Clinical and Site Lead

Clinical Country and Site Lead (CCSL)

As a Clinical Country and Site Lead (CCSL), you will play a pivotal role in advancing global clinical development strategies by harnessing key local operational and scientific knowledge. Your strategic focus will be on fostering local partnerships to enhance global customer satisfaction and support the execution of our development pipeline. This role will provide global teams with in-depth local insights, ensuring that regional opportunities and needs are integrated into operational plans.

At the country level, you will direct operational priorities and manage resources effectively, serving as the primary point of contact for investigators, affiliate office staff, CRO staff, and global teams. Your expertise will ensure the successful delivery of local clinical trials while maintaining a focus on quality and patient safety. Additionally, you'll address investigator concerns and collaborate with internal teams to support innovative working methods.

• Maintain up-to-date knowledge of therapeutic areas and clinical trial requirements relevant to Biogen.
• Engage in discussions to provide country‑level information on therapeutic areas related to studies and programs.
• Provide study information to support and drive global operational strategy.
• Manage investigator and site relationships to foster collaboration and high satisfaction.
• Lead local activities for country and site selection, ensuring input from local stakeholders.
• Act as the primary country‑level contact for strategic development and execution of sponsor oversight activities.
• Oversee compliance with ICH/GCP and local regulations during Sponsor Oversight Visits and audits.
• Serve as the main contact for all QSDO clinical studies, ensuring timely resolution of issues.
• Monitor and analyze trial progress to support deliverables and goals.
• Act as Lead CCSL when required, coordinating program and trial activities.
• Support and manage the internalized flexible model, collaborating with Clinical Monitoring Leads and CRAs.
• Partner with Clinical Monitoring Leads and Site Managers to ensure clear communication with FSPs and effective country‑level operations, while supporting fully outsourced teams.

You are a strategic thinker with a deep understanding of clinical research and the ability to integrate scientific insights into operational strategies. Your strong interpersonal skills and cultural awareness enable you to build effective relationships across diverse teams. You are a problem‑solver, capable of addressing challenges proactively and aligning priorities to achieve goals. Your high emotional intelligence and customer‑focused approach drive collaboration and decision‑making, while your organizational skills ensure the successful management of complex projects.

• Minimum 8 years of clinical research experience.
• Experience managing clinical trial activities, particularly in an outsourced model with CROs.
• Strong understanding of cross‑functional drug development and scientific knowledge across therapeutic areas.
• Familiarity with ICH/GCP guidelines and applicable country regulations.
• Strong project management and organizational skills.
• Effective knowledge of IT tools for virtual teamwork.
• Excellent communication skills, including proficiency in English.
• Ability to handle a high volume of tasks and assimilate new knowledge rapidly.
• University degree with a scientific background; advanced degree preferred.

• Leadership skills and experience in a collaborative decision‑making environment.
• Proven ability to build and maintain relationships across the organization.
• Experience in handling sponsor oversight activities in a flexible service provider model.
• Willingness to travel 20%-25%.

Salary range: $127,000 to $169,750. Includes eligibility for a discretionary bonus. Base salary determined by an analytical approach based on skills, experience, location, and internal equity. Regular employees are eligible for short‑term and long‑term incentives, including cash bonus and equity incentive opportunities.

Benefits include health care, retirement, paid time off, and ancillary programs such as a fully paid sabbatical after six years of service, Employee Stock Purchase Plan participation, education assistance, and more.

Management

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.