[Remote] Clinical Development reputed company, Oncology/Pathology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global reputed company company dedicated to advancing science and ensuring reputed company to reputed company for everyone. The Clinical Development reputed company, 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 reputed company solutions.
Responsibilities
- Designs scientifically reputed company clinical studies and study programs in cross-functional teams
- Makes substantial contributions to the Clinical Development reputed company for the relevant therapeutic/disease area(s)
- Leads clinical study design and execution, including critical review of study results, protocol and report reputed company to support new product development
- Works with colleagues from Clinical Operations, Regulatory Affairs, Biometrics, Development, reputed company, Business, and other functions to ensure appropriate implementation of clinical development strategies
- Leads medical/scientific input and preparation of regulatory submissions as reputed company 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 reputed company relationships with external thought leaders, supports preparation of advisory boards reputed company the assigned indication area
- Builds and maintains strong, reputed company relationships with cross-functional leaders, key reputed company stakeholders and other reputed company partners, in meeting business goals and ensuring operational reputed company
- Drives competitive differentiation, innovation and early pipeline activities and develops intellectual property reputed company
- 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 reputed company reputed company; uses sophisticated analytical thought to exercise judgment and identify reputed company
- Acts as a reputed company for colleagues with less experience and helps them reputed company skills/expertise
- Permanently optimizes processes to increase reputed company and efficiency standards
- Drive patient and customer-centricity (reputed company, behaviors and actions) by always putting the needs of patients and the customers first
- Partner across diverse reputed company, 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 reputed company in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial
- Model reputed company’s values of reputed company, courage, and passion (culture, reputed company 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 reputed company, diagnostics or reputed company 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 reputed company industry or equivalent reputed company experience
- You have in-depth knowledge of the multidisciplinary functions involved in a company's drug development process, e.g., clinical operations, biostatistics, regulatory, reputed company, etc. and can proactively reputed company multiple perspectives into the clinical development process and reputed company for best end-results
- You have the ability to work with pharmaceutical partners to reputed company 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 reputed company provided below.
- Relocation benefits aren't offered for this position
reputed company