Director, Safety Operations, Pharmacovigilance

Zenas BioPharma•Waltham, MA

4h•$188,000 - $235,000•Hybrid

About The Position

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation! Position Summary: The Director, Safety Operations, Pharmacovigilance is responsible for implementing and coordinating the PV department procedures, providing strategic direction and oversight of operations ensuring compliance with global PV regulations. This position represents the Pharmacovigilance department internally and externally at a global level. He/She supports all PV operations including but not limited to vendor selection process, vendor management, inspection readiness, KPIs and CAPAs related to PV operations, case processing metrics, SOP development and revision, and internal processes that support cross-functional PV initiatives.

Requirements

Bachelor’s degree in scientific related field preferred or combination education/experience
10+ years of PV experience in the pharmaceutical/biotech industry
Clinical trial product support and commercial product support experience preferred
Proven track record of leadership and operational excellence.
Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with other cross-functional groups.
Able to work independently, establish work priorities, and execute decisions with minimal guidance.
Experienced in global regulatory requirements for pharmacovigilance
Direct experience participating in regulatory authority inspections

Responsibilities

Lead effective vendor management strategies for PV.
Ensure PV department inspection ready.
Responsible for PV functional service provider (FSP) strategy and managing the selection process.
Responsible for developing a PV database strategy.
Provide Pharmacovigilance Operational support to clinical trial study teams and commercial products.
Serve as a subject matter expert for internal audits and global regulatory inspections.
Serves as key point of contact between PV and the CROs regarding PV operation management.
Communicates regularly with CROs and develops quality ICSR case processing and reporting metrics.
In conjunction with the compliance team, supports the escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions and the implementation of appropriate corrective actions, as needed.
Develops PV training plans and competency assessments for PV department.
Contributes to the development and maintenance of Safety Management Plans (SMPs).
Provides oversight and direction to direct report(s).