R&D Director Oncology
Join a Top 5 Global Pharmaceutical Company
Lead Clinical Development Programs for Japan for across Oncology TA
- Industry leading global pharmaceutical company
Responsible for effective medical and scientific oversight of studies (in partnership with Clinical Scientists and Clinical Operations team members) and supports appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defence activities).
Leads Japan Clinical Development strategy for Oncology and supports the organisation of expert panels and advisory board meetings to provide input into clinical plans, study design and data analysis.
Act as the primary contact with external investigators and the internal study team for questions relating to clinical/medical aspects of the protocol.
Provide product/program specific medical input for target product profile(s), due diligence activities on potential in-licensing opportunities and regulatory documents as appropriate (e. g. product labels, core data sheets, Investigator's Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
Provides medical input to develop study outline and/or key protocol elements and proactively ensures efficient protocols that minimise the likelihood of amendments in a Therapeutic Area.
Serves as the primary contact with external investigators and internal study team for questions relating to clinical / medical aspects of protocol.
- Clinical Development and Operations at governance meetings (including co-development studies).
- Medical Doctor with previous experience with clinical research in oncology, including in academia, as an investigator, at a pharmaceutical company or CRO
Demonstrated knowledge of designing and delivering clinical program(s), to produce both timely and good quality data, including knowledge (and appropriate use) of innovative clinical trial principles and methodologies
- Regulatory awareness proven track record of proactive management of regulatory issues related to protocols and programs, including experience of interactions with regulatory authorities
- Opportunity to lead clinical development activities in Japan
- Contribute your medical expertise to oncology development programs in Japan
- Work / life balance