Director, Safety Science (non-MD)

Director, Safety Science (non-MD)

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Locations : United States - California - Foster City

Time Type : Full time

Posted on : Vor 10 Tagen ausgeschrieben

Job Requisition ID : R0040609

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.

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 utilization 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 :

Develops solutions to a wide range of complex problems which require regular use of ingenuity, creativity, and innovation;

ensuring solutions are consistent with safety science and broader Gilead objectives and processes.

• Applies comprehensive understanding of procedures and practices within own discipline and emerging knowledge of related disciplines to resolve issues.
• Integrates technical / functional expertise with business / commercial knowledge through participation and coordination across cross-functional groups.
• Directs the resolution of highly complex or unusual business problems by applying advanced analytical thought and judgment.
• Coaches others leaders in resolving problems.
• Partners with stakeholders to implement and support drug safety computerized systems in accordance with regulatory requirements and Gilead business practices.
• Demonstrates project management skills and knowledge of project management tools.
• Must be proficient in written and verbal communication.
• 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.
• Understands relational databases and reporting tools.
• Works independently on long-range goals, with consultative directions only.
• Ensure teams are in compliance with all reporting requirements, guidelines, and SOPs to partners and regulators.
• Create learning plans and recommends training and development solutions and provides mentoring and coaching as appropriate.
• Influences the long-term strategy for signal management / signal detection.
• 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.
• Works on complex problems and provides solutions that have significant impact.
• Typically plays a lead role in special projects, such as continuous improvement and optimization initiatives across safety science.
• Serves as a spokesperson for BRSP on significant matters relating to policies, programs, capabilities, and long-term goals and objectives.
• Recognized as a key representative for the conduct and oversight of the full spectrum of BRSP activities in support of patient safety and TA strategies, goals, and objectives.
• Represents Gilead at external professional meetings or discussions with industry trade groups.

REQUIREMENTS :

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 drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical / healthcare environment.
• 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.
• Proven track record of successfully managing large scale, complex, time-sensitive projects.

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

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