Job Description

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.

Job Description

Position Overview

Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialization of Gilead’s products.

You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase I studies or other smaller studies.

You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives

Clinical Trials Manager, Clinical Operations

Specific Responsibilities and Skills for Position:

·       Manages all components of small clinical studies, including Phase I studies.

·       With guidance, may lead contract research organization (CRO) and vendor selection and, where applicable, manages all interactions and deliverables from relevant CROs and vendors.

·       Typically serves as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs.

·       Defines and develops the study logistics and clinical study plan for assigned clinical studies.

·       Manages study timelines, including documentation and communications.

·       Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.

·       Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.

·       Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.

·       Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs follow protocols, regulatory requirements, SOPs, and monitoring plans.

·       May be required to present at internal or external meetings (i.e., investigator meetings).

·       Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.

·       Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets, and timelines.

·       Assists in training new or less experienced colleagues.

·       Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

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

·       MA / MS / PharmD / PhD with 3+ years’ relevant clinical or related experience in life sciences.

·       BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences.

·       Multiple years’ 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.

·       Meets all requirements for Senior Clinical Trial Management Associate (Senior CTMA) grade 26 position with demonstrable proficiency.

Knowledge & Other Requirements

·       Demonstrated ability to be a fast learner.

·       Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where 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 and has shown ability to apply these to improve study efficiencies and effectiveness.

·       Fully understands protocol requirements and effectively articulates and interprets these.

·       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.

·       Familiar with standard medical / scientific terminology.

·       Ability to communicate in a clear and concise manner.

·       Ability to support a team-oriented, highly matrixed environment.

·       Ability to execute multiple tasks as assigned.

·       When needed, ability to travel.