Director, Clinical Research (MD)
Gilead
IT
9 gg fa

Job Description

Responsibilities include, but are not limited to :

  • 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
  • Perform other duties as required
  • Support, provide input into regulatory filing documents, conduct regulatory filings
  • 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 small company environment with minimal direction and able to adjust workload based upon changing priorities
  • LI-KL1

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