For the assigned program/project(s) with minimum support by function head / seniors:
1. Lead the research/development Team, including but not limited to: stakeholder management, team alignment, team meeting and communication, team setup and deliverable status check, collaborate with other project teams.
2. Work with the team and stakeholders to develop product development plan
3. Contemplate study design for each clinical trial and prepare study concept according to the development
4. Ensure the best medical science parts are incorporated into the development plan of the assigned projects
5. Oversee the ongoing evaluation of study efficacy/safety and data quality, effectively and efficiently interact with partners, key opinion leaders and investigators.
6. Drive the implementation of the CDP for timeline, budget and deliverables; provide technical guidance to the operational team when needed; identify potential risks and manage any challenges that may occur.
7. Lead the team in data analyses and result interpretation for studies.
8. Represent the company at meetings with Regulatory Authorities and/or partners as necessary.
9. Represent the company and speak at conferences and meetings with Key Opinion Leaders as necessary.
10. Ensure compliance of program/project(s) with all appropriate regulations, SOPs, company processes and ICH-GCP and quality standard
11. Construct the submission logic for clinical part of CTD/eCTD and any other regulatory documents.
12. Lead and drive clinical part of submission team to establish quickest time from LPLV to NDA.
Education Level: Master and above
1. Understand and apply scientific principles to the development strategy / trial design as well as data acquisition, analyses, and reporting. Apply fair balance in data interpretation.
2. Depending on previous professional experience, more than 5 years of relevant experience in biopharmaceutical-clinical development (or equivalent) is required including the followings:
a) Oversight of the planning and simultaneous management and reporting of multiple clinical studies.
b) Broad experience in writing and/or participation in the preparation of submission documents required (across or at timepoints along the continuum from original protocol to NDA/PLA to safety updates).
c) Experience in critical review of relevant development and regulatory documents outside the clinical arena preferred.
d) Current knowledge of most aspects of the global clinical development processes / global studies required.
e) The knowledge of relevant therapeutic area preferred.3. Actual experiences for authorities' consultation, authorities' review and negotiation processes to obtain approval are also preferable