Associate Clinical Country Lead

About the role

This position is an externally facing, country-aligned clinical operations role. It is responsible for bringing local operational and scientific insight into country-level clinical development planning and execution. The role supports local collaboration, improves stakeholder experience, and helps drive delivery of Biogen’s development pipeline.

You will partner closely with the Director, Clinical Country & Site Lead, and the in-country Clinical Country & Site Lead or Senior Clinical Country & Site Lead. Together, you will equip study teams with country-specific operational and scientific input that strengthens clinical trial delivery. A key part of the role is ensuring that local needs, opportunities, and insights are reflected in operational plans.

You will be the main point of contact for investigators, affiliate office colleagues, CRO teams, and QSDO/global stakeholders. The role supports successful local trial execution with a strong emphasis on quality, patient safety, and oversight of CRO performance and activities. You will also escalate site-level concerns to the appropriate Biogen contact when issues involve data integrity, data quality, patient safety, or matters not resolved by the CRO.

Key responsibilities

• Stay current on Biogen’s local therapeutic areas, standards of care, trial requirements, and the priorities of investigators and research sites.
• Develop and sustain effective relationships with investigators and sites so Biogen is viewed as a preferred research partner.
• Support country and site selection by collecting field insights and feedback from investigators and other stakeholders.
• Serve as the country-level QSDO/Biogen contact for sponsor oversight work, including Sponsor Oversight Visits, inspections, audits, and CRO oversight.
• Carry out co-monitoring during Sponsor Oversight Visits and confirm that study records, informed consent files, and source documents comply with the protocol, ICH-GCP, SOPs, and local rules.
• Coordinate discussions with investigators, affiliate teams, CRO personnel, and global partners to keep information moving and resolve issues quickly.
• Track and evaluate trial and country performance against QSDO goals and local objectives.
• Contribute to local initiatives and broader Clinical Study Operations work as the country representative.

Candidate profile

The ideal candidate is a cooperative and flexible clinical research professional who performs well in a matrixed setting. This person should bring strong relationship-building ability, good judgment, and a practical, solution-oriented mindset. Comfort with ambiguity, the ability to juggle several priorities, and a consistent focus on quality, patient safety, and stakeholder experience are important. A genuine interest in clinical research and in helping deliver innovative medicines to patients is essential.

Requirements

• A university degree, or an equivalent background with a science focus and relevant experience.
• At least 5 years of experience in clinical research.
• Experience with clinical trial operations is preferred, especially sponsor oversight work in an outsourced or FSP model with CROs and vendors.
• Solid understanding of the cross-functional drug development process and strong clinical/scientific knowledge across key therapeutic areas.
• Ability to discuss compounds, development plans, and protocol endpoints with investigator site staff.
• Knowledge of ICH-GCP, applicable country regulations, and clinical trial monitoring in an outsourced model.
• Strong planning and project management skills, including setting goals, aligning priorities, and delivering multiple tasks on time.
• Working knowledge of relevant IT tools for virtual teamwork.
• Good understanding of clinical operations challenges in the local geography.
• Customer-oriented mindset with strong interpersonal skills, cultural sensitivity, emotional intelligence, and a collaborative decision-making style.
• Ability to build relationships across the organization while working remotely.
• Proven ability to manage a large number of tasks of varying complexity within tight timeframes and shifting priorities.
• Strong communication skills, including English in countries where it is not the primary language.
• Ability to absorb new information quickly.

Why Biogen

Biogen describes itself as a global team committed to excellence and guided by a pioneering spirit. As a mid-sized biotechnology company, it offers the stability and resources of an established business along with the chance for individual contributions to have real impact. The environment is designed to support learning, growth, and skill development while working together to deliver medicines that can change lives.

Inclusion and equal opportunity

Biogen states that it is committed to building a culture of inclusion and belonging that reflects the communities it serves. The company values diverse backgrounds, cultures, and perspectives as a source of strength and innovation. All qualified applicants are to be considered for employment without discrimination based on 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 legally protected status. Biogen is also an E-Verify employer in the United States.

Additional information

Job level: Management.