?Contribute to therapeutic area and clinical development strategy within Evive portfolio. ?Direct the creation of clinical development plan to translate the overall strategy into an executable plan. ?Accountable for providing medical oversight on clinical trials and ensure that all studies meet regulatory requirements and are compliant with all policies, SOPs and GCP guidelines. ?Provide medical and scientific expertise on medical project and communicate with study teams and key stakeholders internally and/or externally. ?Accountable for generating or review clinical documents such as CDP, protocols, IB, CRF, CSR, SAP, etc. ?Provide medical review and approval of clinical documents for regulatory submissions, i.e. Pre-IND briefing documents, IND and NDA submission, annual reports, etc. ?Build an efficient and talented medical group in US and streamline the medical procedures. Attract and develop talent, coach others to higher levels of performance. ?Establish and foster strong professional relationships with KOLs, study investigators, academic scientists, and consultants mainly in US. ?Provide medical assessment of in- and out-licensing opportunities of development projects.
Qualifications: ?Medical doctorate degree or equivalent degree is required. Subspecialty training and advanced knowledge in a medical area (for example internal medicine) is strongly preferred. ?3-5+ years of clinical research or drug development experience working in a pharmaceutical/biotech company. ?Strategic thinking and highly effective analytic skills. ?Must have excellent communication, influencing and presentation skills (verbal and written). ?Excels in organizational agility and cross-functional approach. ?Leadership and people management skills.
投遞簡歷
400
