Director, Clinical Science, Biosimilars

Job content

The Director, Clinical Science

Job Description

Applies technical, pre-clinical and Phases I and III reference and biosimilar expertise to:

• Drive evaluation of analytic and clinical data relevant to new biosimilar acquisition and development plans in all Biogen global territories, as part of Pipeline Due Diligence
• Drive technical aspects of clinical development pathway and advise the BBU Clinical Development Team (CDT) on PharmacoKinetics (PK), assay and biosimilarity assessment at the study and programme level, for all new biosimilar asset development
  

Provides technical review of reference product material, specific to each biosimilar asset development plan, including input into regulatory engagements and dossiers, and including engagement with specialist external experts.

Identifies research approaches that span programmes, partnering with external experts/SMEs, Biogen Global technical and BBU CDT colleagues, to promote biosimilarity evaluation as appropriate.

Principal Accountabilities

• Partners with cross-functional New Assets team, Global Head, Clinical Research, Biosimilars, external experts, BBU CDT and other BBU/R&D functions to:
• Provide technical assessment of pre-clinical material as part of new biosimilar asset acquisition Due Diligence
• Apply knowledge of regulatory guidelines to develop scientifically robust and clear technical content for incorporation into biosimilar development plans, protocol concepts/protocols
• Influence biosimilar development study/programme direction based on changing internal and external landscapes within Phase, disease or therapeutic area
• Provide input into biosimilar study design, including rationale for technical aspects, end points and patient population, ensuring that scientific integrity is not compromised
• Secures scientific excellence for biosimilar development programmes by:
• Independently applying a deep understanding of the external landscape/historical development course of reference product and associated drug development dependencies to advise on biosimilar development strategy
• Building a rich knowledge of specific Area(s) of Expertise applicable to a biosimilar development plan, being SME for the cross-functional Due Diligence/Asset teams and being recognised/leveraged across other BBU programmes for their technical expertise
• Utilising technical expertise and scientific assessment to assess end point measurement options, and ensure the appropriate incorporation into biosimilar clinical development programmes and eCTD content
• Ensuring that the biosimilar development plan includes appropriate risk mitigation plans specific to technical aspects
• Authoring and providing technical content for regulatory documents, including Briefing Book(s) and eCTD Modules, to ensure quality interactions when seeking scientific advice from Competent Authorities (globally) and when preparing BLA/MAA/other Competent Authority dossiers
• Strives for effective, consistent, efficient and compliant processes by:
• Identifying interdependencies and synergies across biosimilar development plans/programmes and seeking to proactively develop and refine processes to enhance excellence in new asset evaluation
• Seeking ways to improve and streamline processes to support the biosimilar development pathway; provides feedback via appropriate channels for opportunities to improve processes or set best practices
• Embodying a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the cross-functional team model
  

Qualifications

Minimum Education & Experience Requirements

• B.A. or B.Sc. in a scientific discipline; advanced degree preferred.
• Scientifically and clinically astute with very strong technical knowledge.
• Approximately 12 years of clinical research experience, including in the field of biologics/biosimilar development.
• PharmacoKinetics (PK) and immunogenicity experience with biosimilars mandatory
• Previous experience/focus on technical assay/biomarkers is advantageous.
  

Knowledge & Skills

• Deep understanding of biosimilar clinical development
• Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas
• Requires in-depth scientific and technical knowledge as applied to biologic/biosimilar development
• Must be able to build effective relationships across and up and down the organization, within and outside BBU
• Excellent project management skills, including risk assessment and contingency planning
• Able to partner with other functions and both internal and external stakeholders
• Excellent communication and organizational skills, along with problem solving, conflict resolution, and team building skills
• Thorough knowledge of ICH guidelines and regulatory requirements for biologic/biosimilar clinical development
• A sound understanding of cross-functional responsibilities in drug development