Director, Pharmacovigilance Operations & Quality

Position Purpose

We are seeking a Sr. Director, PV Operations & Compliance to create, direct and manage the company's PV infrastructure in support of its first commercial product for a first-in-class antisense oligonucleotide (ASO) therapy in a rare pediatric neurological disease. This is a newly created role and a genuine opportunity to shape the scientific infrastructure of the PV department at a critical inflection point.

This position is accountable for PV operations for Stoke, including oversight of safety operations across the portfolio including case processing, database strategy, vendor oversight & governance, inspection readiness, contracts, training and operational strategies related to safety data exchange agreements for the company's business partners and alliances. The role is best suited for someone who is comfortable operating in a small, fast-paced biotech environment. This position reports to the Vice President, Pharmacovigilance.

Key Responsibilities

• Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.
• Direct the development of the PV quality management system including SOPs, Work Instructions, and other guidance documents, in collaboration with internal PV and Quality personnel.
• Establish and maintain oversight and coordination of PV activities (e.g., contracts, safety data exchange agreements, training, reconciliation related to organized data collection systems used by the company).
• Own the strategic design and implementation of the company's PV training program, spanning internal staff, field staff and external partners with role-specific content.
• Partner with Legal, Compliance, Commercial and Medical Affairs to embed training requirements into vendor contracts and onboarding, with KPIs to track effectiveness through commercial launch and beyond.
• Lead effective vendor management strategies for PV-related activities.
• Develop effective business models optimizing internal and contract resources and ensure adequate documentation of vendor oversight.
• Establish and oversee implementation of company standards related to post-marketing surveillance, track productivity and monitor quality/cost of outsourced activities related to AE case processing.
• Lead development and maintenance of compliance monitoring systems including metrics tracking for activities in PV.
• Establish processes, tools and tracking mechanisms for PV department deviations ensuring appropriate corrective and preventative actions are in place with timely resolution of findings.
• Hire, manage and supervise activities of direct reports; conduct ongoing performance reviews and development of staff.
• Ensure compliance with global PV regulations and reporting requirements.
• Oversee operational support for DSURs, PBRERs/PSURs, PADERs, and other safety deliverables.
• Responsible for PV budgets, MSA and SOW with PV vendors.
• Contribute to inspection readiness for Stoke's pharmacovigilance function.

Required Skills & Experience

• Bachelor's degree in life sciences/pharmacy/nursing degree or related field; advanced degree (MS, PharmD or equivalent) preferred.
• Minimum of 12 years of progressive responsible pharmacovigilance experience including a combination of PV operations and PV quality experience; minimum of 5 years in a leadership role.
• Significant experience with outsourced operating models and vendor governance.
• Experience in PV processes for vendor oversight, individual case handling, aggregate reports, and audits/inspections.
• Experience leading and contributing to process improvements, quality management systems, inspection readiness, Health Authority audits, SDEA negotiations.
• Proven track record building internal PV operations/compliance capabilities in a fast-paced, innovative environment.
• Deep knowledge of global PV regulations, GVP, FDA regulations, and ICH guidelines.
• Experience and extensive working knowledge of MedDRA, WHODrug, and safety databases (e.g., Argus, ARISg).
• Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail.
• Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.