Description:
Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.
The Medical Director of Hematology/Oncology provides medical monitoring to multiple clinical trials. Additionally, the Director guides the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines. This position reports to the Executive Medical Director of Clinical Development.
Responsibilities
- Provide medical monitoring to multiple hematology/oncology clinical trials
- Lead project teams to design and implement hematology/oncology clinical studies
- Write protocols, investigator brochures, clinical study reports and review clinical trial documents
- Conduct investigator meetings and lead site initiation visits with clinical trial investigators
- Implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate findings from research and nonclinical studies into clinical development opportunities
- Interact with clinical investigators and thought leaders
- Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
- Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
- Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
- Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
Basic Qualifications
MD/DO degree and 8+ years of clinical or biotech/pharma industry experience