Clinical Country And Site Lead

Summary

Join Biogen as a Clinical Country and Site Lead in Poland, a remote role focused on providing local operational and scientific expertise to drive global clinical development strategy. You will be the primary contact for investigators, CRO staff, and global teams, ensuring high-quality clinical trials and strong relationships. Responsibilities include managing investigator relationships, overseeing CRO activities, and contributing to country-level strategic planning. This position requires extensive experience in clinical trial management, a science background, strong communication skills (fluent in Polish and English), and proven leadership abilities. Biogen offers a supportive and inclusive work environment with opportunities for growth and development.

Requirements

• Extensive (7 + years) experience of managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors
• Science background and education (B.A or B.S; advanced degree preferred)
• Deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling CCSL to discuss compound, development plans, and protocol endpoints with investigator site personnel
• Strong communication skills, including fluent Polish & English language
• Strong organizational skills and leadership skills, especially project management skills, with an ability to set clear goals, align priorities and lead multiple tasks/activities
• Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities
• Holder of work permit & residency in Poland

Responsibilities

• Maintain current awareness/information pertaining to local clinical knowledge of disease areas researched by Biogen, emerging standards of care, and trial related needs of clinicians in community.  Hold specific operational and scientific discussions and act as local QSDO expert for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy
• Coordinate cross functional local affiliate input as required to provide appropriate country level input into Clinical Development Plan
• Provide and manage investigator and site knowledge/relationships to highlight country level capabilities, interests, needs and satisfaction levels.  This would involve the development of a country level QSDO investigator engagement strategy, or execution of global strategy (in collaboration with WM or local medical) to position Biogen  as the company partner of choice for clinical trials
• Primary country level QSDO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities (e.g. SOV’s, audits, and inspection support)
• Act as Lead CCSL required. This includes but is not limited to membership in CDT and SMT(s), coordinating Program and Study Country Foundation, investigator assessment of (and feedback on) programs and protocols, and Site Selection activities. Also responsible for training CCSLs on therapeutic area and program, program and trial level communications, and ownership of CSO activities related to a given program or trial
• Primary country level QSDO/Biogen contact for all QSDO clinical studies, leading interactions or managing CCSA interactions to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO staff, and QSDO/global teams.  Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones
• Lead and manage required local activities as part of agreed country and site selection process to ensure appropriate input is sought from local treating physicians and other stakeholders. (e.g. investigator assessment of (and feedback on) programs and protocols)
• Provide operational direction for activities of assigned CCSA resources
• Support special projects or other QSDO activities as a representative of CSO or Country

Preferred Qualifications

Ideal candidate will be customer focused, with excellent leadership, interpersonal skills, cultural awareness, high emotional intelligence and collaborative decision making approach. Must build relationships throughout and across the organization whilst operating remotely

Benefits

Remote work model