Vice President, Pharmacovigilance and Patient Safety Remote

Overview

Remote - United States

VICE PRESIDENT, PHARMACOVIGILANCE AND PATIENT SAFETY

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned.

POSITION SUMMARY

The Vice President, Pharmacovigilance and Patient Safety will join as a pivotal member of the Research and Development senior leadership team and play a significant role in managing the multiple facets of drug safety and pharmacovigilance focused on product development as the Company continues to scale and grow. This individual will report to the Chief Medical Officer (CMO) and will work in close collaboration with the Head of Research and Development (R&D).

The Vice President, Pharmacovigilance and Patient Safety will provide leadership to the Pharmacovigilance and Patient Safety (PPS) Team, working cross-functionally as well as with external functions and regulatory authorities, to lead and direct the oversight of clinical safety, risk management, and compliance with pre- and post-marketing regulations. This includes assuring compliance of all clinical studies in accordance with domestic and international requirements for drug safety oversight and reporting through late-stage development, licensure, and commercialization in the U.S., Europe, and other regions.

This position will have a high degree of visibility and impact across the organization and will collaborate closely with other executive team members to provide equivalent support to the Pharmacovigilance/Safety Surveillance and to the Clinical Development/Regulatory/Operations/Systems/QMS groups.

Day One Bio is preparing and planning for significant growth and the Vice President will possess the strategic and people skills to work effectively in a dynamic, cross-functional, growing organization. This role will assume leadership of a strong existing team of safety operations and medical personnel and oversee pharmacovigilance activities at the operational, product, enterprise and external alliance management levels.

This position has the potential to be fully remote. Occasional travel will be required for in person meetings.

• Serve as the subject matter expert (SME) on global drug safety requirements in all phases of drug development and post-market support, providing leadership in the transition from a clinical stage company into an organization encompassing global post-market drug safety and risk management.
• Represent the Pharmacovigilance and Patient Safety Department across all Day One Bio programs.
• Lead and oversee the fundamental activities of Safety Operations including continuous safety data collection and compliant regulatory reporting.
• Lead and oversee Pharmacovigilance signal detection, risk management activities and risk mitigation strategies throughout the lifecycle of Day One Bio’s products.
• Provide oversight and management of pharmacovigilance agreements (PVAs) and relationship management with Development Partners.

• Ensure ongoing evaluation of the overall safety profile for all of Day One Bio's investigational products and regular presentation of safety data in cross-departmental safety review meetings.
• Identify matters that need escalation to senior leadership via internal safety governance processes.
• In coordination with Regulatory Affairs, plan and support safety input into regulatory submissions including registration product applications and product labeling for the safety sections of the assigned products and indications (e.g., CCSI, USPI).
• Represent the company at Safety meetings and lead responses to and/or resolution of regulatory safety enquiries from regulatory agencies and health authorities.
• Serve as Standing member and Deputy Chair of the Safety Review Board for Safety Governance.
• Member of the Senior Leadership Team (SLT).

• Provide…