Clinical Program Manager

Position Overview

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

People Leaders

People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

EXAMPLE RESPONSIBILITIES

• 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.
• Partners with cross-functional teams manage, adjust and revise project timelines and budgets as needed.
• 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.

Salary Range

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

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.

Equal Employment Opportunity

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.