Santa Monica, CA, 90407, USA
13 hours ago
Clinical Program Manager
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. **Job Description** 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. 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 team’s work complies with established practices, policies and processes, and any regulatory or other requirements. **Basic Qualifications:** + 8+ Years with BS/BAOR + 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 The salary range for this position is: $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 . **For 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 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 ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf) 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. **Change The World With Us** Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted. While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
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