Associate Director (AD) – Case Management and Strategic Partnerships

Aveo Oncology•Boston, MA

18d

About The Position

The Associate Director – Case Management and Strategic Partnerships provides operational leadership and oversight for outsourced ICSR processing, clinical trial and post-market safety operations, and PV alliance management within Global PV Operations. The role ensures vendor activities meet global pharmacovigilance requirements, study-specific safety reporting obligations, internal procedures, quality standards, contractual obligations, and processing timelines. The Associate Director evaluates vendor KPIs, operational metrics, and compliance trends to identify and escalate risks, address deficiencies, support CAPA, and drive sustainable process improvements. The position partners with PV leadership, cross-functional stakeholders, and external vendors to resolve case-related and operational issues, support data integrity and high-quality safety deliverables, strengthen the PV quality system, and maintain audit and inspection readiness. The role also provides technical guidance, governs PV procedures, supports change management and training, participates in audits and inspections, and develops and maintains PV agreements with business and license partners.

Requirements

U.S.-based.
Bachelor’s degree in a life science or healthcare-related field, such as biology, pharmacy, or nursing.
8+ years of progressively responsible pharmacovigilance experience in the biotechnology or pharmaceutical industry, encompassing clinical development and post-marketing safety operations, ICSR compliance, and increasing operational leadership responsibility.
5+ years leading oversight of outsourced PV vendors or service providers, including clinical trial case management, KPI and operational metric evaluation, contractual performance monitoring, risk escalation, and remediation of compliance deficiencies.
Demonstrated experience leading development, implementation, and maintenance of PV agreements with business and license partners, including defining safety responsibilities, reporting obligations, and operational interfaces.
Experience with Argus Safety and use of safety database outputs to oversee ICSR processing, reporting compliance, and vendor performance.
In-depth knowledge of global PV regulations and guidance, including FDA, EMA, and MHRA requirements, and ability to apply clinical trial and post-marketing safety reporting requirements, data integrity principles, and GxP quality standards to outsourced safety operations.
Demonstrated ability to translate PV requirements and operational priorities into effective SOPs, work instructions, and governance processes, and to lead related change management, training, and sustainable process improvements.
Experience supporting PV audits and inspections, evaluating compliance trends and operational risks, and guiding root cause analysis, CAPA, and remediation within a PV quality system.
Demonstrated cross-functional leadership and ability to influence internal stakeholders and external partners without direct reporting authority; strong judgment, technical communication, and prioritization skills to resolve complex issues and communicate risks and recommendations to PV leadership.

Nice To Haves

Experience establishing or enhancing global PV vendor governance frameworks, including risk-based oversight, performance scorecards, escalation pathways, and governance forums across multiple studies or products.
Experience leading cross-functional PV transformation initiatives, such as vendor transitions, operating model enhancements, or technology-enabled process improvements, with demonstrated improvements in compliance, efficiency, or reporting timeliness.
Advanced proficiency in Excel and experience with reporting or visualization tools to integrate vendor KPIs, compliance trends, and operational risk indicators into actionable management dashboards.
Experience representing PV Operations in senior-level vendor or alliance governance forums, presenting performance and risk assessments, and building stakeholder alignment on remediation priorities and operational decisions.

Responsibilities

Lead clinical trial and post-market case management vendor oversight within Global PV Operations, ensuring outsourced ICSR processing meets regulatory requirements, quality standards, contractual obligations, and processing timelines; escalate risks as needed.
Oversee external pharmacovigilance vendors by evaluating KPIs, operational metrics, and compliance performance; identify risks, address deficiencies, and drive continuous improvement.
Provide strategic oversight of clinical trial and post-market PV operations, ensuring vendor activities align with global PV requirements, internal procedures, and study-specific safety reporting obligations.
Provide operational leadership and technical guidance to support consistent execution, timely safety reporting, and high-quality PV deliverables.
Partner with internal and external stakeholders and vendors to strengthen compliance, resolve case issues and operational challenges, ensure source-to-database consistency, and maintain inspection-ready documentation.
Participate in PV audits and inspections and internal quality activities by providing case documentation and responding to safety-related requests.
Maintain compliance with global PV regulatory requirements and guidance and internal SOPs and work instructions; track and trend compliance findings as assigned and support CAPA where applicable.
Identify process gaps and operational inefficiencies and collaborate with stakeholders to develop and implement sustainable improvements.
Collaborate with the Director, PV Operations and Project Management, and the VP, Pharmacovigilance, to build and maintain the PV quality system, including gap assessments, departmental policies, SOPs, procedures, and job-related training.
Provide strategic direction and governance for PV SOPs, work instructions, templates, and policies, including procedures for outsourced safety activities; oversee their development, implementation, maintenance, refinement, change management, and supporting training.
Develop and maintain PV agreements with business and license partners.
Perform other duties as assigned.