• 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.