Senior Director, Patient Safety

Senior Director, Patient Safety - TA Safety Physician page is loaded Senior Director, Patient Safety - TA Safety Physician
Bewerben locations United Kingdom - Cambridge posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R0039770 For Current Gilead Employees and Contractors:
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.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.
You will develop or oversee and ensure that strategic medical input relative to safety is incorporated into product development and lifecycle management as well as perform or oversee other advanced PS TA activities for a portfolio of products in the assigned therapeutic area.
You will provide strategic input into cross-functional drug development planning and execution across the product lifecycle, from discovery to postmarketing. You will ensure that signal detection, development of benefit-risk evaluation management plans, risk minimization activities, and aggregate safety reports are performed in a timely and quality manner. You will also provide input on behalf of PS TA into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, pharmacovigilance (PV) processes and projects and PV or other audits and inspections. You may be assigned responsibilities as a Global Safety Lead (GSL) or Global Safety Strategy Lead (GSSL) with responsibilities for managing a group of products/or indications and acting as the expert, strategic partner across Gilead regarding these compounds. Coaches direct reports on their performance, development and career interests.
Accountable for the successful oversight and completion of a broad spectrum of PS TA activities and deliverables for typically multiple products, compounds or indications in the assigned TA, in compliance with established practices, policies, processes, and any regulatory or other requirements.
Advises senior management on the PS TA strategy and pathway to achieve therapeutic area strategic milestones and objectives. 
May provide input into and influence cross-TA and Patient Safety (PS) strategies.
Performs or otherwise oversees safety reviews of clinical trial protocols, clinical study reports, informed consent forms, and other study related documents.
Provides and/or oversees medical input on PV activities for products within the assigned TA.
Authors, contributes to and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs).
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 the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.
Contributes to and/or oversees PS TA activities and input related to regulatory filings (e.g., Marketing Authorisation Applications [ MAAs], New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
Plays a leadership role on PS and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and PS TA functional area support in PV audits and inspections.
May serve as medical monitor for post-authorization safety studies.
Ensures the team and the assigned work comply with established practices, policies and processes and any regulatory or other requirements.
Education & Experience
Completion of an accredited medical or surgical residency program.
Experience leading cross-functional activities across a broad spectrum of drug safety or related programs, projects and other activities.
Experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
Line management (direct reports) experience is strongly preferred.
Proven track record of effective people leadership, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.
Rest of World Education & Experience
MD / DO or equivalent with completion of an accredited medical or surgical residency program. Significant experience working in drug safety / PV or a related field in the biopharma industry, clinical research, health administration, health policy, epidemiology, or academic or subspeciality medicine. 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).
Proven abilities to make significant contributions to Patient Safety (PS) strategic planning and lead significant process improvements in PS.
Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees. When needed, ability to travel.
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). For Current Gilead Employees and Contractors:
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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