Develops or oversees and ensures that strategic scientific and regulatory input relative to safety is incorporated into signal management/signal detection processes as well as platforms/systems or oversees other advanced patient safety activities for the signal management process. Provides strategic input into signal management planning and execution across the product lifecycle, from discovery to post marketing. Provides signal management subject matter expert (SME) support to the PS TA on beha... more details
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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 empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description
Develops or oversees and ensures that strategic scientific and regulatory input relative to safety is incorporated into signal management/signal detection processes as well as platforms/systems or oversees other advanced patient safety activities for the signal management process. Provides strategic input into signal management planning and execution across the product lifecycle, from discovery to post marketing. Provides signal management subject matter expert (SME) support to the PS TA on behalf of Benefit-Risk Science and Process team (BRSP) into signal documentation and utilisation of the signal management system, PV processes and projects and PV or other audits and inspections. Is Gilead's signal management/signal detection SME, go-to person regarding process, systems, regulations, and best practices. May have one or more direct reports. Expected to play a lead role within BRSP; contributing to the ongoing and continuous improvement and advancing capabilities of the function.
EXAMPLE RESPONSIBILITIES:
Takes lead and is responsible for specific project(s), such as safety database support, safety systems validation, data-retrieval. Fully responsible for managing the tasks, timelines and resource allocation.
Participates in strategic systems planning, SOP updates, audits, data analysis and team meetings pertaining to their projects.
Accountable for the successful oversight and completion of a broad spectrum of BRSP activities and deliverables, in compliance with established practices, policies and processes, and any regulatory or other requirements.
Serves as a spokesperson for BRSP on significant matters relating to policies, programs, capabilities, and long-term goals and objectives.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience
PharmD/PhD with 6+ years’ relevant experience.
MA/MS/MBA with 8+ years’ relevant experience.
BA/BS with 10+ years’ relevant experience.
Extensive experience in drug safety signal detection, benefit-risk evaluation, and authoring drug safety risk management plans and aggregate PV reports.
Proven abilities to work independently, establishing work priorities and direction, make significant contributions to strategic planning and lead process improvements within Patient Safety, as evidenced by past successes effectively managing increasing scope and complexity.
Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
Rest of World Education & Experience
BA/BS or advanced degree in life sciences or related field with significant experience leading or co-leading large-scale, highly complex cross-functional work and projects in life sciences, including leading short- and long-range strategic planning, governance, and oversight.
Knowledge & Other Requirements
Recognized expert in PV, regulations, signal detection, clinical trials and clinical development.
Expert knowledge of the drug development process, GCP and GVP, including worldwide PV regulations and their application to safety science activities (signal detection, clinical trials and clinical development).
Expert knowledge of all key functions involved in the various stages of drug development from early research through post marketing.
Strong knowledge of statistical methods used in PV.
Demonstrates advanced leadership skills, as evidenced by past successes effectively setting short- and long-term team and project direction and leading projects and teams through successful execution.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
Strong negotiation and conflict resolution skills.
Strong coaching capabilities to mentor/develop staff.
When needed, ability to travel.
The salary range for this position is: $221,170.00 - $286,220.00. 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*.
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.
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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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
