Assoc Director, Patient Safety RM

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.

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Job Description

The Associate Director Patient Safety provides strategic pharmacovigilance leadership for one or more products compounds or indications across the development and/or post marketing lifecycle. This role contributes safety expertise to ensure continuous evaluation of benefitrisk profiles regulatory compliance and patient safety while serving as a key Patient Safety representative on cross functional teams.
The Associate Director operates with a high level of autonomy partnering across functions to support product development lifecycle management and post authorization safety activities.

Key Responsibilities

• Provide scientific input into pharmacovigilance activities including safety surveillance signal detection and evaluation and benefitrisk assessments for assigned products and assisting with pharmacovigilance activities for other products when needed.

• Contribute to the development and execution of safety strategies across the product lifecycle from clinical development through postmarketing.

• Provide input into aggregate safety reports (e.g. PSURs/PBRERs DSURs) regulatory submissions and responses to health authority inquiries.

• Support risk management activities including Risk Management Plans risk minimization measures and safetyrelated labeling updates.

• Provide safety leadership and review of clinical study protocols amendments and studyrelated documents.

• Serve where applicable as a medical monitor for postauthorization Phase 4 or observational studies including investigatorinitiated and collaborative research.

• Represent Patient Safety on crossfunctional teams collaborating with Clinical Development Regulatory Affairs Medical Affairs RWE/HEOR and other functions.

• Ensure pharmacovigilance activities are conducted in compliance with global regulations internal SOPs and quality standards.

• Contribute to inspection readiness process improvement initiatives and the ongoing enhancement of Patient Safety operating models.

• Build effective working relationships and provide thoughtful safety input to internal stakeholders to support patientcentric decisionmaking.

Basic Qualifications

• Advanced degree in a scientific or medical discipline (e.g. MD PharmD PhD or equivalent).

• Relevant experience in pharmacovigilance / patient safety within the pharmaceutical or biotechnology industry.

• Working knowledge of global pharmacovigilance regulations and aggregate safety reporting requirements.

• Demonstrated ability to evaluate safety data apply clinical judgment and communicate benefitrisk considerations.

• Experience working effectively in crossfunctional matrix environments.

Preferred Qualifications

• Experience supporting safety oversight for products across multiple stages of the development or postmarketing lifecycle.

• Prior involvement in safety signal evaluation risk management activities and regulatory interactions.

• Strong written and verbal communication skills with the ability to present complex safety information to diverse stakeholders.

• Ability to manage multiple priorities and products concurrently in a fastpaced environment.

Equal Employment Opportunity (EEO)

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 individuals 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). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.