Clinical Country Site Lead (Southwest)
Biogen
August 07, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Responsibilities:
- Support and manage the internalized flexible model, collaborating with Clinical Monitoring Leads (CMLs), CRAs, and FSP partners; support partners under the FSO model.
- Maintain up-to-date local therapeutic area and clinical trial requirements knowledge.
- Provide country-level information through operational and scientific discussions.
- Drive global operational strategy by delivering study information.
- Manage investigator and site relationships.
- Lead local country and site selection activities incorporating stakeholder feedback.
- Serve as primary contact for sponsor oversight of CRO activities.
- Oversee Sponsor Oversight Visits, audits, and inspections to ensure regulatory compliance.
- Monitor trial progress, address local challenges, and align with global teams.
- Act as Lead CCSL for study/program leadership, including training and coordination of site selection.
- Build relationships across the organization while operating remotely.
Qualifications / Required skills:
- Bachelor’s degree in a science background (advanced/graduate degree preferred).
- 8+ years clinical research experience, including managing clinical trial activities and sponsor oversight with CROs/vendors.
- Understanding of cross-functional drug development and clinical/scientific knowledge across key therapeutic areas.
- Familiarity with ICH/GCP and country regulations.
- Strong organizational/project management skills.
- Proficiency with IT tools for virtual teamwork.
- Excellent knowledge of clinical operational activities in local geography.
- Strong communication skills (English proficiency).
- Travel 50–75% (2–3x/month).
Preferred skills:
- Leadership and interpersonal skills; collaborative decision-making.
- High emotional intelligence and cultural awareness.
Benefits (as listed):
- Medical, dental, vision, and life insurance; fitness/wellness reimbursement; short- and long-term disability; paid vacation (15+ days) and end-of-year shutdown; company holidays; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.
- Support and manage the internalized flexible model, collaborating with Clinical Monitoring Leads (CMLs), CRAs, and FSP partners; support partners under the FSO model.
- Maintain up-to-date local therapeutic area and clinical trial requirements knowledge.
- Provide country-level information through operational and scientific discussions.
- Drive global operational strategy by delivering study information.
- Manage investigator and site relationships.
- Lead local country and site selection activities incorporating stakeholder feedback.
- Serve as primary contact for sponsor oversight of CRO activities.
- Oversee Sponsor Oversight Visits, audits, and inspections to ensure regulatory compliance.
- Monitor trial progress, address local challenges, and align with global teams.
- Act as Lead CCSL for study/program leadership, including training and coordination of site selection.
- Build relationships across the organization while operating remotely.
Qualifications / Required skills:
- Bachelor’s degree in a science background (advanced/graduate degree preferred).
- 8+ years clinical research experience, including managing clinical trial activities and sponsor oversight with CROs/vendors.
- Understanding of cross-functional drug development and clinical/scientific knowledge across key therapeutic areas.
- Familiarity with ICH/GCP and country regulations.
- Strong organizational/project management skills.
- Proficiency with IT tools for virtual teamwork.
- Excellent knowledge of clinical operational activities in local geography.
- Strong communication skills (English proficiency).
- Travel 50–75% (2–3x/month).
Preferred skills:
- Leadership and interpersonal skills; collaborative decision-making.
- High emotional intelligence and cultural awareness.
Benefits (as listed):
- Medical, dental, vision, and life insurance; fitness/wellness reimbursement; short- and long-term disability; paid vacation (15+ days) and end-of-year shutdown; company holidays; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.