出海雷达

助理总监,国家与现场运营FSP监督经理

Associate Director, Country & Site Operations FSP Oversight Manager

职能支持限定地区(需当地身份)与中国几乎无重叠,需长期倒时差
公司Biogen
薪资$171,000 - $235,500/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求与中国几乎无重叠,需长期倒时差
用工类型permanent
发布时间17 天前
数据来源4dayweek.io
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。
作息提示:与中国几乎无重叠,需长期倒时差。

**关于该职位**

高级经理,国家及现场运营功能服务提供商(FSP)监督经理与CSO领导层及跨职能利益相关者合作,推动并管理CSO的FSP内部化模式。该职位负责监督和发展支持国家及现场临床试验执行的FSP员工,确保在各地区和治疗领域内嵌一致且高效的流程。该职位确保与CSO内部和外部利益相关者在FSP角色执行、绩效、质量和交付期望方面保持一致。该职位还作为CSO扩展领导模型的一部分,参与塑造CSO的运营战略和持续改进。

**您将负责**

- 管理最多20-25名分配在临床组合中的FSP员工,以支持CSO的国家和现场层面的运营目标。
- 领导资源预测、分配和优先级排序,以支持区域交付需求、组合需求和年度运营计划承诺。
- 支持FSP预算预测和财务监督,与CSO领导层合作优化资源利用和外部支出。
- 开发、完善并实施针对特定角色的流程、指导方针和质量期望,以在支持CSO活动的FSP员工中实现一致性。
- 与FSP供应商、CSO领导层和关键跨职能利益相关者合作,设计和实施培训和入职计划。
- 监督FSP资源的入职和离职,确保平稳过渡、角色清晰、政策合规以及国家和现场支持的连续性。
- 代表CSO参与FSP供应商治理、监督和绩效管理论坛。
- 监控、分析并报告适用的FSP角色绩效指标、质量指标、工作量趋势和交付风险。
- 与CSO区域领导、研究团队、医学、质量及其他利益相关者合作,对齐目标,加强以现场为中心的执行,并促进持续改进。
- 推动FSP运营模式的持续改进和演变,识别提升可扩展性、效率、角色清晰度、质量和成本效益的机会

**您具备**

您是一位经验丰富的临床运营领导者,具备国家/现场运营、资源管理和跨职能协作的专业知识,有推动临床试验执行和运营卓越的出色业绩。您在矩阵式环境中表现出色,擅长带领团队,具有出色的沟通和协调能力。您熟悉临床试验运营的各个方面,能够有效管理多任务和复杂项目。您注重细节,能够通过数据驱动决策,同时具备良好的战略思维和问题解决能力。

查看英文原文

**About This Role**

The Associate Director, Country & Site Operations Functional Service Provider (FSP) Oversight Manager partners with CSO leadership and cross-functional stakeholders to drive and manage CSO’s FSP insourcing model. This role oversees and develops FSP staff supporting country- and site-facing clinical trial execution, embedding consistent, efficient processes across regions and therapeutic areas. It ensures alignment with CSO’s internal and external

stakeholders on FSP role execution, performance, quality, and delivery expectations. This role also contributes to shaping CSO operational strategy and continuous improvement as part of the CSO extended leadership model.

**What You’ll Do**

- Manage up to 20-25 FSP staff assigned across the clinical portfolio to support CSO’s country and site-level operational objectives.
- Lead resource forecasting, assignment, and prioritization to support regional delivery needs, portfolio demand, and annual operating plan commitments.
- Support FSP budget forecasting and financial oversight, partnering with CSO leadership to optimize resource utilization and external spend.
- Develop, refine, and implement role-specific processes, guidance, and quality expectations to drive consistency across FSP staff supporting CSO activities.
- Design and implement training and onboarding programs in collaboration with FSP vendors, CSO leaders, and key cross-functional stakeholders.
- Oversee onboarding and offboarding of FSP resources, ensuring smooth transitions, role clarity, policy compliance, and continuity of country and site support.
- Represent CSO in FSP vendor governance, oversight, and performance management forums.
- Monitor, analyze, and report applicable FSP role performance metrics, quality indicators, workload trends, and delivery risks.
- Partner with CSO regional leaders, study teams, Medical, Quality, and other stakeholders to align on goals, strengthen site-centric execution, and promote continuous improvement.
- Drive continuous improvement and evolution of the FSP operating model, identifying opportunities to improve scalability, efficiency, role clarity, quality, and cost effectiveness

**Who You Are**

You are an experienced clinical operations leader with expertise in country/site operations, resource management, and cross-functional collaboration, with a strong track record of driving clinical trial execution and operational excellence. You thrive in matrixed environments, excel at leading teams and vendor partnerships, and are passionate about building scalable processes that improve quality, efficiency, and delivery.

**Required Skills**

- Bachelors degree in a scientific discipline; advanced degree preferred.
- 8+ years of clinical research, clinical operations, country/site operations, or project management experience, preferably with both a sponsor company and/or FSP vendor supporting insourced clinical trial delivery.
- Experience managing resources, vendors, and cross-functional stakeholders is required; line management experience is advantageous.
- Proven ability to manage and oversee FSP staff, including resource planning, training, performance management, and workload prioritization.
- Ability to leverage strong knowledge of country and site operations, clinical trial execution, and key business drivers to maximize FSP staff performance.
- Strong cross-functional knowledge of drug development and expertise in clinical trial phases I–IV, including country activation, site engagement, study conduct, and inspection readiness.
- Effective line management and mentoring skills, with the ability to build strong relationships across all organizational levels and geographies.
- Excellent leadership, communication, and organizational skills, with strengths in problem solving, conflict resolution, stakeholder management, and team building. In-depth knowledge of GCP, ICH guidelines, regulatory requirements, and quality expectations for global clinical development.
- Strong project management capabilities, including risk assessment, contingency planning, vendor oversight, and issue escalation within an insourced FSP model.
- Collaborative, site-centric mindset with the ability to partner effectively with internal and external stakeholders to drive consistent delivery and continuous improvement.

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.

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