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Manager of Clinical Trials in Virology Operations

2 months ago

San Mateo, California, United States Gilead Sciences Full time

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead, we are dedicated to fostering a healthier world for everyone.

For over 35 years, we have confronted diseases such as HIV, viral hepatitis, COVID-19, and cancer, tirelessly working to develop therapies that enhance lives and ensure global access to these treatments.

We persist in our battle against the most significant health challenges worldwide, and our mission necessitates collaboration, determination, and an unwavering commitment to making a difference.

Every member of Gilead's team is essential in the discovery and development of transformative scientific innovations.

Our workforce is our most valuable asset as we strive to achieve our ambitious goals, and we are seeking the next generation of passionate and driven individuals ready to make a tangible impact.

We believe that every employee deserves an exceptional leader. People Leaders are fundamental to the employee experience at Gilead and Kite.

As a people leader now or in the future, you will be a pivotal force in evolving our culture and fostering an environment where every employee feels included, developed, and empowered to realize their aspirations.

Join Gilead and help create possibilities, together.

POSITION OVERVIEW:


Clinical Operations is tasked with the global execution of all Phase I - IV clinical trials across all therapeutic areas at Gilead.

Clinical Operations plays a crucial role in ensuring that all Gilead clinical trials are conducted in accordance with relevant SOPs, company policies, and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead's products.

You will oversee a geographical region(s) of assigned clinical studies or multiple components of larger studies. Typically, you will manage Phase I studies or other smaller studies. You will define and integrate study logistics and plans to achieve clinical study objectives. You may also engage in strategic initiatives.

EXAMPLE RESPONSIBILITIES:

  • Oversees all aspects of small clinical studies, including Phase I studies.
  • Actively manages clinical study budgets and exercises proactive financial oversight.
  • Collaborates with other departments to effectively achieve study goals and objectives, ensuring cross-functional communication to meet project team targets.
  • With guidance, may lead the selection of contract research organizations (CROs) and vendors, overseeing and managing interactions and deliverables from relevant CROs, subcontractors, and vendors.
  • Serves as the primary operational contact for Gilead studies, providing oversight for site evaluation, initiation, and close-out visits, in addition to conducting oversight monitoring visits.
  • Defines study logistics and develops clinical study plans for assigned studies.
  • Manages study timelines, including documentation and communications.
  • Participates in and facilitates project meetings and conference calls with CROs, other vendors, and cross-functional teams as appropriate.
  • Contributes to the development of SOPs and participates in special projects. Develops tools and processes that enhance project efficiencies and effectiveness.
  • Provides input into study protocols, case report forms, and informed consents, overseeing and authoring study plans and presentations.
  • Monitors study sites/region and reviews routine regulatory documents to ensure compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
  • Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
  • May be required to present at internal or external meetings (i.e., investigator meetings).
  • Leads or assists in the preparation of safety, interim, and final study reports, including resolving any data discrepancies.
  • Proactively identifies potential operational challenges and collaborates with Clinical Operations colleagues to provide solutions to ensure study execution remains aligned with defined protocols, budgets, and timelines.
  • Assists in training new or less experienced colleagues.
  • Ensures compliance with established practices, policies, processes, and any regulatory or other requirements.

REQUIREMENTS:
We recognize that everyone is unique, and we value the distinct contributions each individual brings to serve patients. Below are the qualifications and skills we seek for this role.
Minimum Education & Experience

  • MA / MS / PharmD / PhD with 3+ years of relevant clinical or related experience in life sciences.
  • BA / BS / RN with 5+ years of relevant clinical or related experience in life sciences.
  • Several years of clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
  • Experience managing the work of external vendors.
Knowledge & Other Requirements

  • Demonstrated ability to learn quickly.
  • Proven flexibility and adaptability to change, with the ability to transition between projects and provide support/expertise as needed.
  • Ability to manage any component of full cycle study management, from start-up to close-out.
  • Advanced knowledge of study management best practices and tools, with a demonstrated ability to apply these to enhance study efficiencies and effectiveness.
  • Comprehensive understanding of protocol requirements and the ability to articulate and interpret these effectively.
  • Knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and Good Clinical Practice (GCP) governing the conduct of clinical studies.
  • Familiarity with standard medical/scientific terminology.
  • Ability to communicate clearly and concisely.
  • Ability to support a team-oriented, highly-matrixed environment.
  • Ability to execute multiple tasks as assigned.
  • Willingness to travel when necessary.

The salary range for this position is:
$143,000 - $185,000. Gilead considers various 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:

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

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.

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 assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE:

EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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

SummaryLocation:
United States - California - Foster CityType: Full time