United States · Remote OK
$116k–$155k/yr
About This Role The Associate Clinical Country and Site Lead (aCCSL) role will support the Clinical Country and Site Lead (CCSL) in providing global teams with detailed local operational and scientific knowledge to infor…
Skills: Clinical research, Site management, Project management, Stakeholder management, Clinical trial oversight
Cambridge, Massachusetts, United States · On-site
$111k–$144k/yr
About This Role: We are seeking a highly motivated Scientist to join our dynamic neuromuscular research group and advance research programs focused on neuromuscular disorders. The ideal candidate will leverage expertise …
Skills: Muscle biology, Physiology, Translational research, iPSC-derived culture, Cardiomyocyte culture
Cambridge, Massachusetts, United States · Hybrid
$222k–$305k/yr
About This Role: As the Head of Digital Transformation Patient Services, you will be at the forefront of evolving Biogen's Patient Support Services (PSS) team. Your strategic leadership will guide large-scale initiatives…
Skills: Digital transformation, Patient support services, Strategic leadership, Customer experience, Project management
Detroit, Michigan, United States · Remote OK
$184k–$253k/yr
About this role: The Multiple Sclerosis (MS) Key Customer Manager (KCM) will have 3 primary strategic imperatives for Biogen, (1) Shaping the MS Treatment Dialogue, (2) Improving the customer experience with Biogen, and …
Skills: Account management, Pharmaceutical industry knowledge, Biotech industry knowledge, Multiple sclerosis disease state knowledge, Health care reimbursement
New York, New York, United States · Remote OK
$184k–$253k/yr
About this role: The Multiple Sclerosis (MS) Key Customer Manager (KCM) will have 3 primary strategic imperatives for Biogen, (1) Shaping the MS Treatment Dialogue, (2) Improving the customer experience with Biogen, and …
Skills: Account management, Pharmaceutical sales, Biotech experience, Multiple sclerosis disease state knowledge, Strategic engagement
Cambridge, Massachusetts, United States · Hybrid
$164k–$226k/yr
About This Role This Associate Director Neuropsychiatry HCP Marketing is responsible for establishing strategic direction of HCP engagement for our neuropsychiatry franchise, with a focus on postpartum depression. More s…
Skills: HCP marketing, Strategic planning, Neuropsychiatry, Product marketing, Commercial experience
Research Triangle Park, North Carolina, United States · On-site
$98k–$127k/yr
About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on days (6:0…
Skills: Manufacturing supervision, cGMP compliance, Drug substance manufacturing, Team leadership, Staff development
Cambridge, Massachusetts, United States · Hybrid
$183k–$252k/yr
About the Role The Global Associate Medical Director, Evidence Generation and Education is a key member of the Global Medical Rare Disease team, reporting into the Rare Disease Global Medical Lead and supporting the Glob…
Skills: Evidence generation, Medical affairs, Rare disease, Registry-based research, Real-world data
Cambridge, Massachusetts, United States · Hybrid
$209k–$288k/yr
The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quant…
Skills: Clinical operations, Program leadership, Clinical development, Strategic planning, Risk management
Cambridge, Massachusetts, United States · Hybrid
$225k–$310k/yr
About This Role The Global Medical Director, Rare Disease (SMA) Medical Education role is part of Rare Disease (SMA/ALS) Global Medical team, a strategic partner within Biogen that helps inform medical practice across ou…
Skills: Medical education strategy, Rare disease expertise, Spinal muscular atrophy, Biomarker strategy, Evidence generation
Cambridge, Massachusetts, United States · Hybrid
$225k–$310k/yr
About the Role The Global Medical Director, Rare Disease Evidence Generation – ALS and SMA is a key member of the Global Medical Rare Disease team, responsible for leading all evidence generation efforts — including regi…
Skills: Evidence generation, Rare disease research, Registry-based studies, Real-world data analysis, Medical strategy
Cambridge, Massachusetts, United States · Hybrid
$234k–$322k/yr
About This Role The Senior Director, External Growth & Innovation will drive commercial innovations that create value for our business, patient communities and customers. This key leader will conceptualize, develop, gain…
Skills: Commercial strategy, Innovation strategy, AI-enabled solutions, Process redesign, Cross-functional leadership
Cambridge, Massachusetts, United States · Hybrid
$241k–$332k/yr
About This Role: As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in B…
Skills: Regulatory strategy, Biologics, Advanced therapy medicinal products, CMC regulatory, Leadership
Research Triangle Park, North Carolina, United States · On-site
$23/hr–$30/hr
About this role Our factories run 24/7 operations. Our maintenance team currently works 10-hour shifts (either Days or Nights) Shift Details: Alternating schedule, Monday–Thursday one week; Tuesday–Friday the following w…
Skills: Troubleshooting, Preventative maintenance, Corrective maintenance, Mechanical systems, Electrical systems
Research Triangle Park, North Carolina, United States · Hybrid
$81k–$105k/yr
About This Role We are seeking a skilled Sr. Program Lead to implement regulatory, legal, and commercial compliance controls for identified areas of promotional risk. This position is responsible for working cross-functi…
Skills: Technical writing, Process optimization, Regulatory compliance, Knowledge management, Cross-functional collaboration
Research Triangle Park, North Carolina, United States · On-site
$25/hr–$34/hr
About this role Our factories run 24/7 operations. Our maintenance team currently works 10-hour shifts (either Days or Nights) Shift Details: Alternating schedule, Monday–Thursday one week; Tuesday–Friday the following w…
Skills: Preventative maintenance, Corrective maintenance, Troubleshooting, Mechanical systems, Electrical systems
Research Triangle Park, North Carolina, United States · Hybrid
$54k–$71k/yr
About This Role: As a Senior Case Manager in Patient Services, you will join a dynamic team dedicated to facilitating access to our treatments by overcoming non-clinical challenges and ensuring compliance with regulatory…
Skills: Case management, Patient services, Reimbursement processes, Benefit investigations, Prior authorization
Madrid, Community of Madrid, Spain · Hybrid
The incumbent will work closely with the medical team to align on strategic priorities at local and regional level in order to: provides medical / scientific expertise ensuring understanding of the disease area and Bioge…
Skills: Medical affairs, Project management, Scientific communication, Data analysis, Vendor management
Research Triangle Park, North Carolina, United States · Hybrid
$62k–$81k/yr
About This Role As a Buyer at Biogen, you will play a crucial role in our cross-functional team, ensuring that GMP/raw materials are procured efficiently and in compliance with established policies, strategies, and proce…
Skills: Procurement, Purchasing, GMP compliance, Inventory planning, Supply chain management
Research Triangle Park, North Carolina, United States · On-site
$23/hr–$30/hr
About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on days (6:0…
Skills: Aseptic technique, Cleanroom practices, cGMP, SOP compliance, Data integrity
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The Associate Clinical Country and Site Lead supports global clinical development strategy by providing local operational and scientific expertise. They serve as the primary point of contact for clinical sites, ensuring quality execution, patient safety, and effective investigator engagement.
Candidates must have a bachelor's degree and at least 5 years of clinical research experience, particularly in sponsor oversight within outsourced models. Strong knowledge of ICH/GCP regulations, project management skills, and the ability to travel up to 80% are required.
About This Role
The Associate Clinical Country and Site Lead (aCCSL) role will support the Clinical Country and Site Lead (CCSL) in providing global teams with detailed local operational and scientific knowledge to inform the overall clinical development strategy and will ensure that local opportunities and needs are thoughtfully integrated into operational plans.
At the country level, this role serves as a single point of contact for CRO staff, and QSDO/global teams. This is to enable the delivery of local clinical trials with focus on quality, patient safety, and oversight of monitoring activities and performance. The aCCSL role will also serve as a site escalation point for investigator concerns, including those related to data integrity, patient safety or issues which are unresolved by the CRO, for example, ensuring that these are communicated to the appropriate Biogen responsible parties. As assigned, the aCCSL may interact with FSP resources and support monitoring operations.
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 Quantitative Sciences & Development Operations (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 Worldwide Medical or local medical) to position Biogen as the company partner of choice for clinical trials.
Lead and/or support required local activities as part of agreed country and sites 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]
Primary country level QSDO/Biogen contact for all QSDO clinical studies, leading interactions to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO/FSP staff, and QSDO/global teams. Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones
Support special projects or other QSDO activities as a representative of CSO or Country
You are an experienced research professional with strong site management experience. You excel in building effective site relationships, driving site performance, and ensuring quality execution of clinical trials. The ideal aCCSL is highly collaborative and able to work cross functionally to support study start up, site engagement initiatives, resolve site challenges and maintain oversight throughout the trial lifecycle.
Bachelor’s degree or equivalent
5+ years clinical research experience including managing clinical trial activities desirable, especially sponsor oversight activities in an outsourced/FSP model.
Understanding of cross -functional drug development process and 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 skills, especially project management skills, with an ability to set clear goals, align priorities and execute on multiple tasks/activities.
Effective working knowledge of relevant IT tools to promote virtual team working.
Excellent knowledge of clinical operational activities/challenges across local geography.
Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities.
Strong communication skills, including 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)
Experience working in a fully outsourced and Functional Service Provider (FSP) models
This is a field-based country aligned role, strategically focused on providing key local operational and scientific expertise to drive global clinical development strategy, enable local partnerships that enhance global customer satisfaction (internal and external), and support the country focused delivery and execution of the R&D pipeline.
We are targeting the West Coast or Midwest Region.
Job Level: Management
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to 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 basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
