Director, Safety Science - Cambridge, United Kingdom - Gilead Sciences International, Ltd.

Description

Description

POSITION OVERVIEW:
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:

•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.

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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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