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Director - Clinical Science (Biosimilars)
vor 2 Wochen
**Job Description**:
The Director, Clinical Research contributes to BBU Data Generation, to assist the Global Head, Clinical Research, Biosimilars to plan and execute the Global biosimilar clinical strategy (EU and/or US and/or China and/or Japan and/or other territories), for end-to-end clinical development of biosimilars which may span initial asset acquisition to publication. The role is diverse and includes responsibility for internal, cross-functional and external communication, collaboration and alignment. Execution of strategic research, study planning, design and conduct is key, as is contributing to the long-term view of opportunities for expansion into new areas and/or creating new partnerships.
**Principal accountabilities**
1. Strategic Role:
Contribute to and support BBU Global Medical Data Generation strategy, in line with appropriate corporate and BBU goals and strategic imperatives.
- Support Global/Senior Director in development of strategy for expansion into new territories (China, US, other tbc).
- Support Global/Senior Director in assessment of potential assets for development.
- Support initiation of new external partnerships as required to deliver expansion activities pertinent to data generation.
- Proactively cultivate a working relationship with Biogen’s business partners to ensure continual progress with BBU Data Generation strategy.
- Proactively develop working relationships with Key Medical Experts, including Advisory Board members, academic research groups, and registry leads.
- Responsible for BBU Data Generation AOP for specified biosimilar product(s) across particular therapeutic areas.
- Collaborate closely with Biogen Affiliate BBU Medical Leads to promote input into BBU Medical strategy and ensure alignment between strategic plan and Global/local study initiatives.
- Contribute BBU perspective and input into Global governance (e.g. MRRC) processes and relevant Biogen SOPs.
2. Operational Role:
For BBU RCTs and CSTs:
- Lead cross-functional BBU team (Biostatistics, Medical Leads, Regulatory, Safety, others as applicable) to develop and author scientifically robust, fit-for-purpose, operationally feasible and clear protocols
- Oversee selection of vendors and take responsibility for ensuring correct conduct of all aspects of study from feasibility through to database build, data review and statistical outputs
- Co-Author study publications
For SRAs and IITs:
- Ensure quality of all study concepts prior to these being brought to governance (BCRC, MRRC), and provide input into protocols where appropriate.
- Ensure that all study governance (BCRC and MRRC) processes are followed for BBU-supported research (studies and registries).
- Support execution of research initiatives on time and to budget.
- Provide review of results and publications, where applicable.
**Qualifications**:
**Minimum Education & Experience Requirements**
- MD or advanced degree in a scientific discipline preferred. Scientifically and clinically astute with very strong strategic influencing, communication and project management skills.
- Approximately **10** years of drug development / clinical research experience. Expert in clinical study design and authoring study protocols and clinical reports.
**Knowledge & Skills**
- Deep understanding of the role of Phase III and/or IV studies at minimum, including RCT and non-interventional research, in clinical development and lifecycle management
- A sound understanding of cross-functional responsibilities in drug development and lifecycle management.
- Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.
- Ability to establish operational plans and support vendors in the execution of these. Requires a balance of scientific and operational/project management and team leadership expertise.
- Must be able to build effective relationships across the organisational matrix and with external partners, including academic and clinical experts and cross-culturally.
- Excellent project management skills, including risk assessment and contingency planning.
- Must have effective CRO management skills.
- Able to partner with other functions and both internal and external stakeholders.
- Excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
