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Assoc Director, Patient Safety Medical Device Safety

Parsippany-Troy Hills, United States

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.

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Patient Safety is seeking a dynamic and experienced individual to join the Patient Safety Strategic Operations team as an Associate Director, Patient Safety Medical Device Safety responsible for supporting activities to ensure ongoing safety oversight of Gilead’s medical devices and combination products throughout the product lifecycle. These activities include but are not limited to ensuring compliant global processes for vigilance/safety reporting, post-market surveillance system, trending of device complaints, risk management, and analysis of safety data sets covering Gilead medical device and combination product portfolio. This role will help drive strategies and ensure operational excellence through successful business partner collaboration.
The Associate Director, PS Medical Device Safety will be a medical device / combination product expert who supports safety oversight and provides technical contributions to design control, risk management, clinical evaluations, vigilance/safety reporting, post-market surveillance and trending / signal management for medical devices and combination products worldwide. The role would suit someone with passion for patient safety, strong strategic thinking, communication and analytical skills, broad PV and medical device / combination product experience and an enthusiasm for understanding the business needs.
Key Responsibilities
Responsibilities include, but are not limited to:
  • Ensure safety processes are executed and maintained throughout the product lifecycle in compliance with relevant regulations, standards, and guidelines for medical devices, combination products and diagnostics.
  • Review device cases / complaints to ensure that case processing and evaluation are accurate and in compliance with regulatory requirements for safety reporting and Gilead standards. Closely collaborate with ICSR and Product Complaint teams to resolve any issues, inconsistencies or inaccuracies identified between the Global Safety database and Quality database.
  • Develop training and standards for case processing and safety reporting.
  • Contribute to medical device / combination product Post-Market Surveillance (PMS), including planning and report preparation. Support writing, review, and submission of applicable device contribution in aggregate reports (PSUR/PBRER, PADER).
  • Collaborate with PS Therapeutic Area leads and PS Benefit-Risk Science teams to conduct safety assessments of data sets including device complaints, as well as device trending and signal management for combination products.
  • Provide device safety contribution and collaborate with PS Therapeutic Area leads in combination product development and clinical studies.
  • Collaborate with cross-functional team in device risk management activities including identification and reduction of risks associated with Gilead’s medical devices / combination products, conducting benefit-risk analysis, and evaluating overall residual risk acceptability throughout the lifecycle of the product.
  • Review regulatory intelligence and work with PS cross functional team to interpret, assess impact, and update processes and procedures with regards to device / combination product regulations requirements and updates as required.
  • Collaborate with PS Affiliate leads regarding local regulatory requirements and coordinate globally.
  • Represent PS in cross functional working groups and teams with regards to device / combination product / diagnostic regulations and its impact to PS.
  • Link with PS Alliances team regarding device requirements needed in PV agreements with License Partners.
  • Collaborate with cross-functional teams in the preparation and/or support of internal audits and regulatory agency inspections; reviews, responds and implement corrective and preventive actions with respect to findings on PS processes for medical device / combination product.
  • Develop solutions to a wide range of complex problems, ensuring solutions are consistent with organization objectives.
  • Foster a culture of collaboration and communication to drive business objectives.
  • Drive a culture of continuous improvement to enhance PS processes and safety oversight.
  • Stay abreast of industry trends, emerging topics, and best practices in the medical device / combination product space.
Basic Qualifications
  • BA/BS with 10+ years’ relevant experience OR
  • MA/MS/MBA with 8+ years’ relevant experience OR
  • PhD/PharmD with 5+ years’ relevant experience
Preferred Qualifications
  • Health care professional degree preferably Nursing or Biomedical Engineering degree.
  • Extensive medical device / combination product safety or related experience. Previous experience in pharmacovigilance and device safety activities.
  • Thorough understanding and application of medical device / combination product regulations and industry standards globally for design control, device risk management, vigilance / safety reporting, and post-market surveillance throughout the product lifecycle. Experience translating these requirements into medical device safety processes, in particular risk management, device vigilance / safety reporting and post-market surveillance preferred.
  • Significant experience in navigating a matrix organization.
  • Track record of successfully leading complex, large scale, time-sensitive projects.
  • Strong relationship building skills, and ability to collaborate, influence and negotiate to work effectively with cross-functional teams to meet project timelines and patient needs.
  • Excellent verbal, written, and interpersonal communication skills. Ability to write clear and concise documents/presentations.
  • Ability to prioritize and manage across multiple competing projects.
  • When needed, ability to travel.

The salary range for this position is:
Other US Locations: $177,905.00 - $230,230.00.
Bay Area: $195,670.00 - $253,220.00.

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

For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 for assistance.

For more information about equal employment opportunity protections, please view the
'Know Your Rights'
poster.
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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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 apply via the Internal Career Opportunities portal in Workday.

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