Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
Job Description
Oversees global Benefit Risk (BR) activities across Cell Therapy. The successful candidate will serve on the Safety Leadership Team reporting to the Kite Head of Safety and Pharmacovigilance and will provide leadership, strategic guidance, and vision to the Kite Benefit Risk team. They represent Safety in oversight of global patient registries and post-marketing data across Cell Therapy. The Benefit Risk team’s contributions include: REMS, aRMMs, RMPs, non-interventional post-authorization studies, registries, liaisons with international partners.
Job responsibilities:
Liaises with the Head of Kite Safety to identify and pursue global and long-term goals for REMS, aRMMs, RMPs, non-interventional post-authorization studies, and registries and provides support for the strategic goals of the business.
Liaises with the Kite and Gilead functions outside of Kite Safety who are responsible for health-authority-required non-interventional studies and real-world data
Ensures that BR work is compliant with all current regulations pertaining to post-marketing and clinical trial product safety, as well as company policies.
Monitors industry best practices and regulatory guidance. Plans and oversees continuous process improvement and development related to global patient registries and post-marketing data activities.
Oversees root-cause analyses and identification of solutions with consideration of the impact on processes within and external to Kite Safety
Works with EU Qualified Person for Pharmacovigilance (QPPV), international regulatory and other stakeholders to craft and fulfil EMA postmarketing commitments. Works similarly within non-US non-EU geographies where Kite operates.
Ensures appropriate representation of the BR function for Pharmacovigilance audits and inspections
Develops global contacts across Kite and Gilead and externally to increase the visibility of BR
Contributes to budget planning and management for the global BR group
Knowledge and Skills:
Expert understanding of PV regulations and drug development
Excellent scientific/clinical and analytical knowledge base with ability to assess data and understand the safety/medical implications
In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies
Good knowledge of statistical methods used in PV
Excellent attention to detail and organizational skills.
Excellent verbal and written communication skills and strong interpersonal skills
Ability to make significant contributions to strategy planning within the Kite Safety department and oversee process improvement within Kite Safety
Ability to handle increasing and/or changing responsibilities such as team growth, integration efforts across other departments or organization
Ability to independently lead a diverse global team while mentoring and developing junior staff
Ability to build a network with external PV experts
Basic Qualifications:
Advanced scientific degree (i.e. MD, PharmD, PhD) or professional qualification in a life science field (e.g., nursing, or pharmacy) or a relevant scientific/technical discipline with 10+ years of demonstrated experience with the responsibilities, deliverables, and skills required for this level – OR –
MA/MS degree in life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline with14+ years of demonstrated experience with the responsibilities, deliverables, and skills required for this level -OR –
BA/BS degree in life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline with16+ years of demonstrated experience with the responsibilities, deliverables, and skills required for this level
Preferred Qualifications:
Colorado Job Applicants: The salary range for this position is:
$238,160.00 – $357,240.00
Kite considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
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:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 [email protected] for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ (http://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf) 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
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)
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.
Gilead 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 log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
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