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Director, Clinical Development (MD)-Oncology Early Development

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 24, 2023

Job Description:

Director, Clinical Development (MD)-Oncology Early DevelopmentUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scaleInclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Job DescriptionPOSITION OVERVIEW: You will typically lead multiple components of clinical trial programs in Oncology clinical development. You may also act as the Physician responsible on certain projects. For the assigned projects, you are accountable or various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.EXAMPLE RESPONSIBILITIES:

  • Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
  • Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
  • Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
  • Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
  • Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
  • Coordinates the collection and assimilation of ongoing data for internal analysis and review.
  • Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
  • Presents scientific information at scientific conferences as well as clinical study investigator meetings.
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Minimum Education & Experience
    • MD or equivalent with 4+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
    • Board certification in Oncology is preferred, including familiarity with clinical solid tumor and/or hematologic medicine.
    • Experience in the biopharma industry is preferred.
    • Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
    • Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
    • Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.Knowledge & Other Requirements
      • Proven analytical abilities as demonstrated through past experience and/or academic research.
      • Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
      • Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
      • Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
      • When needed, ability to travel.For jobs in the United States:As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.

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Keywords: Gilead Sciences, Inc., San Mateo , Director, Clinical Development (MD)-Oncology Early Development, Executive , San Mateo, California

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