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Medical Director, Clinical Development

United States - California - Santa MonicaClinical Development & Clinical OperationsRegular

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%