Arcus Biosciences, Inc. Hayward , CA 94542
Posted 2 months ago
The Director, PV 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. This role 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 Senior Director, PV Science.
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. Director, PV Science 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
Ability to work and influence cross-functionally
Solid foundation in GCP and GVP regulations
This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $213,000 - $250,000. For remote-based candidates, the salary range may vary based on local market data. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers/.
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets.
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Arcus Biosciences, Inc.