国家与站点运营主管（CSO）
Associate Director, Country & Site Operations (CSO)
**职位简介**
高级经理，国家与现场运营（CSO）负责直接管理、发展和CSO团队成员的运营效率，包括临床国家与现场负责人（CCSL）、现场经理和现场可行性团队成员，这些成员支持百健在所有开发阶段和治疗领域的临床试验，具体根据业务和部门需求而定。该职位确保CCSL能够被适当部署、指导并配备资源，以提供高质量的国家和现场运营，包括国家情报、研究者和现场参与、发起方监督、问题升级以及跨职能协作。该职位促进在指定国家组合中的一致执行、检查准备、可持续的工作量管理和明确的责任分工。该职位与CSO领导、临床试验交付单元（CTDU）、临床监测负责人（CML）、现场经理、全球医学、附属团队、质量、人力资源及CRO/FSP合作伙伴密切合作。根据组合和组织需求，该职位也可能领导选定的国家、现场或CSO项目。
**工作职责**
- 主要利益相关方包括国家与现场运营（包括临床监测、现场可行性及患者招募）、CTDU、临床开发、全球医学、附属领导、质量、法规、人力资源、CRO/FSP合作伙伴、研究者和研究现场。
- 为指定的CCSL、SM和现场可行性团队成员（根据业务和部门需求）提供直接的直线管理，包括定期1对1沟通、目标设定、绩效评估、发展计划、辅导、认可，以及在人力资源和CSO领导的配合下及时处理绩效或行为问题。
- 通过结构化的入职培训、指导、反馈、发展任务和职业规划来建立CCSL、现场经理和现场可行性团队的能力和继任实力；培养责任感、协作、包容性、创新和持续学习。
- 根据业务优先级、能力、容量和发展需求，将CCSL分配到国家和研究组合中；监控工作量，并在出现风险或不平衡时建议调整资源配置或优先级。
- 监督CCSL交付的质量和一致性，包括国家和现场情报、研究者参与、国家和现场策略输入。
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**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
Job Level: Management
**Additional Information**
The base compensation range for this role is: $171,000.00-$235,500.00
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](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&data=05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&reserved=0) 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.