Clinical Country Site Lead

Role Summary

Clinical Country Site Lead (CCSL) is a field-based, country-aligned role providing local operational and scientific expertise to drive global clinical development strategy, enable local partnerships, and support country-focused delivery and execution of the R&D pipeline.

Responsibilities

• Maintain current awareness of local clinical knowledge, emerging standards of care, and trial needs of clinicians; act as local QSDO expert to drive and support global operational strategy; coordinate cross-functional local input for Clinical Development Plan.
• Develop and manage investigator and site knowledge/relationships to highlight country-level capabilities, needs, and satisfaction; implement a country-level QSDO investigator engagement strategy.
• Serve as primary country-level QSDO/Biogen contact for sponsor oversight of clinical trial monitoring activities; may interact with FSP resources and support monitoring operations.
• Act as Lead CCSL as required, including membership in CDT/ SMTs, coordinating program and study country foundations, site selection activities, and training CCSLs on therapeutic areas and program communications.
• Lead interactions to ensure timely local information flow and resolution of issues with investigators, affiliate staff, CRO/FSP staff, and global teams; monitor Country Performance KPIs and support country milestones.
• Lead local activities in country/site selection processes to gather input from treating physicians and stakeholders.
• Provide operational direction for assigned associate CCSLs as needed; support special projects or other QSDO activities as a CSO/Country representative.

Qualifications

• Required: B.A. or B.S. degree in a scientific discipline; minimum 8 years in clinical research; experience managing clinical trial activities, preferably sponsor oversight in outsourced/FSP models; strong knowledge of cross-functional drug development and ICH/GCP with regulatory familiarity; excellent project management and organizational skills; proficiency with IT tools for virtual teamwork; strong knowledge of clinical operations across local geography; customer-focused with leadership, interpersonal, and cross-cultural abilities; ability to manage multiple tasks and priorities; strong English communication skills.
• Preferred: Advanced degree; experience in fully outsourced/FSP models.

Skills

• Strong site management and relationship-building skills
• Strategic thinking with ability to influence global operational plans
• Excellent communication and collaboration across cross-functional teams
• Ability to work remotely and build relationships across the organization

Education

• B.A. or B.S. in a scientific discipline (required); advanced degree preferred.

Additional Requirements

• Location and travel: Field-based role with country-focused responsibilities (travel as required for site oversight and collaboration).
• Other: None specified.