Clinical Program Manager

About the role

At Gilead, our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention, as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical 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 manage a team of direct and potentially indirect reports, overseeing and being responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility. You will handle resource management of studies, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid ‘One Ops’ workforce. You will participate in Clinical Operations and/or cross-functional organizational change initiatives, potentially acting as the business process owner (BPO) and/or serving as a subject matter expert for Clinical Operations processes. You will encourage an innovative mindset by championing new ideas and initiatives, incorporating best practices, external benchmarking, and standardization across Clinical Operations.

Responsibilities

• Manage a team of direct reports and may have indirect reports; hire, develop, and retain diverse top talent.
• Set clear goals for the team and individual direct reports; coach direct reports on performance, development, and career interests.
• Provide input into strategic and operational short- and long-range therapeutic area/functional area plans as appropriate.
• Act as team leader and builder, providing guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.
• Lead cross-functional Study Management Teams (SMTs) and influence all relevant stakeholders.
• Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed.
• Communicate project status and issues, ensuring project team goals are met in alignment with project decisions; escalate issues as needed.
• Participate in the development of all study-related documentation, including study protocols.
• Participate in the selection and management of contract research organizations (CROs) / vendors, including development of requests for proposals (RFPs).
• Anticipate obstacles and difficulties and implement solutions to achieve project goals, including risk assessment and mitigation strategies.
• Resolve issues as needed within national and international regulations and guidelines.
• Use available tools to track, oversee, and communicate program status to all key stakeholders.
• Participate in and/or lead departmental or interdepartmental strategic initiatives.
• Initiate, author, or contribute to standard operating procedure (SOP) development, implementation, and training.
• Ensure team’s work complies with established practices, policies, and processes, and any regulatory or other requirements.

Requirements

• Bachelor’s Degree and eight years’ experience OR Master’s Degree and six years’ experience OR PhD/PharmD.

Qualifications

• Minimum of 4 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study management or project teams.
• Experience developing RFPs and selection and management of CROs or other vendors.
• Experience managing direct reports.
• Proven ability to successfully start-up, manage, and close-out clinical studies, including authoring clinical study and regulatory documentation and SOPs.
• 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, 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 when needed.

People Leader Accountabilities

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

Pay

The salary range for this position is:

• Other US Locations: $165,495.00 - $214,170.00
• Bay Area: $182,070.00 - $235,620.00

Kite 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.
• Additional benefits information available at Gilead Careers.

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