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Medical Director, Clinical Development - Hematology/Oncology

United States – Remote, United States - California - Santa MonicaClinical Development & Clinical OperationsRegular

Descrizione del lavoro

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

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.

The Medical Director of Hematology/Oncology provides medical monitoring to multiple clinical trials. Additionally, the 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 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 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
  • 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
  • Provide clinical guidance 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)

Basic Qualifications

MD/DO degree and 4+ years of clinical or biotech/pharma industry experience


Preferred Qualifications

  • Board certification/specialization in Hematology or Oncology and experience managing oncology trials
  • Lymphoma/Myeloma experience
  • Randomized phase 2 or 3 study experience
  • Cell therapy experience
  • 3+ years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience
  • Demonstrated 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
  • 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 in a self-guided manner 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 dynamic small company environment with minimal direction and able to adjust workload based upon changing priorities
  • May travel up to 25%

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The salary range for this position is: $232,220.00 - $300,520.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.


For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.


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