Senior Director, Patient Safety (MD)

Kite Pharma•Parsippany, NJ

3d•$255,425 - $330,550•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Completion of residency or subspecialty fellowship preferred.
Clinical experience in oncology, rheumatology, and/or neurology strongly preferred.
Experience with Cell or Gene Therapy, other immunotherapies (T-cell Engagers, Checkpoint Inhibitors) and/or Inflammation therapies preferred.

Responsibilities

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).
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).
Responsible for recommending appropriate safety monitoring measures for safety issues.
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.
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.
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.
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.