Clinical Program Development Jobs in Lomita, CA (NOW HIRING)

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.

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.

POSITION OVERVIEW:

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 Operationsis responsible forthe 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 performedin accordance withapplicable SOPs, companypoliciesand regulatory guidelines to providetimelyand high-quality clinical data that supports global registration and commercialization of Gilead's products.

You will managea team of direct and potentially indirect reports.You will oversee andbe responsible forthe successful execution of studies and/or multiple studies within a program or multiple programs, includingfinancial responsibility.You willbe responsible forthe resource management of studies, including ongoing assessment of resource needs andoptimaldeployment of resources to support a fluid 'One Ops' workforce.You willparticipateand engage in Clinical Operations and/or cross-functional organizational change initiatives.You may act as the business process owner (BPO)and/or serve as asubject matter expertfor Clinical Operationsprocesses.You will encourage an innovative mindset by championingnew ideasand initiatives andincorporating best practices, externalbenchmarkingand standardization across Clinical Operations.

EXAMPLE RESPONSIBILITIES:

• Typically managesa team of direct reportsand may have indirect reports.Hires,developsandretainsdiverse top talent on the team. Sets clear goals for the team andindividualsdirect reports.Coaches'direct reports on their performance,developmentand career interests.

• May provide input into strategic and operational short- and long-range therapeutic area / functional area plans asappropriate, 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)andinfluences 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 metinalignmentwithproject 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.

• Resolvesissues as needed within national and international regulations and guidelines.

• Usesall available tools to track, oversee andcommunicate onprogram 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,implementationand training.

• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.

• Ensuresteam'sworkcomplies withestablished practices,policiesand processes,and anyregulatoryor other requirements.

Basic Qualifications:

Bachelor's Degree and Eight Years' Experience

OR

Masters' Degree and Six Years' Experience

OR

PhD / PharmD

Preferred Qualifications:

• Typicallyhasaminimum 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.

• Typicallyhassome 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, asevidencedby independence in designing,implementingandmanaging studyteam plans,deliverablesand resource management.

• Complete knowledge of full cycle study management, from start-up to close-out.

• Advanced knowledge of studymanagementbest practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.

• Thoroughknowledge ofFood & Drug Administration (FDA)andEuropean Medicines Agency (EMA), and other applicable nationalregulations,International Council forHarmonisationof Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelinesand Good Clinical Practice (GCP)governing the conduct of clinical studies.

• Proven ability toeffectivelyauthor clinical study and regulatory documentation.

• Ability to lead and influence programs,projectsand/or initiatives.

• Strong interpersonal skills and understanding of team dynamics.

• Proven ability to work successfully in a team-oriented,highly-matrixedenvironment.

• Demonstratedeffectivenesscoaching,guidingand directing the work of others, effectively managing performance of others, and developing team capabilities.

• Demonstrated effectivenessinproactively managing change.

• Strong communicationand organizational skills.

• When needed,abilityto 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:

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.

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 contactApplicantAccommodations@gilead.com for assistance.

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

Please apply via the Internal Career Opportunities portal in Workday.