Senior Director, Global Oncology Therapeutic Area Safety Physician

Senior Director, Global Oncology Therapeutic Area Safety Physician

Gilead

Cambridge, United Kingdom

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;
  • 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.

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