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Director Clinical Development EU

Director Clinical Development EU

Gilead SciencesUxbridge, England, United Kingdom
30+ days ago
Job type
  • Full-time
Job description

Join to apply for the Director Clinical Development EU role at Gilead Sciences .

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.

About Kite Pharma

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognise and kill tumours. Kite Europe is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs.

About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV / AIDS, liver diseases, haematology and oncology, inflammatory and respiratory diseases, and cardiovascular conditions. Following the 2017 acquisition of Kite Pharma by Gilead Sciences, Kite will be using the established Gilead infrastructure to bring its innovative oncology therapies to Europe.

Responsibilities

  • 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 preferably with board certification / specialization in Hematology or Oncology and experience managing oncology trials
  • 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%

    Equal Employment Opportunity (EEO)

    It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

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