Medical Director, Clinical Development

Job 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 leads 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 Vice President of Clinical Development.

Responsibilities

• Provide medical monitoring to multiple oncology clinical trials
• Lead project teams to design and implement 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
• Execute 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

Basic Qualifications

MD/DO degree and 8+ years of clinical or biotech/pharma industry experience

Preferred Qualifications

• Board certification/specialization in Hematology or Oncology and experience managing oncology trials
• Drug development experience, either within industry or as a clinical investigator/physician scientist in academia
• Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies
• Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options
• Strategic leadership and tactical skills, excellent initiative and judgment
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
• Demonstrated ability to work well in teams in a cross functional manner
• Ability to communicate and work independently with scientific/technical personnel
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• May travel up to 25%