Gilead Sciences, Inc

Establishes the direction of pharmacovigilance activities for assigned products and provides global medical leadership and input into all aspects of safety of assigned molecules within the Oncology TA including surveillance programs, aggregate review, and risk management planning.. 6+ years (with MD or PharmD) in pharmacovigilance, drug development or applicable role in the pharmaceutical industry with significant knowledge of relevant regulatory requirements and substantial knowledge of drug safety including previous experience in a leadership role in the pharmaceutical industry.. Experience in Hematology/ Oncology / Immunology is preferred.. Possesses significant knowledge of EU and FDA pharmacovigilance guidelines, good clinical practice (GCP), and clinical research methodology.. Establishes recognition as a clinical and scientific expert on project and cross-functional teams and “end-line” decision maker for product safety decisions on behalf of GLPS.Demonstrates ability to independently lead crisis management scenarios.

senior director

Description Serves as a senior scientific and clinical expert for safety profile of products in therapeutic areasDefines global product safety strategy and routinely manages and leads functional and cross-functional projectsWorks under consultative direction towards long-term GLPS goals and objectives; assignments are self-initiated with almost no direct supervisionServes on senior-level cross-functional teamsCommunicates to highest levels of senior management key pharmacovigilance findingsProvides global medical leadership for product-focused safety activitiesProvides global strategic input to the organization to mitigate pharmacovigilance-related riskExecutes process changes and initiatives based on deep understanding of good pharmacovigilance practices (GVP) and other regulatory guidanceParticipates in standard operating procedure (SOP) updates, audits, data analysis, and other ad hoc activitiesCollaborates with Medical Safety Science- Global TA Safety Scientists in proactive identification and assessment of safety signals and trends, and supports management of any potential safety issuesEssential Duties:Oversees clinical development and medical safety support for all project related activities for multiple products.Provides medical strategy and input into key regulatory decisions pertaining to the safety of multiple products, including representing the GLPS Department at advisory panels and meetings with regulators or other internal and external stakeholders.Establishes the direction of pharmacovigilance activities for assigned products and provides global medical leadership and input into all aspects of safety of assigned molecules within the Oncology TA including surveillance programs, aggregate review, and risk management planning.Leads a portion of BLA submission activities.Requirements:MD/ DO / Pharm D degree or equivalent. Completion of an accredited medical or surgical residency program is required. Board certification is preferred.6+ years (with MD or PharmD) in pharmacovigilance, drug development or applicable role in the pharmaceutical industry with significant knowledge of relevant regulatory requirements and substantial knowledge of drug safety including previous experience in a leadership role in the pharmaceutical industry.Experience in Hematology/ Oncology / Immunology is preferred.Experience in a basic science laboratory and/or proficiency in translational research is preferred.Experience in submission of BLA/NDA is preferred.Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications.Possesses significant knowledge of EU and FDA pharmacovigilance guidelines, good clinical practice (GCP), and clinical research methodology.Establishes recognition as a clinical and scientific expert on project and cross-functional teams and “end-line” decision maker for product safety decisions on behalf of GLPS.Demonstrates ability to independently lead crisis management scenarios.Demonstrates ability to self-initiate pharmacovigilance processes.Experience in a basic science laboratory and/or proficiency in translational research is preferred.Experience in submission of BLA/NDA is preferred.The salary range for this position is: $274,635.00 - $355,410.00. 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: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 for assistance.

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