Associate Clinical Country and Site Lead (West Coast/Midwest)

About the Role

The Associate Clinical Country and Site Lead (aCCSL) supports the Clinical Country and Site Lead (CCSL) by providing global teams with detailed local operational and scientific knowledge to inform the overall clinical development strategy. This role ensures local opportunities and needs are integrated into operational plans. At the country level, the aCCSL serves as a single point of contact for CRO staff and QSDO/global teams, focusing on quality, patient safety, and oversight of monitoring activities and performance.

The aCCSL also acts as a site escalation point for investigator concerns related to data integrity, patient safety, or unresolved issues, ensuring these are communicated to the appropriate Biogen parties. As assigned, the aCCSL may interact with FSP resources and support monitoring operations.

Responsibilities

• Maintain current awareness of local clinical knowledge of disease areas researched by Biogen, emerging standards of care, and trial-related needs of clinicians.
• Act as the local Quantitative Sciences & Development Operations (QSDO) expert, providing country-level therapeutic area, disease area, and program/study information to drive and support global operational strategy.
• Coordinate cross-functional local affiliate input to provide country-level insights into the Clinical Development Plan.
• Manage investigator and site relationships to highlight country-level capabilities, interests, needs, and satisfaction levels, including developing or executing a country-level QSDO investigator engagement strategy.
• Lead and/or support local activities as part of the country and site selection process, ensuring input from local treating physicians and stakeholders (e.g., investigator feedback on programs and protocols).
• Serve as the primary country-level QSDO/Biogen contact for all QSDO clinical studies, ensuring timely local information flow and resolution of issues with investigators, affiliate staff, CRO/FSP staff, and QSDO/global teams.
• Analyze and monitor overall Country Performance (KPIs) and support country-focused activities to deliver operational milestones.
• Support special projects or other QSDO activities as a representative of CSO or the country.

Qualifications

• Bachelor’s degree or equivalent.
• 5+ years of clinical research experience, including managing clinical trial activities, with a focus on sponsor oversight in an outsourced/FSP model.
• Understanding of the cross-functional drug development process and high scientific/clinical knowledge across key therapeutic areas.
• Familiarity with ICH/GCP, applicable country regulations, and clinical trial monitoring in an outsourced model.

Skills

• Strong organizational and project management skills, with the ability to set clear goals, align priorities, and execute multiple tasks.
• Effective working knowledge of relevant IT tools to promote virtual team collaboration.
• Excellent understanding of clinical operational activities and challenges within the local geography.
• Proven ability to handle a high volume of tasks of varying complexity within given timeframes and priorities.
• Strong communication skills, including proficiency in English for countries where it is not the primary language.
• Ability to rapidly assimilate new knowledge.
• Willingness to travel up to 80% (1x/week).

Preferred Skills

• Experience working in fully outsourced and Functional Service Provider (FSP) models.

Pay

The base compensation range for this role is $116,000.00 - $155,000.00. Base salary is determined through an analytical approach considering skills, experience, job location, and internal equity. Regular employees are eligible for short-term and long-term incentives, including cash bonuses and equity opportunities based on individual, business unit, and company performance.

Benefits

• Medical, dental, vision, and life insurance.
• Fitness and wellness programs, including a fitness reimbursement.
• Short- and long-term disability insurance.
• A minimum of 15 days of paid vacation plus an end-of-year shutdown (December 26-31).
• 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.
• 401(k) program with company-matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Participation in Employee Resource Groups.

Schedule

This is a field-based, country-aligned role targeting the West Coast or Midwest Region. Willingness to travel up to 80% (1x/week) is required.