Senior Director, Inflammation TA Global Safety Leader

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 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

FUNCTION: Inflammation Therapeutic Area (TA) Global Safety Leader  

POSITION OVERVIEW:

The ideal candidate will lead and champion the voice of patients in development programs.  The candidate should be able to effectively strategize and implement benefit-risk activities across the product lifecycle. The candidate will also provide input into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, and pharmacovigilance processes and projects.  Furthermore, the candidate will mentor and develop his or her direct reports.

EXAMPLE RESPONSIBILITIES:

• Serves on cross-functional Global Development Teams as the safety expert, go-to-person, for safety profile of assigned products

• Ensures proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of assigned products

• Conducts and/or oversees signal detection and evaluation activities for assigned products as part of the continuous benefit-risk evaluation throughout the product lifecycle

• Supports implementation of decisions from safety governances, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.

• Provides global strategic input to management of potential safety issues and mitigation of safety risks

• Contributes to and/or oversees the preparation of aggregate safety reports, risk management plans (RMPs), and regulatory documents

• Communicates to senior management key pharmacovigilance findings

• Represents the Patient Safety at meetings with internal and external stakeholders

• Ensures own work complies with established practices, policies and processes, and regulatory requirements

• leads and manages a team of direct reports

• Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team.

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

MD / Pharm D or other advanced degree in clinical sciences with significant experience working in drug safety / PV or a related field in the biopharma industry, clinical research, health administration, health policy, or academic or subspeciality medicine. Clinical experience is preferred.

Knowledge & Other Requirements

• Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development).

• In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies.

• Strong knowledge of statistical methods used in PV.

• Proven abilities to make significant contributions to Patient Safety (PS) strategic planning and lead significant process improvements in PS.

• Exceptional 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. Able to distill complex matters into a clear business case and roadmap for execution.

• Strong negotiation and conflict resolution skills.

• Strong coaching capabilities to mentor/develop staff.

• When needed, ability to travel.

For jobs in the United States:

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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For jobs in France:

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