Clinical Program Manager, Early Phase Virology

About the role

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 ensure access to these therapies across the globe. Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas, ensuring trials are performed in accordance with applicable 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 and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility. You will manage resource needs and optimal deployment of resources to support a fluid ‘One Ops’ workforce. You may act as the business process owner (BPO) and/or serve as a subject matter expert for Clinical Operations processes. In this role, you will either act as an individual contributor or will be assigned people leader responsibilities, according to skill set and business need.

Responsibilities

• Provides ongoing financial oversight of clinical trials/programs assigned.
• May provide input into strategic and operational short- and long-range therapeutic area/functional area plans, including supporting alignment and communications to other team members upon implementation.
• Provides guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.
• Leads cross-functional Study Management Teams (SMTs) and influences all relevant stakeholders.
• Partners with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed.
• Communicates project status and issues, ensuring project team goals are met in alignment with project decisions. Escalates issues as needed.
• Participates in the development of all study-related documentation, including study protocols.
• Participates in the selection, management, and oversight of contract research organizations (CROs)/vendors, including development of requests for proposals (RFPs).
• Anticipates obstacles and difficulties and implements solutions to achieve project goals, including risk assessment and mitigation strategies.
• Resolves issues as needed within national and international regulations and guidelines.
• Uses all available tools to track, oversee, and communicate on program status to all key stakeholders.
• Participates in and/or leads departmental or interdepartmental strategic initiatives.
• Initiates, authors, or otherwise contributes to standard operating procedure (SOP) development, implementation, and training.
• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
• Ensures team’s work complies with established practices, policies, and processes, and any regulatory or other requirements.
• People Leader Path: Hires, develops, and retains diverse top talent on the team. Sets clear expectations for direct reports and coaches them on performance, development, and career interests.

Requirements

• BA/BS/RN with 8 or more years’ relevant clinical or related experience in life sciences, or MA/MS/PharmD/PhD with 6 or more years’ relevant clinical or related experience in life sciences.
• Minimum of 4 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study or project teams.
• Experience developing RFPs and selection and oversight/management of CROs or other vendors.
• Proven ability to successfully start-up, manage, and close-out clinical studies, including authoring clinical study and regulatory documentation and SOPs.
• Meets all requirements for Senior Clinical Trial Manager (Senior CTM) grade 28 position with demonstrable proficiency.

Qualifications

• Advanced knowledge of one or more disease or therapeutic areas, as evidenced by independence in designing, implementing, and managing study team plans, deliverables, and resource management.
• Complete knowledge of full-cycle study management, from start-up to close-out.
• Advanced knowledge of study management best practices and tools, with the ability to apply these to improve study efficiencies and effectiveness.
• Thorough 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.
• Proven ability to effectively author clinical study and regulatory documentation.
• Ability to lead and influence programs, projects, and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly-matrixed environment.
• Demonstrated effectiveness in coaching, guiding, and directing the work of others, managing performance, and developing team capabilities.
• Demonstrated effectiveness in proactively managing change.
• Strong communication and organizational skills.
• Ability to travel as required.

People Leader Accountabilities

• Create Inclusion: Model inclusion and embed the value of diversity in team management.
• Develop Talent: Understand skills, experience, aspirations, and potential of employees, and coach them on performance and future growth.
• Empower Teams: Align team goals with organizational objectives, hold teams accountable, and remove barriers to success.

Pay

The salary range for this position is $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Eligible employees may participate in additional benefit plans, subject to the terms and conditions of the applicable plans.