Associate Director, Country Operations Management

AstraZeneca • Boston, MA

29d • Hybrid

About The Position

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. The Role: As Associate Director, Country Operations Management (AD COM), you will report to the Head of Country Operations and play a central role in implementing the country strategy. You will serve as a culture and values ambassador and act as the line manager for designated local functions, as agreed with the Head of Country Operations. You will be accountable for the successful delivery of all assigned operational trial activities across programs—whether managed directly by you or by your team—ensuring timelines, operational procedures, quality standards, SOPs, and guidelines are consistently met. In this role, you will lead the day‑to-day management of one or more dedicated functional groups within the local Country Operations Management team. You will oversee planning and resource utilization, set objectives, drive performance development, and ensure your direct reports meet study expectations. You may also contribute to regional and global initiatives as delegated. In some countries, the AD COM may take on additional responsibilities—such as Project Manager, Country Operations (PMCO)—as needed and agreed with the Head of Country Operations.

Requirements

• Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 8 ( 5 for LM of CRAs only) years of experience in Development Operations (CRA / Sr. CRA / Project management) or other related fields.
• Strong leadership to drive team growth, development and support the local COM strategy implementation
• Pro-active identification of requirements to support future needs
• Business acumen to understand company direction and drive the understanding at team level
• Solution oriented attitude and ability to lead through ambiguity
• Excellent interpersonal skills, proactivity and assertiveness.
• Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
• Excellent organizational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.
• Excellent knowledge of spoken and written English.
• Ability for national and international travel.
• Integrity and high ethical standards.

Nice To Haves

• Line management experience and good resource management skills
• Prior CRA experience
• Excellent knowledge of the Monitoring Process.
• Good understanding of the Study Drug Handling Process and the Data Management Process.
• Ability to work in an environment of remote collaborators.
• Excellent decision-making skills.
• Good conflict management skills and ability to handle crisis.
• Excellent team building skills also in cross-functional teams.
• Good intercultural awareness.

Responsibilities

• Leading and developing of the dedicated functional group within Country Operations Management at local level.
• Ensures adequate resources for the studies assigned, ensure that workload of direct reports is optimized, and ensures appropriate and timely assignment to projects by liaising with relevant stakeholders (HCO, PMCO, global study team, etc).
• Development and performance management of direct reports, including implementation of development and training plan and regular coaching of the direct reports.
• Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible HCO
• Manages new staff interviews, hiring, onboarding process, for full-time and and in-sourced staff
• Ensures that study activities at country level comply with local policies and code of ethics, and ensures team delivery to committed activation and recruitment targets
• Contribute to Country feasibility analysis for new potential clinical trials (as applicable, depending on the direct reports the LM will be managing). Support the Country external scientific engagement strategy and action plan.
• Contribute to efficient COM organization and its functioning at country level by working closely with responsible HCO.
• Support HCO and in-Country COM activities as agreed with HCO, such as Site Oversight Visit reports review (as applicable, depending on the direct reports the LM will be managing) and onboarding and training of new in-Country COM functions and team members
• Act as extended local leadership team member with accountability to support the Country strategy implementation, champion the company values and support HCO with the local affiliate and global DRS team cross-functional interactions required to support local COM goals.
• Contribute to the quality improvement of the study processes and other procedures through close partnership with DCQ at Country level
• Support inspection readiness activities at site and country level.
• Collaborates in identifying patient, site or country level quality deficiencies which may lead to the creation quality events/issues, and support in discussions around those as required (i.e: CAPAs). This may include to conduct Site Oversight Visits triggered by observed quality signals
• Plan and conduct regular accompanied/assessment visits with CRAs
• Provides support to their CRAs in managing site issues, from a monitoring perspective, ensuring that monitoring activities are conducted according to expectations.
• May act as a site liaison with prime sites for Alexion to facilitate discussion and consultation around site compliance to ICH GCP and process improvements, as agreed with their line manager.
• Collaborates with in-country local roles (PMCO and DCQ) in monitoring quality oversight based on agreed KPIs. Maintain tools to document and track clinical monitoring activities as required.

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees