Alexion Pharmaceuticals, Inc. · 9 hours ago
Associate Director, Country Operations Management
Boston, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$136K/yr - $205K/yr
8+ years expAlexion Pharmaceuticals, Inc. is focused on creating life-changing medicines through innovative teamwork. The Associate Director, Country Operations Management will play a central role in implementing the country strategy and ensuring the successful delivery of operational trial activities across programs.
BiotechnologyHealth CareMedicalTherapeutics
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
Qualification
Required
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
Preferred
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
Benefits
Short-term incentive bonuses
Equity-based awards for salaried roles
Commissions for sales roles
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
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
bloomberglaw.com
2025-12-20
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