Job Description We're here for one reason and one reason only
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 The Senior Director Patient Safety (MD) will serve as the safety strategy leader involved in safety related and benefit-risk decision making activities for assigned product(s) at Kite Pharma. The successful candidate will have demonstrated prior career success as a product safety physician and managing the medical safety strategy for products in development and post-marketing, as well as effectively engaged and influenced multiple cross functional teams including but not limited to Clinical Development, Regulatory, Biometrics, Medical Affairs, PV/Business partners, and Affiliates as appropriate. The Senior Director Patient Safety (MD) plays a lead role in owning, shaping and planning the safety strategy and activities for their assigned product(s). This would include acting as the lead point of contact for safety with cross functional leaders, defining safety related objectives, ability to articulate the overall design and the requirement of their defined safety strategy in the context of the overall clinical development program and or post-marketing requirements. This role is accountable for the safety profile, product specific patient risk management strategies and activities and ensure safety communications approaches are implemented and can be demonstrated to be effective. The Senior Director Patient Safety (MD) role is pivotal to the overall success of the product(s) they are assigned to. They are empowered to work independently under the oversight of VP, Head of Global Safety. Job responsibilities The Senior Medical Director is accountable for establishing and maintaining the company position on the safety profile and to shape the risk management strategy and proactive patient risk communication for their assigned product(s). They develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as relevant strategic context (e.g., safety profile of existing standard of care, treatment landscape) They are responsible for recommending appropriate safety monitoring measures for safety issues. They are accountable for signal detection and evaluation, aggregate safety reviews, and preparation of periodic aggregate safety report and the medical review oversight of SUSARs Lead safety signal surveillance, and aggregate data analysis for assigned product(s) on an ongoing basis in collaboration with the PV Scientist and/or Clinical Physician/Scientist. Will develop the strategy and implementation of safety and benefit-risk management for assigned products. Accountable for content in the aggregate reports (such as
DSUR, PADER, PBRER
) and Risk Management documents (RMPs) for assigned products. They contribute and provide expert content reviews for safety aspects of their product(s) for protocols, IBs, ICFs safety label updates, Safety management plan(s), Risk Management plan across the life cycle of the product(s) as well as long term follow up studies. Lead cross-functional product safety committee (PSC) meetings and collaborate with team members to ensure patient safety for assigned products. Support and collaborate with cross-functional teams on safety related activities, preparing and presenting safety data at meetings, providing responses to Health Authority requests, or business development queries. Support and contribute to the development of Pharmacovigilance Agreements as needed. Provide strategy and input into development of product risk strategy and documents as needed including RMP and REMS. Present at internal governance forums such as the Global Safety Leadership Committee (GSLC) and SRC, delivering strategic safety insights. Drive innovation in safety science, including the use of real-world evidence and advanced analytics Lead process improvements and contribute to the development of safety monitoring standards and tools. Mentor junior safety physicians and scientists and contribute to internal training and capability-building initiatives. Support inspection readiness and contribute to successful global regulatory submissions. Lead strategic planning for safety operations, including SOP updates, audits, and business continuity.
Basic qualification:
MD required; completion of residency or subspecialty fellowship preferred. Clinical experience in oncology, rheumatology, and/or neurology strongly preferred. Minimum 10+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration Experience with Cell or Gene Therapy, other immunotherapies (T-cell Engagers, Checkpoint Inhibitors) and/or Inflammation therapies preferred Proven ability to work in matrixed environments Advanced knowledge of global regulatory requirements (FDA, EMA, ICH, etc.). Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses) Familiarity with pharmacoepidemiology concepts and study design Proficiency in safety databases (e.g.,Argus) and signal detection tools (e.g., Empirica, Spotfire) Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset Demonstrated ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture
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: $255,425.00
- $330,550.
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.
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.
