A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
- Act as medical-scientific study lead in close collaboration with the clinical program lead and the Asian strategy clinical lead:
- Develop and/or oversee medical/scientific input to the creation of relevant clinical documents or parts thereof to ensure high quality in close collaboration with the program clinical lead and Asian clinical lead of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
- Review and sign off all clinical documents in close collaboration with the clinical program lead and Asian clinical lead related to the clinical studies (e.g. Concept sheets, study protocols; CRF development and study reports) within area of responsibility.
- Manage the clinical team supporting the clinical trial
- Is responsible for all medical scientific aspects including medical monitoring (oversight of a CRO) of the trial and provide respective guidance to the trial team.
- Oversee all aspects related to the scientific and medical risks in collaboration with the safety representative
- Lead the review, analysis and interpretation of study data.
- Lead the review, analysis and interpretation of relevant regulatory related documents, such as clinical part (including efficacy, safety documents) of CTD, CTA, NDA or briefing book for regulatory meeting.
- Support communication of study results or relevant to clinical development, such as manuscript, abstract or presentation for scientific and medical congress as assigned.
- Lead, oversee and support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring.
- Support biomarker strategy in close collaboration with the global biomarker team.
- Act as member of the Clinical Team in China:
- Lead clinical input for assigned study product(s) in order to establish its safety and efficacy and support registration in the shortest possible time worldwide
- Develop, and prepare study concept sheets, and study protocols in collaboration with clinical and project team members for assigned study in close collaboration with the Asian clinical lead and/or clinical lead.
- Present the Concept sheet to review board e.g. “Therapeutic Area Review Board” (TARB) and in Integrated Clinical Study Committee (ICSC).
- Collaborate with clinical trial management members in the selection of principal investigators and recruitment of clinical study sites in close collaboration with the Asian clinical lead and/or the program clinical lead.
Who you are:
- Regional responsibilities for global studies
- Provides clinical and scientific input during clinical team meeting lead by the Asian clinical lead and /or clinical lead of the program.
- Provides for global studies regional input during the concept sheet and protocol development.
- Support the ongoing global studies in the region by interacting with the reginal study PI, and if needed by interacting with the regional investigators (e.g. for safety or other study related medical topics) in close collaboration with the global study lead.
- Is responsible in close collaboration with the study lead for regional investigator meetings including planning in close collaboration with the CTL.
- Gives input for study related translations research questions (e.g. biomarkers) strategy for translational study, if needed
- support registration in the shortest possible time worldwide
- Provide reginal clinical input in submission strategy and dossiers development, regulatory authority communications
- Support business development activities: participate in Due Diligence activities and prepare Due Diligence Report in collaboration with Senior Medical Director
- Externally: Liaise with (principal) investigators, consultants, opinion/thought leaders, health authorities, IEC/IRB, Scientific and Patients’ Organizations and academic institutions in area of responsibility
- Internally: With the global clinical lead and the Asian lead Participate in cross-functional study teams meetings to provide medical/scientific input and in reginal Asian team meetings to provide medical/scientific into e.g. business plan, as assigned, as a clinical team as a reginal representative, main interface with other internal Departments/Functions including Biostatistics, Business Development, Business Unit/Marketing, , Clinical Trial Management & Monitoring, Data Management, Drug Safety, Exploratory Medicine, Research and early development, Legal, Medical Information, Medical Writing, Project Management, Regulatory Affairs, R&D Quality Assurance.
Functional area: Research and Development
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com