In this strategically focused role of Clinical Country Site Lead, you will drive global clinical development strategies by providing essential local operational and scientific expertise. As part of a regionally aligned team, your contributions will be pivotal in enhancing global customer satisfaction and supporting the delivery and execution of Biogen's development pipeline. You will manage the integration of local opportunities into global strategies and ensure operational plans reflect country-specific needs. Serving as the primary contact for Investigators, affiliate office staff, CRO staff, and global teams, your role is crucial in delivering local clinical trials with a focus on quality, patient safety, and effective oversight. The Clinical Country Site Lead is a key player in ensuring that investigator concerns are promptly addressed, safeguarding data integrity and patient safety, while contributing to the overall success of Biogen's clinical research endeavors.
This job posting is for an existing vacancy in the organization
What You'll Do:- Maintain up-to-date local knowledge of therapeutic areas researched by Biogen, standards of care, and clinical trial requirements.
- Engage in operational and scientific discussions as the local QSDO representative to offer country-level insights on therapeutic areas related to studies and programs.
- Support and drive global operational strategy by providing study information.
- Highlight country-level capabilities and needs through investigator and site knowledge.
- Manage relationships with investigators and sites to foster collaboration and satisfaction.
- Position Biogen as the preferred partner for clinical trials through strong investigator partnerships.
- Lead local activities in the country and site selection process, ensuring stakeholder input.
- Act as the primary country-level contact for strategic development and execution of sponsor oversight of CRO activities.
- Oversee compliance with ICH/GCP, local regulations, and sponsor requirements through Sponsor Oversight Visits and audit support.
- Serve as the primary contact for all QSDO clinical studies, ensuring issue resolution and timely information flow.
- Monitor and analyze trial and country progress to support QSDO deliverables and country goals.
- Address local trial challenges and ensure effective communication and alignment with global teams.
- Act as Lead CCSL for study or program leadership as required, coordinating various activities.
- Train aCCSLs/CCSLs on therapeutic areas, program communications, and CSO activities.
- Perform company business in compliance with regulations, policies, and procedures.
Who You Are: You are a proactive and detail-oriented individual who thrives in a dynamic and collaborative environment. Your strong communication skills and ability to rapidly assimilate new knowledge position you as a trusted partner in clinical research. You are customer-focused, with a high level of emotional intelligence and cultural awareness, allowing you to build meaningful relationships across the organization, even when operating remotely. Your leadership skills are complemented by a collaborative decision-making approach, making you an asset to global and local teams alike.
Required Skills:- University degree with a science background or equivalent education and experience; advanced degree preferred.
- Minimum 8 years of clinical research experience, with an emphasis on managing clinical trial activities and sponsor oversight.
- Strong communication skills, including proficiency in English in non-English speaking countries.
- Understanding of the cross-functional drug development process and scientific knowledge across key therapeutic areas.
- Knowledge of ICH/GCP, country regulations, and clinical trial monitoring in an outsourced model.
- Strong organizational and project management skills.
- Effective working knowledge of IT tools for virtual teamwork.
- Excellent knowledge of clinical operational activities across local geography.
- Ability to handle high volumes of tasks with varying complexity and priorities.
- Proficiency in working across multiple digital platforms and early adoption of new systems/applications.
Preferred Skills:- Experience in managing sponsor oversight activities in an outsourced/FSP model with CROs/vendors.
- Proven ability to build relationships throughout and across the organization while operating remotely.
- Willingness to travel 20% - 25%.
The expected salary range for this position is $127,000 to $169,750 and includes eligibility for a discretionary bonus.
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 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.
Job Level: Management
