Senior Medical Director, Clinical Development

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 02, 2020
Ref
R0014675
Required Education
Doctorate/PHD/MD
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

The Senior Medical Director, Clinical Development provides clinical leadership to cellular immunotherapy clinical study teams developing transformative therapies for life-threatening hematologic malignancies or solid tumors, leading to regulatory submissions and approvals. The successful candidate will have demonstrated expertise in clinical research of malignant disorders in a biotech/pharma setting and will have provided input to product teams on clinical studies, program strategies, and life cycle management. He/she will be the clinical leader on study teams and will work closely with cross-functional groups that include Pre-Clinical Research, Translational Sciences, Clinical Operations, Clinical Science, Regulatory Affairs, Biometrics, Patient Safety, Medical Affairs, and Commercial groups to ensure that Clinical Development 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. This position will report to the Vice President of Clinical Development.

This position is based in Santa Monica, CA (strongly preferred), but alternate locations can be considered.

Key Responsibilities:
  • Lead study teams to strategically design and implement hematology/oncology clinical studies
  • Write or review protocols, investigator brochures, clinical study reports, IND and NDA documents
  • Conduct investigator meetings, advisory board meetings, and site initiation visits
  • 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 Science, Biometrics, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
  • Provide strategic support and work closely with Medical Affairs, including the Medical Science Liaison (MSL) field force


Key Requirements:
  • MD degree or equivalent is required, with preference for board certification/specialization in Hematology or Oncology and patient-care experience
  • At least three years of relevant drug development experience, preferably within industry or equivalent experience
  • Proven clinical development strategist with experience designing, implementing, and conducting clinical trials, with emphasis on first-in-human studies or global registration studies
  • Knowledge of hematology/oncology disease management and 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 drug development regulations and GCP
  • May travel up to 20%


#IND123

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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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.