Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Serves as a senior scientific and clinical expert for safety profile of products in therapeutic areas

Defines global product safety strategy and routinely manages and leads functional and cross-functional projects

Works under consultative direction towards long-term GLPS goals and objectives; assignments are self-initiated with almost no direct supervision

Serves on senior-level cross-functional teams

Communicates to highest levels of senior management key pharmacovigilance findings

Provides global medical leadership for product-focused safety activities

Provides global strategic input to the organization to mitigate pharmacovigilance-related risk

Executes process changes and initiatives based on deep understanding of good pharmacovigilance practices (GVP) and other regulatory guidance

Participates in standard operating procedure (SOP) updates, audits, data analysis, and other ad hoc activities

Collaborates 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 issues

Essential 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

Requirements:

MD/ DO degree or equivalent. Completion of an accredited medical or surgical residency program is required. Board certification is preferred.

6+ years (with MD) or 12+ years (with PharmD) in pharmacovigilance 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 is strongly preferred

Possesses solid understanding of pharmacoepidemiology and ability to provide a sound critique of observational studies

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