External clinical development expert (m/w/d) – Freelancer 100% Remote (on hold)

Details

Description

Responsibilities and tasks

•Contribute to the clinical development due diligence for a Phase 3 – preNDA stage fertility BD opportunity, which is a hormone controlling approach for assisted reproduction technology (ART)
•Provide medical-scientific input for clinical trial design, data interpretation, possibility of success (PoS) evaluation, etc. This includes (but is not limited to) conducting a thorough review of the clinical data package: both Ph2 and Ph3 results. Review documents provided by potential BD partner and provide independent opinion by generating DD report and attending DD meetings
•Share knowledge and information with a large cross-functional DD team, e.g. Medical Affairs colleagues for a fact-based evaluation
•Identify potential risk and challenges associated with the asset and its clinical development pathway, and propose mitigation plan with timeline & resource needed

Skills

•Fluency in English is required.
•Proficiency in Mandarin is a plus.
•Strong leadership competencies and communication skills to work with cross-functional team
•Experience in GCP clinical trials as an investigator or sponsor role
•At least 10 years working experience in clinical practice, international pharmaceutical industry, biotechnology sector or Contract Research Organization, and experience in Corporate R&D.
•Recognized expertise in clinical drug development through all phases (phase I to IV) in China
•General knowledge of clinical research methodology, clinical trial design and data interpretation, good understanding of the concepts of statistical analysis
•Hands-on experience of clinical trial management
•Thinking logically and strategically 2
•Experience in obstetrics and gynaecology / female infertility area, especially ART, will be a strong advantage

Information
Project start: 18.11.2024
Project end: 31.01.2025
remote: 100% ( China preferred)
Part-time: estimated at 4 hours per week/ total of 50 hours

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