Associate Director, Patient Safety Risk Management Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We are seeking a highly motivated individual to join us as an Associate Director, Patient Safety Risk Management.
Under the guidance of the Executive Director of Kite Safety & Pharmacovigilance (PV), you are responsible for contributing to the initiation, management, and execution of key activities concerning the long-term benefit-risk assessment of cell therapy products. This individual will participate in the design and conduct of long-term follow-up clinical trials (LTFU), post-authorization safety studies (PASS), and global patient registries according to the evolving regulatory requirements, industry standards, and goals and vision of the organization. The candidate should be an expert in PV regulations and familiar with the interconnectedness of postmarketing safety and real-world evidence with other activities within pharmacovigilance and patient safety.
Key Accountabilities: Liaises with the Executive Director of Kite Safety & PV to execute the global and long-term goals for patient registries and post-marketing data. Serves as key contributor to the design, start-up, management, and execution of long-term follow-up clinical trials, post-authorization safety studies, and patient registries, accounting for current and evolving regulatory requirements, industry standards, and the goals and vision of the organization. Contributes to processes to ensure that global patient registries and post-marketing data work is compliant with all current regulations pertaining to post-marketing and clinical trial product safety, as well as company policies. Contributes to sections of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc.) and other key documents relevant to patient registries and post-authorization safety studies, in accordance with Kite/Gilead SOPs and global regulatory requirements. Prepares or contributes to responses to safety-related requests from health authorities. Contributes to budget planning and management for patient registries and post-marketing data. Liaises with the Kite and Gilead functions outside of Kite Safety who are responsible for noninterventional studies, real-world data collection and analysis, and generation and application of real-world evidence in support of the long-term benefit-risk assessment of cell therapy products. Liaises as needed with partner commercial organizations or academic consortia. Works with EU Qualified Person for Pharmacovigilance (QPPV) and other stakeholders to craft and fulfil EMA postmarketing commitments. May serve as representative on behalf Kite Safety & PV to Pharmacovigilance audits and inspections regarding patient registries and post-marketing data. Depending on professional qualifications, may serve as medical monitor for PASS, non-interventional or LTFU studies. May contribute to other pharmacovigilance departmental activities and key deliverables, including preparation of aggregate safety reports and risk management plans (RMPs) and signal detection and evaluation activities. Provides mentorship and contributes to the development of junior staff. Project Management--manage complex timelines using proven techniques to achieve on time completion with cross-functional collaboration and delivery of key documents. Basic Qualifications: PharmD/PhD in life sciences or related field and with 5+ years' significant relevant experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment, including significant experience working in drug safety/PV or a related field OR MA/MS/MBA in life sciences or related field and with 8+ years' significant relevant experience as noted above OR BA/BS in life sciences or related field and with 10+ years' significant relevant experience as noted above Preferred Qualifications: MD/DO or equivalent with significant relevant experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment, including significant experience working in drug safety/PV or a related field will also be considered. Significant drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical / healthcare environment. Significant experience in drug safety signal detection, benefit-risk evaluation and authoring drug safety risk management plans and aggregate safety reports is preferred. Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. Knowledge of worldwide PV regulations and their application to safety science. Thorough knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including all key functions involved in the various stages of drug development from early research through post-marketing. Demonstrates advanced scientific / clinical knowledge and analytical skills, as evidenced by strengths in assessing complex data sets and understanding the safety / clinical implications. Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner across functions. Demonstrated ability to work effectively in cross-functional teams and projects, as evidenced by past successful cross-functional collaboration. Strong interpersonal skills and understanding of team dynamics. Strong communication and writing skills, project management skills, and proficiencies with Microsoft Office suite, as evidenced through abilities to assume assignments and projects with increasing independence. Strong negotiation and conflict resolution skills. When needed, ability to travel. Experience using safety databases: e.g., RAVE, Argus, MedDRA, and WHO Drug. Extensive experience in signal detection, analysis, and management, particularly with respect to postmarketing safety data and real-world evidence, and preparing or contributing to periodic safety reports and other key safety documents. Previous experience managing or contributing to post-authorization safety studies and/or registry-based studies is preferred. Good knowledge of statistical methods used in PV. Understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies. The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us?
The salary range for this position is: $173,910.00 - $225,060.00. Gilead 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.
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