ASSOC. DIRECTOR/Clinical Science & Strategy（ACPD)

Major Responsibilities：

• Establish the Clinical Plan (CP) in the region
• Prepare the study concept according to the CP
• Ensure the best medical science parts is incorporated into the CP, such as protocols, CSRs, CTD clinical parts  (including publications)
• Oversee the ongoing evaluation of efficacy/safety
• Represent the company at meetings with Regulatory Authorities and/or partners as necessary
• Represent the company and speak at conferences and meetings with Key Opinion Leaders as necessary
• Ensure compliance of program/project(s) with all appropriate regulations, SOPs, company processes and ICH-GCP and quality standard applicable to UCB
• Lead interpretation of study results for phase transfer
• Construct the submission logic for clinical part of CTD/eCTD
• Lead and drive clinical submission team to establish quickest time from LPLV to NDA
• Collaborate with project teams (such as CST, EAST, CStT or strategic/technical aspects)

Requirement：

• Understands and applies scientific principles to trial design as well as data acquisition, analyses, and reporting. Applies fair balance in data interpretation.
• Depending on previous professional experience, more than 10 years of relevant experience in biopharmaceutical-clinical development is required, including oversight of the planning and simultaneous management and reporting of multiple clinical studies. 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).  Experience in critical review of relevant development and regulatory documents outside the clinical arena preferred. Current knowledge of most aspects of the global clinical development processes required and of the relevant therapeutic area preferred.
• Actual experiences for authorities’ review and negotiation processes to obtain approval are also preferable