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Director, Safety - Medical Device Vigilance Expert

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Nov 13, 2023

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Job Details

Director, Safety - Medical Device Vigilance Expert
United States - California - Foster CityUnited States - New Jersey - ParsippanyUnited States - Washington - Seattle

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


Job Description


Job Description
Director, Safety - Process Optimization & Training: Medical Device Vigilance Expert

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.

The Patient Safety (PS) department is a global function that is part of the Development organization within Gilead. The main Pharmacovigilance activities of PS are centred at three sites: Foster City and Santa Monica in the USA and Cambridge in the UK.

This role sits in the PS Strategic Operations team responsible for review of PV-related policies and global regulations, PV Agreements, Distributors, Solicited Programs and REMS, operational support of clinical studies, audit and inspection readiness/support, training, and ICSR excellence.

The role will be office based on our site in Cambridge, UK.

Gilead Sciences is seeking an ambitious individual to join the Strategic Operations team as a Director responsible for Medical Device Vigilance Excellence, including country specific medical device and combination rule regulation, as well as in vitro diagnostic regulation (IVDR). We are seeking a PV and device expert to execute strategy and ensure operational excellence in the following areas:
  • Leading activities related to Drug Device Combination product excellence within Patient Safety with regards to Gilead's current and future product strategy. Working within PS and cross-functionally with regards to current and future device vigilance and reporting, identifying any process gaps. The role would involve working with PS Therapeutic Areas to establish a process for trending and signal management of device complaints.


You will provide expertise to multiple stakeholders working closely with colleagues in various groups within Patient Safety, Manufacturing, Quality Assurance, Legal and Regulatory Affairs. The role would suit someone with strong strategic thinking, communication and analytical skills, a broad PV and device vigilance experience and an enthusiasm for understanding the business needs.

Core responsibilities include, but are not limited to the following:
  • Understanding and awareness of global drug device combination product regulations, especially EU and US specific requirements with regards to handling, evaluating, and investigating device reports
  • Lead and work with PS cross functional working group to interpret, assess impact and update process and procedures with regards to device regulations requirements and updates as required
  • Work with Patient Safety TAs to define process for assessment of device complaints, as well as trending and signal management
  • Working with QA to understand process for management, assessment and reporting of device complaints
  • Assessment and gap analysis of the new device regulations and products and implement process updates as required
  • Assessment and gap analysis of software as a medical device and how they impact Gilead processes
  • Working with the PS Affiliate leads regarding local regulation requirements and coordinating globally
  • Represent PS in cross functional working groups and teams as required with regards to Device Regulations and IVDR and its impact to PS
  • Link with PS PV Alliances team regarding specific requirements needed in PV agreements with License Partners.


Job Skills:
  • Identifies and pursues global and long-term goals for the group, in collaboration with team head, taking into account and providing support for the strategic goals of the organization
  • Demonstrates excellent verbal and written communication skills; has ability to provide direction to a team, and to influence peers and team members appropriately.
  • Develops solutions to a wide range of complex problems which require the regular use of ingenuity, creativity, and innovation, ensuring solutions are consistent with organization objectives; develops concepts, techniques, standards, and new applications based on professional principles and theories; viewed as an expert within the organization
  • Serves as consultant to PS management in area of expertise and acts as a spokesperson for the PS organization in matters pertaining to its policies, plans, and long-term goals and objectives.
  • Reviews new regulatory requirements in area of responsibility, makes recommendations based on impact to existing processes and oversees implementation.
  • Maintains knowledge of company disease and therapeutic areas
  • Recognizes potential or impending problems, implements and delivers solutions.
  • Contributes to department strategic planning, SOP creation and updates for PS, review and critique audits and data analysis pertaining to their projects or the wider PS organization, manages corrective actions and highlights concerns to PS management
  • Makes and effects decisions that are long-lasting and influence the future course of the PS organization.


Education and Experience: At a minimum, the ideal candidate will possess
  • Scientific background with a medico-scientific university degree
  • Previous strong experience in multiple aspects of pharmacovigilance and device vigilance activities
  • Project management experience preferred or experience in managing complex projects
  • Resource and workload management experience
  • Has an excellent knowledge and understanding of applicable regulatory requirements.


The Gilead Difference

Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it's just what we do that gives us an edge, it's how we do it. We expect everyone at Gilead to lead by example, guided by our core values:
  • Integrity (always doing the right thing)
  • Teamwork (collaborating in good faith)
  • Excellence (working at a high level of commitment and capability)
  • Accountability (taking personal responsibility)
  • Inclusion (encouraging diversity)


The salary range for this position is: $214,795.00 - $277,970.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 Current Gilead Employees and Contractors:


Please log onto your Internal Career Site to apply for this job.






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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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