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Senior Medical Director, Clinical Development

United States - California - Santa MonicaClinical Development & Clinical OperationsRegular

Job Description

The Senior Medical Director, Clinical Development 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

  • 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
  • Provide clinical expertise and input for regulatory filings (i.e. BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
  • 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 assigned

Basic Qualifications

MD Degree and 12 years of clinical or biotech/pharma industry experience

Preferred Qualifications

  • Board certification/specialization in Hematology or Oncology and experience managing oncology trials
  • 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%