Associate Director, Country & Site Operations (CSO)

About This Role

The Associate Director, Country & Site Operations (CSO) is accountable for the direct line management, development, and operational effectiveness of CSO team members, including Clinical Country & Site Leads (CCSLs), Site Managers, and Site Feasibility team members supporting Biogen clinical trials across all phases of development and therapeutic areas, as based on business and department needs This role ensures CCSLs are appropriately deployed, coached, and equipped to deliver high-quality country and site operations, including country intelligence, investigator and site engagement, sponsor oversight, issue escalation, and cross-functional collaboration. The position promotes consistent execution, inspection readiness, sustainable workload management, and clear accountability across assigned country portfolios. The role partners closely with CSO leadership, Clinical Trial Delivery Units (CTDU), Clinical Monitoring Leads (CMLs), Site Managers, Worldwide Medical, affiliate teams, Quality, Human Resources, and

CRO/FSP partners. The position may also lead selected country, site, or CSO initiatives based on portfolio and organizational needs.

What You’ll Do

• Key stakeholders include Country & Site Operations (including Clinical Monitoring, Site Feasibility and Patient Recruitment), CTDU, Clinical Development, Worldwide Medical, Affiliate Leadership, Quality, Regulatory, Human Resources, CRO/FSP partners, investigators, and research sites.
• Provide direct line management for assigned CCSLs, SMs, and Site Feasibility team members (as based on business and department needs), including regular 1:1s, objective setting, performance reviews, development planning, coaching, recognition, and timely management of performance or conduct concerns in partnership with Human Resources and CSO leadership.
• Build CCSL, Site Manager, and Site Feasibility team capability and succession strength through structured onboarding, mentoring, feedback, development assignments, and career planning; foster accountability, collaboration, inclusion, innovation, and continuous learning.
• Allocate CCSLs across country and study portfolios based on business priorities, capability, capacity, and development needs; monitor workload and recommend resourcing or prioritization changes when risks or imbalances arise.
• Oversee the quality and consistency of CCSL delivery, including country and site intelligence, investigator engagement, country and site strategy input, Sponsor Oversight Visits, CRO/FSP oversight, issue escalation, and audit or inspection support.
• Guide CCSLs in translating local operational, scientific, healthcare, competitive, and regulatory insights into practical recommendations for protocol planning, country and site selection, enrollment assumptions, and study execution.
• Serve as an escalation and decision-support point for CCSLs on country, site, investigator, data integrity, patient safety, quality, or partner-performance concerns; ensure issues are routed promptly to the appropriate accountable stakeholders.
• Partner with CMLs, Site Managers, study teams, affiliates, CROs, and FSP organizations to clarify roles, strengthen sponsor oversight, resolve delivery barriers, and maintain consistent execution standards.
• Track team objectives, operational performance, capability needs, and portfolio risks; provide concise updates and recommendations to CSO leadership and support workforce, resource, and budget planning as assigned.
• Lead or contribute to CSO operating-model, process-improvement, and change initiatives, and represent CSO in selected cross-functional forums.
• Travel (~10%) may be required based on business and site needs.

Who You Are

You are a collaborative and influential leader with deep expertise in global clinical development and global clinical trial operations. You understand how country and site strategies, operational execution, regulatory compliance, patient safety, and quality oversight come together to accelerate the delivery of innovative therapies to patients.

You lead through empowerment, developing talent, building organizational capability, and creating a culture of accountability and continuous improvement. You are skilled at navigating complex stakeholder environments, managing outsourced delivery models, and translating operational insights into strategic decisions.

You embrace innovation, leveraging digital tools and data-driven approaches to improve planning, resource management, performance visibility, and trial execution. Above all, you are driven by a commitment to operational excellence, patient impact, and helping teams achieve their full potential.

Required Skills

• Bachelor's Degree required; advanced degree preferred.
• 8+ years of experience in clinical research, clinical development, or clinical operations, including substantial country-facing or site-facing operational experience.
• Experience managing clinical trial activities and sponsor oversight in outsourced, CRO, FSP, or hybrid delivery models is required.
• Demonstrated experience leading people and/or matrix teams, including coaching, talent development, performance management, workload planning, and delivery oversight, is required.
• Experience partnering with global study teams, affiliates, Medical, Development, Quality, monitoring teams, site feasibility teams, and external partners is expected.
• Strong judgment, problem-solving, communication, stakeholder management, and influencing skills in a complex matrix environment.
• Effective use of relevant digital tools to support virtual teams, performance visibility, resource planning, and operational oversight.
• Ability to assess capability and workload, set priorities, allocate resources, and maintain accountability across multiple countries, studies, and stakeholders.
• Ability to manage sensitive people matters with discretion and partner effectively with Human Resources and leadership.

Preferred Skills

• Experience with site feasibility

Additional Information

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. 

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement 
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance 
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit 
• 401(k) program participation with company matched contributions
• Employee stock purchase plan 
• Tuition reimbursement of up to $10,000 per calendar year 
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.