Gilead Sciences, Inc.
Director, Clinical Development (MD)
Gilead Sciences, Inc., Santa Monica, California, United States, 90403
* 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* Board certification/specialization in Hematology or Oncology* At least 2 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* May travel up to 30%Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. #J-18808-Ljbffr
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* May travel up to 30%Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. #J-18808-Ljbffr