A career at our company is an ongoing journey of discovery: our around 52,000 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
- 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.
What we offer: With us, there are always opportunities to break new ground. 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