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Gilead Sciences, Inc. Director, Clinical Research Oncology in Morris Plains, New Jersey

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Job Description

Gilead has declared Hematology-Oncology as one of the key therapeutic areas for future growth. Gilead is growing its pipeline in immune oncology through internal research, partnerships and acquisitions. This role provides an exciting opportunity to participate in the future growth of Gilead Oncology. This role will play a key role in development of pipeline programs and will support evaluation of internal and external opportunities for expanding the pipeline.

Specific Responsibilities:

This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for Oncology. This Director, Clinical Research position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical Oncology.

Essential Duties and Job Functions:

  • Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines.

  • Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.

  • Provides ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.

  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

  • Also manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, 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.

  • Leads two or more specific components of cross-functional strategic initiatives.

Knowledge, Experience and Skills:

  • Excellent scientific written and oral communication skills are required.

  • Must possess a proven ability to work highly effectively with multiple departments.

  • Must be capable of working with attention to detail in a time sensitive environment.

  • 8+ years of relevant experience in clinical research with a PhD or BS/MS degree with extensive industry experience.

  • Strong familiarity with good clinical practices.

Desired Skills:

  • Familiarity with clinical Oncology preferred

  • Clinical or translational research experience preferred

  • Pharmaceutical/Biotech industry experience in clinical development preferred but not required

  • Successful leadership and management experience

  • Excellent organizational and communication skills are essential

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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.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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