Director, Country Operations Management

AstraZeneca•Boston, MA

7d•$171,622 - $227,434•Hybrid

About The Position

The Director, Country Operations Management (DCOM) leads a local execution team and is accountable for the quality and delivery of assigned clinical trial programs in the country. The role ensures study deliverables are completed according to timelines, operational procedures, quality standards, SOPs, guidelines, local regulations, ICH/GCP, and country-level ways of working, with a focus on timely and cost-effective delivery. The DCOM contributes to country-level deliverables across early planning, feasibility, site selection, study start-up, enrollment, data delivery, and close-out, partnering with global study teams and relevant country and regional functions to define those deliverables. The role leads, manages, trains, and develops direct reports; plans and optimizes reporting resources; sets objectives; follows up on performance; and helps standardize country processes and manage change. The DCOM maintains oversight of vendors, including CROs, and establishes effective communication with country stakeholders such as Medical Affairs and Legal where applicable. The position also supports clinical program strategy, manages risks and issues, promotes inspection readiness and compliance, and drives continuous improvement in country execution.

Requirements

At least 7 years of clinical research experience, including experience developing and managing a clinical operations function and managing staff in a pharmaceutical and/or biotechnology environment.
Experience with internal delivery of global clinical trials and proven excellence in operational delivery of clinical operations activities across multiple projects.
Previous direct line management experience.
Experience leading, developing, and implementing functional and cross-functional teams, SOPs, and processes.
Deep knowledge of global regulatory requirements and ICH/GCP guidelines.
Demonstrated proficiency in implementing, monitoring, and managing clinical trials.
Deep knowledge of therapeutic-area operational delivery, the country clinical trial environment, and the rare disease landscape.
Ability to prioritize, meet deadlines, and manage competing priorities and changing demands.
Ability to build, coach, mentor, motivate, and supervise a high-performing team in a dynamic company, including clarifying roles and responsibilities.
Ability to establish strong internal and external relationships, including with alliance partners and vendors.
Strong planning and budgeting skills.
Superior written, oral, and presentation skills.
Ability to lead in a matrix environment.
Excellent project management and administrative skills.
Excellent interpersonal skills across countries, cultures, and organizational functions, with well-developed problem-solving, organizational, and negotiating skills.
Availability for domestic and international travel up to 25%, depending on program progress.
Bachelor’s-level degree.

Nice To Haves

Previous field CRA experience.
Experience running clinical studies for ultra-rare diseases and developing and implementing innovative solutions to optimize their conduct.
Experience with adult and pediatric clinical research across various therapeutic areas in the US.
Master’s or doctoral degree, or equivalent, in a scientific discipline.

Responsibilities

Lead the local execution team for assigned programs in line with country-level ways of working.
Use available technology to manage local study delivery and identify opportunities for operational optimization.
Direct the country execution team to deliver quality and timely study work, including site identification, feasibility, start-up, recruitment, and data deliverables.
Optimize assigned team resources to meet committed clinical program targets.
Develop and performance-manage direct reports, ensure development and training plans are in place, and provide regular hands-on support and coaching.
Participate in succession planning and talent development discussions.
Prepare salary and bonus proposals for direct reports based on performance, in consultation with SDHCO and local HRBPs.
Contribute to transformation initiatives, standardize country-level processes, and manage change to support an effective COM organization.
Monitor metrics and Key Performance Indicators across studies.
Promote cross-functional collaboration through proactive communication with global and local study team members, raising and resolving study-specific blockers quickly.
Partner with Development Country Quality and Medical Advisor Pipeline to support quality mindset, inspection readiness, and site engagement.
Contribute to high-quality feasibility work using data, local intelligence, and site insights to develop credible plans and country commitments aligned with country goals.
Oversee local team member interactions with IRBs and Ethics Committees.
Approve site selections for each study.
Ensure timely and complete eTMF documentation.
Ensure a post-trial access plan is in place as part of study completion.
Ensure local study team members and contract workers, including FSP staff, comply with Alexion SOPs.
Connect proactively with other country leaders to share issues and learnings in support of the COM organization.
Manage internal and external stakeholders and support local country strategies in collaboration with Medical Affairs, Regulatory, and AZ SMM colleagues.
Manage country and local study-level risks, issues, and decisions, escalating appropriately to SD HCO.
Develop expertise in analyzing and resolving study execution and compliance issues in a changing clinical trial environment.
Ensure execution teams are appropriately qualified and trained for their roles.
Drive continuous improvement and team performance using global, regional, and country performance metrics.
Identify performance issues and opportunities for continuous improvement.