Director, Safety Science

Location
Remote, United States
Posted
Nov 12, 2021
Ref
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Required Education
Bachelors Degree
Position Type
Full time

Locations: Remote, United States | Hayward, California | Brisbane, California

Summary

The Director of Safety Science will serve as a safety expert accountable for the global safety strategy and safety profile for the assigned product(s) throughout the product’s lifecycle and will provide strategic and operational Safety Science support for Arcus’s developmental products in close collaboration with other Safety and Medical staff.  This individual must be able to work effectively in a matrix, with multiple other departments across the organization, and with external stakeholders such as Investigators and Regulatory Agencies.  This position will report to the Sr. Medical Director, Safety.

Responsibilities

  • Oversight of day-to-day safety monitoring activities and safety data for the assigned product
  • Review and synthesis of individual case reports as well as aggregate data summaries
  • Provide safety science and pharmacovigilance subject matter expertise on program and study teams as well as other cross-functional platforms throughout the company
  • Facilitate cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
  • Review and provide PV input to all core clinical documents including protocols, IBs, ICFs, and CSRs
  • Authoring of aggregate safety reports, e.g., DSURs, PSURs
  • Provide subject matter expertise and input for regulatory responses and submissions
  • Assist the Sr. Medical Director in building core PV capabilities and processes for the department

Qualifications

  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
  • 8+ years’ pharmaceutical industry experience, including 5+ years’ experience in PV
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data; oncology experience is preferred
  • Experience in the preparation and authoring of pre- and post- aggregate safety reports
  • Thorough understanding of the drug development process and context applicable to safety surveillance activities
  • Ability to execute and follow-through to completion and documentation
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem-solving ability
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Excellent oral and written communication skills and the ability to work and influence cross-functionally
  • Solid foundation in GCP and GVP regulations
  • Track record of strong personal performance combined with demonstrated ability to build and lead a high performing team.