Note: The job is a remote job and is open to candidates in USA. Roche is a global healthcare company dedicated to advancing science and ensuring access to healthcare for everyone. The Clinical Development Lead, Oncology/Pathology will be responsible for planning and implementing clinical development activities for diagnostic solutions in oncology and pathology, focusing on Companion diagnostics and Personalized Healthcare solutions.
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)
Skills
- You have a medical degree or advanced degree (PhD, PharmD or equivalent) in Life Sciences, Oncology, Immunology, Molecular Biology and or Anatomic Pathology
- You have 7+ years academic, diagnostics or pharma industry experience
- You have familiarity with global regulatory bodies (FDA, EMA, PMDA)
- You have 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
- You have 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
- You have the ability to work with pharmaceutical partners to align the development of a diagnostic test with the development of a specific cancer drug
- You have the ability to travel required up to 10% (can vary per project phase and position)
- You have the ability to work independently
Benefits
- A discretionary annual bonus may be available based on individual and company performance.
- This position also qualifies for the benefits detailed at the link provided below.
- Relocation benefits aren't offered for this position
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