Clinical Program Manager

Kite Pharma; Santa Monica (CA); On-site; USD 165,000 - 214,000; Full time

Job summary

Kite Pharma, based in Santa Monica, CA, seeks an experienced leader to drive Clinical Operations across Phase I–IV trials. You will manage a team, oversee study execution within budgets and timelines, and collaborate with cross-functional partners to optimize resource use in a fast-paced environment.

Role requires strong leadership, regulatory knowledge (FDA/EMA/ICH), and proven ability to drive complex studies from start-up to close-out. Some travel may be required.

Qualifications

• Typically at least 4 years’ cross-functional study management or related leadership in life sciences.
• Experience developing RFPs and managing CROs or vendors.
• Some experience managing direct reports.
• Proven ability to start-up, manage and close-out clinical studies and author study/regulatory documents.
• Advanced knowledge of FDA/EMA/ICH and GCP guidelines.

Responsibilities

• Leads cross-functional Study Management Teams (SMTs) and influences stakeholders.
• Oversees study budgets, timelines and resource deployment across programs.
• Partners with cross-functional teams to manage and adjust project plans.
• Escalates issues and communicates status to all stakeholders.
• Authors or contributes to study protocols and regulatory documents.
• Manages CRO/vendors and vendor selection processes.

Skills

Study management

Leadership

RFP development

CRO/vendor management

Team coaching

Regulatory knowledge

Education

Bachelor's degree

Master's degree

PhD / PharmD

Job description

Job Description

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. 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 be responsible for the 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 and engage in Clinical Operations and/or cross-functional organizational change initiatives. You may act as the business process owner (BPO) and/or serve as a subject matter expert for Clinical Operations processes. You will encourage an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking and standardization across Clinical Operations.

EXAMPLE RESPONSIBILITIES

• Typically manages a team of direct reports and may have indirect reports. Hires, develops and retains diverse top talent on the team. Sets clear goals for the team and individuals direct reports. Coaches’ direct reports on their performance, development and career interests.
• May provide input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation.
• Acts 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.
• Leads cross-functional Study Management Teams (SMTs) and influences all relevant stakeholders.
• Partners with cross-functional teams manage, adjust and revise project timelines and budgets as needed.
• Communicates project status and issues and ensures project team goals are met in alignment with project decisions. Escalates issues as needed.
• Participate in the development of all study-related documentation, including study protocols.
• Participates in the selection and management 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.
• As assigned, 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.

Basic Qualifications

Bachelor's Degree and Eight Years' Experience

OR

Masters' Degree and Six Years' Experience

OR

PhD / PharmD

Preferred Qualifications

• Typically has a 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.
• Typically has some 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 and has shown ability to apply these to improve study efficiencies and effectiveness.
• Thorough knowledge of Food & Drug Administration (FDA) and 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 coaching, guiding and directing the work of others, effectively managing performance of others, and developing team capabilities.
• Demonstrated effectiveness in proactively managing change.
• Strong communication and organizational skills.
• When needed, ability to travel.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem

The salary range for this position is

Bay Area: $182,070.00 - $235,620.00.

Other US Locations: $165,495.00 - $214,170.00.

Kite considers a variety of 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [e-mail] for assistance.

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

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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our 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.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.