Clinical Program Manager

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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.

We believe every employee deserves a great leader. 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.

Job Description

As the Clinical Program Manager you will...

Specific 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.

• 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.

• Ensures successful planning and execution of global and regional Late Phase studies: Including post-marketing required safety/effectiveness studies.

• Partners with cross-functional teams to 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.

• Participates 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.

• Ensures teams work complies with established practices policies and processes and any regulatory or other requirements.
  

Basic Qualifications:

• 8 Years with BS/BA
  OR
• 6 Years with MS/MA or MBA
  

Preferred Qualifications:

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.

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.

Relevant clinical trial experience in the pharmaceutical industry.

Experience in oncology and/or ATIMP clinical trials preferred.

Experience in Phase IV clinical trials including post marketed required studies advantageous.

Solid line management experience including recruiting managing team members as well as mentoring and developing junior staff preferred.

Experience in clinical study management and project oversight is essential including timeline and budget management

Experience in developing RFPs selection and management of CROs/vendors.

Ability to write study protocols study reports sections for investigator brochures and regulatory documents with minimal supervision

Excellent interpersonal skills and demonstrated ability to lead is required

Strong communication influencing skills and ability to create a clear sense of direction is necessary

Fluency in English including both oral and written communications.

Must be able to resolve problems using national and international regulations guidelines and investigator interaction.

Extensive knowledge of ICH GCP and GVP FDA and EMEA regulations & guidelines.

Knowledge of drug development & commercialization processes.

Functional expertise to initiate author or contribute to SOP development implementation and training.

Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.

Must meet all requirements for the position and have demonstrated proficiency in all relevant areas.

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 the 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

For additional benefits information visit:

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.