Director of Quality and Regulatory - Cambridge, Cambridgeshire, United Kingdom - Gilead Sciences, Inc.

Description

Director, Patient Safety - Established Products page is loaded Director, Patient Safety - Established Products
Bewerben locations United Kingdom - Cambridge time type Full time posted on Vor 24 Tagen ausgeschrieben job requisition id R

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 '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.
Medical Safety Science (MSS) / Global Therapeutic Area (TA) Safety Scientists

You will develop or oversee and ensure that strategic scientific input relative to safety is incorporated into product development and lifecycle management as well as perform or oversee other advanced MSS activities for one or more 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 MSS 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 the Global Safety Lead (GSL); acting as the expert, go-to person regarding the safety profile of a product/compound or group of products/compounds .

Accountable for the successful oversight and completion of a broad spectrum of MSS activities and deliverables for one or more products, compounds or indications in the assigned TA, in compliance with established practices, policies and processes, and any regulatory or other requirements.

Performs or otherwise oversees safety reviews of clinical trial protocols, Investigator's Brochures, clinical study reports, informed consent forms, and other study related documents.

Authors 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 MSS 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.

Participates on Global Patient Safety (GLPS) and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and MSS functional area support in PV audits and inspections.

Provides matrix management and leadership to project teams.
May serve as medical monitor for post-authorization safety studies.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

BA/BS or advanced degree in life sciences or related field with extensive experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment, including extensive experience working in drug safety / PV or a related field.

Expert 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 assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.

Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.

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:
Senior Director, Patient Safety - TA Safety Physician

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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