Medical Director, Clinical Development – Hematology/Oncology

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

The Medical Director of Hematology/Oncology provides medical monitoring to multiple clinical trials. Additionally, the Medical Director guides the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines.

Responsibilities

• Provide medical monitoring to multiple hematology/oncology clinical trials
• Lead project/study teams to 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
• Implement 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 ensure compliance with external guidelines
• Collaborate with internal pre-clinical scientists, translational scientists, and business and commercial organizations
• Work in a cross-functional team environment, including clinical operations, biomarker specialists, CROs, and regulatory affairs
• Provide clinical expertise and input for regulatory filings and respond to questions from regulatory authorities
• Provide clinical guidance and work with external stakeholders and internal teams

Requirements

• MD/DO degree and clinical development experience in the pharmaceutical industry
• Board certification/specialization in Hematology or Oncology and experience managing oncology trials
• CAR-T therapeutic area experience
• Multiple myeloma disease area expertise
• Phase 2 or 3 study experience in multiple myeloma CAR-T trials
• Relevant drug development experience, either within industry or academia
• Experience designing, implementing, and conducting clinical trials
• Knowledge of hematology/oncology clinical trials and treatment options
• Strategic leadership and tactical skills, initiative, and judgment
• Ability to develop and maintain excellent relationships with internal and external contacts
• Ability to work well in teams across functions
• Effective communication skills and ability to work independently
• Critical thinking and problem-solving skills
• Self-motivated and adaptable to changing priorities
• Willingness to travel up to 25%

Applicants outside of Stockley Park may be considered if all requirements are met.