Vice President, Clinical Development

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 11, 2019
Ref
R0008504
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
The VP, Clinical Development is responsible for creating overall program strategy inclusive of early development/first-in-human through life cycle management and developing and overseeing the execution of the clinical study portfolio designed to meet these strategies. He/she works closely with cross-functional leadership that includes Research, Translational Sciences, Clinical Operations, Regulatory, Biostatistics, Patient Safety, Medical Affairs, and Commercial to ensure that Clinical Development scientific and medical strategies are aligned with broader corporate and patient needs. Cross-functional team leadership and line management of one or more direct reports are key components of the role. He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards. This role will report to the SVP, Development.

Responsibilities may include, but are not limited to:
  • Serve as a key leader of the R&D organization and provide clinical development advice and counsel to Kite governing and oversight bodies as needed
  • Create and champion near- and long-term strategic vision for one or more clinical assets in development
  • Lead program teams to design and implement hematology/oncology clinical studies to deliver on the strategic vision
  • Provide line management oversight and/or career mentorship to one or more direct reports (Senior/Executive Director level and below) as needed
  • Oversee development of protocols, investigator brochures, clinical study reports and review clinical trial documents
  • Maintain and develop new relationships with key opinion leaders and clinical 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
  • 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 medical support as needed on company and non-company sponsored studies, non-interventional studies and investigator sponsored studies
  • Perform other duties as required


Requirements:
  • MD degree or foreign equivalent is an absolute requirement with board certification/specialization in Hematology and/or Oncology and experience managing oncology trials
  • At least 8 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
  • 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%


#LI-JK2

Kite is a biopharmaceutical company 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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