Senior Director, Inflammation TA Global Safety Leader

Gilead

Cambridge, United Kingdom

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.

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