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Sr Director Clinical Development (MD) Pediatrics

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Oct 1, 2022

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Job Details

Sr Director Clinical Development (MD) Pediatrics
United States - California - Foster City

Gilead 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 scale
Inclusion 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 #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description


Job Description - Senior Director, Clinical Development (MD)

FUNCTION: Clinical Development
POSITION OVERVIEW:
You may act as a Clinical Development Lead and Physician responsible on clinical trial programs in Pediatric Oncology clinical development for the assigned molecules / products. As Clinical
Development Lead, you will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials for the assigned molecules /products. You may take the
lead on the development, implementation and execution of the clinical development strategy for the assigned molecules / products, which will include leading development of
the Target Product Profile and Clinical Development Plan. Additional responsibilities may include, but are not limited to, 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:
  • Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products.
  • Routinely represents the assigned molecules / products in cross-functional steering and /or governance committees.
  • May lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
  • May lead the Global Development Team for assigned molecules; providing scientific and clinical guidance to cross-functional teams and colleagues to meet clinical
    development project deliverables and timelines.
  • May act as a core team member on the Program Strategy Team, which is responsible for the full lifecycle management of the assigned products.
  • Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products.
  • In general, serves as the lead for communications, both written and oral, with health authorities.
  • Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety
    surveillance.
  • Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and
    development plans.
  • May directly manage or delegate and oversee the collection and assimilation of ongoing data for internal analysis and review and 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. Where applicable, takes a lead on authoring scientific
    publications.
  • May assist in the clinical evaluation of business development opportunities.
  • Develops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for assigned molecules
    /products.
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
  • May also manage one or more direct reports.

    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 careers@gilead.com 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 'EEO is the Law' 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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  • Company

    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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
     

    Find Us
    Website
    Location
    333 Lakeside Drive
    Foster City
    California
    94404
    United States
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