Your browser cookies must be enabled in order to apply for this job. Please contact support@jobscore.com if you need further instruction on how to do that.

Senior Medical Director, Clinical Development

Clinical Development | Santa Monica, CA | Full Time

Job Description

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. For more information on Kite, please visit www.kitepharma.com.

 

The Senior Medical Director, Clinical Developments provides clinical leadership and input to the Vice President, Clinical Development on clinical studies, program strategies and life cycle management. He/she provides Clinical study and launch support and works closely with cross-functional groups that include Research, Translational Sciences, Clinical Operations, Regulatory, Patient Safety, Medical Affairs, and Commercial to ensure that Clinical Development scientific and medical strategies are aligned with broader corporate and patient needs. He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.

 

Responsibilities include, but are not limited to:

  • Lead project teams to strategically 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

  • 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

  • Provide clinical leadership 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)

  • Provide strategic support and work closely with Medical Science Liaisons (MSLs), participation and insight in MSL activities, such as KOL interactions

  • Provide medical support as needed on company and non-company sponsored studies, non-interventional studies and investigator sponsored studies

  • Perform other duties as required

 

Requirements:

  • M.D. degree is an absolute requirement with board certification/specialization in Hematology or Oncology and experience managing oncology trials

  • At least 5 years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience

  • 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, and demonstrated ability to positively represent the goals of Kite

  • 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 company environment with minimal direction and able to adjust workload based upon changing priorities

  • Excellent written and oral communication skills, including presentation skills

  • Possess an understanding of applicable US and EU drug development regulations and GCP regulations

  • May travel up to 20%

 

Kite Pharma is an equal opportunity employer based in beautiful Santa Monica, CA.  Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment. 

To learn more about us, please visit our website at www.kitepharma.com

No phone calls please and no agencies or recruiters.