Associate Clinical Country and Site Lead – West Coast, Midwest

🔥 4 hours ago

🇺🇸 United States – Remote

💵 $116k - $155k / year

⏰ Full Time

🟠 Senior

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Support the Clinical Country and Site Lead in providing local operational and scientific knowledge to global teams • Integrate local opportunities and needs into clinical operational plans • Serve as country-level point of contact for CRO staff and QSDO/global teams • Enable delivery of local clinical trials with focus on quality, patient safety, and monitoring oversight • Escalate investigator concerns involving data integrity, patient safety, or unresolved CRO issues • Maintain awareness of local clinical knowledge, disease areas, standards of care, and clinician trial needs • Provide country-level therapeutic-area, disease-area, program, and study information to support global operational strategy • Coordinate local affiliate input into the Clinical Development Plan • Manage investigator and site knowledge and relationships • Develop or execute investigator engagement strategies • Lead or support local activities in country and site selection • Lead interactions for timely information flow and issue resolution across investigators, affiliate staff, CRO/FSP staff, and global teams • Analyze and monitor country performance KPIs and support country operational milestones • Support special projects and other QSDO activities as a CSO or Country representative

🎯 Requirements

• Bachelor’s degree or equivalent • 5+ years of clinical research experience, including managing clinical trial activities desirable, especially sponsor oversight in an outsourced/FSP model • Understanding of cross-functional drug development processes • High scientific/clinical knowledge across key therapeutic areas • Understanding of ICH/GCP, applicable country regulations, and clinical trial monitoring in an outsourced model • Strong organizational and project management skills • Ability to set clear goals, align priorities, and execute multiple tasks and activities • Effective working knowledge of relevant IT tools for virtual team working • Excellent knowledge of clinical operational activities and challenges across the local geography • Proven ability to handle high volumes of tasks with varying complexity and priorities • Strong communication skills • English language skill in countries where English is not the primary language • Ability to assimilate new knowledge rapidly • Willingness to travel up to 80% (1x/week) • Preferred: experience working in fully outsourced and Functional Service Provider (FSP) models

🏖️ Benefits

• Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation • Additional end-of-year shutdown time off (Dec 26-Dec 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 benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation • Short term and long-term incentives, including cash bonus and equity incentive opportunities