Associate Director, Country & Site Operations

atBiogenRemoteUS flagUnited StatesFull-timeOperationsSenior$171k – $235.5k/year

Posted 3 days ago

This is a fully remote position, open to applicants in United States.

📋 Description

• Directly manage assigned Clinical Country & Site Leads, Site Managers, and members of the Site Feasibility team.

• Facilitate regular one-on-one meetings, set objectives, conduct performance reviews, create development plans, provide coaching, recognize achievements, and manage performance or conduct issues.

• Enhance team capability and succession strength through onboarding, mentoring, constructive feedback, development assignments, and career planning.

• Distribute Clinical Country & Site Leads (CCSLs) across country and study portfolios according to business priorities, capabilities, capacity, and developmental needs.

• Monitor workloads and recommend changes in resourcing or prioritization when risks or imbalances are identified.

• Ensure the quality and consistency of country and site intelligence, engage with investigators, contribute to country and site strategy input, manage Sponsor Oversight Visits, oversee CRO/FSP activities, escalate issues, and support audits or inspections.

• Provide operational insights and recommendations for protocol planning, country and site selection, enrollment expectations, and study execution.

• Act as an escalation and decision-support resource for concerns related to country, site, investigator, data integrity, patient safety, quality, and partner performance.

• Collaborate with Clinical Management Leads (CMLs), Site Managers, study teams, affiliates, CROs, and FSP organizations to clarify roles and overcome delivery challenges.

• Monitor team objectives, operational performance, capability requirements, and portfolio risks.

• Offer updates and recommendations to CSO leadership while assisting in workforce, resource, and budget planning.

• Lead or contribute to initiatives related to the CSO operating model, process improvements, and change management.

• Represent CSO in designated cross-functional forums.


⛳️ Requirements

• A Bachelor's Degree is required; an advanced degree is preferred.

• A minimum of 8 years of experience in clinical research, clinical development, or clinical operations, including significant experience in country-facing or site-facing operational roles.

• Proven experience in managing clinical trial activities and sponsor oversight within outsourced, CRO, FSP, or hybrid delivery models.

• Experience in leading teams or matrix organizations, encompassing coaching, talent development, performance management, workload planning, and oversight of delivery.

• Familiarity in partnering with global study teams, affiliates, Medical, Development, Quality, monitoring teams, site feasibility teams, and external collaborators.

• Strong judgment, problem-solving abilities, communication skills, stakeholder management, and the capacity to influence in a complex matrix environment.

• Proficient use of relevant digital tools to support virtual teams, enhance performance visibility, resource planning, and operational oversight.

• Ability to evaluate capability and workload, prioritize tasks, allocate resources, and uphold accountability across multiple countries, studies, and stakeholders.

• Competence in managing sensitive personnel matters with discretion and effectively collaborating with Human Resources and leadership.

• Preferred experience with site feasibility.

• Travel (approximately 10%) may be necessary based on business and site requirements.

• Must be legally authorized to work in the United States, as affirmed by the U.S. E-Verify employer statement.


🏝️ Benefits

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Comprehensive Medical, Dental, Vision, & Life insurance options.

• Access to Fitness & Wellness programs, including fitness reimbursement.

• Short- and Long-Term Disability insurance coverage.

• A minimum of 15 days of paid vacation.

• Additional time off for an end-of-year shutdown (December 26-31).

• Up to 12 company-paid holidays.

• 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Opportunities for participation in Employee Resource Groups.

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