical development process and strategy for best end-results
- Ability to work with pharmaceutical partners to align the development of a diagnostic test with the development of a specific cancer drug
- Ability to travel required up to 10% (can vary per project phase and position)
- Ability to work independently
Responsibilities
- Designs scientifically sound clinical studies and study programs in cross-functional teams
- Makes substantial contributions to the Clinical Development strategy for the relevant therapeutic/disease area(s)
- Leads clinical study design and execution, including critical review of study results, protocol and report generation to support new product development
- Works with colleagues from Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, Business, and other functions to ensure appropriate implementation of clinical development strategies
- Leads medical/scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies
- May participate in external interactions with health authorities (HAs)
- Maintains clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation
- Builds and maintains close relationships with external thought leaders, supports preparation of advisory boards within the assigned indication area
- Builds and maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellence
- Drives competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy
- Develops and manages external development partnerships (industry and academia)
- Leads comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content (without guidance/direction)
- Solves or leads others to solve complex outcomes; uses sophisticated analytical thought to exercise judgment and identify innovative solutions
- Acts as a coach for colleagues with less experience and helps them develop skills/expertise
- Permanently optimizes processes to increase quality and efficiency standards
- Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first
- Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
- Working across Medical Affairs and Clinical Operations communities to identify mutual value and opportunities for collaboration
- Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial
- Model Roche’s values of integrity, courage, and passion (culture, mindset and behaviors)
Benefits
- Discretionary annual bonus may be available based on individual and company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
