Senior Manager Clinical Research - Biosimilar Business Unit

Job Description

The Senior Manager Clinical Research Biosimilars coordinates and provides clinical, operational and administrative support to develop, initiate and follow up data generation projects including post-marketing studies (CST, NIS, SRA, IIT) and contributes clinical expertise internally and externally to optimise understanding of the disease area and Biogen products as appropriate. The Senior Manager Clinical Research Biosimilars is the main point of contact for interactions with Samsung Bioepis on TNFi assets and is responsible for collating and delivering all information and reports as needed to remain in compliance with the partnership Agreement, is integral to building and maintaining valued constructive partnerships with internal key stakeholders, external vendors (e.g., CROs and publication partners) and Investigators, and is the Data Generation representative on the Asset Team(s).  The Senior Manager Clinical Research Biosimilars may engage directly with external Investigators and/or registry Leads for purposes of information gathering and sharing, and in collaboration on study design. Further, he/she engages with colleagues in Biogen affiliates and offices across EU and globally, to ensure that the Biogen scientific and process requirements are adhered to. The Senior Manager Clinical Research Biosimilars utilizes his/her clinical and operational expertise to gather insights and to support research/data generation initiatives, ensures that clinical projects are reviewed and approved according to the prevailing SOPs, and is responsible for oversight and reporting on progress and budget tracking.

Job Description

• Responsible for coordination of execution and follow up of data generation projects (CSTs, SRAs, IITs, registries)
• Act as a member of cross-functional team in management of CSTs performed across different geographies, providing key support to Global Head Clinical Research Biosimilars  
• Strives to ensure timely generation of real-world data
• Coordinates the internal review and approval of data generation projects
• Acts as the point of contact for certain data generation projects executed across the region(s), informing key internal stakeholders e.g. Biogen Biosimilars Global Head of Clinical Research, Biogen Biosimilars Asset Team(s), Biogen Biosimilar Hub colleagues and external partners as applicable 
• Acts as the point of contact for external stakeholders (e.g. CRO, other vendors) to support RFP, protocol and contract development as appropriate
• Initiates and tracks SOWs and contracts related to data generation activities across the regions
• Tracks and reports milestone achievements of data generation activities across the region(s)
• Tracks the budget for data generation activities and ensures alignment with Biogen Biosimilars Hub central function in relation to the project financials
• Communicates and trains on clinical project processes to internal and external stakeholders (e.g. MLs, MSLs, Investigators)
• Operates in a confident and compliant manner within a highly regulated environment
• Stays up to date with therapy advances, current research, medical scientific knowledge and detailed knowledge on Biogen products & relevant disease areas

Qualifications

• 3-5 years research and operational strategy experience including responsibility for ensuring study execution to quality, timelines and budget
• Advanced scientific degree or equivalent experience. Strong scientific and analytical skills with demonstrated deep understanding of disease areas and learning agility that can be applied to multiple therapeutic areas. Scientifically and clinically astute
• Demonstration of project/programme management skills including risk assessment, timeline and budget management and contingency planning
• Demonstration of effective team leadership in cross-functional matrix teams. Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
• Experience in analysis and interpretation of clinical data and a basic knowledge of biostatistics and clinical study design
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• Excellent written and verbal communication skills

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflect