Senior Director Project Management Of Non-Clinical Studies

SENIOR DIRECTOR PROJECT MANAGEMENT OF NON-CLINICAL STUDIES

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

QUALIFICATIONS:

• PhD in biology, immunology, pharmacology, toxicology or related field.
• Expert in the field, PhD or equivalence in biomedical/pharmaceutical science with at least 5+ years’ experience in pharmaceutical/biotech industry in non-clinical development with strong toxicity expertise.
• Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D.
• Familiar with relevant ICH, FDA, NMPA and EMA/OECD guidelines/regulations with hands-on experience on planning and execution of IND programs.
• Rich experience with regulatory authorities on various topics about TOX, PK and IND-enabling studies.
• Regulatory writing experience will be a plus.
• Team oriented work ethic and ability to work in cross-functional teams.
• Excellent written and oral communication skills, fluency in English and Chinese.

• SME of Biologics non-clinical studies and related responsibility.
• Manage, direct and lead non-clinical projects in a team environment; Work with clients to proactively identify the right non-clinical strategy based on their unique program and help clients to design right studies, smartly coordinate the studies to move forward efficiently.
• Work closely with BD to support non-clinical contracts discussions with strong TOX/PK/IND background and communication skills.
• Monitor closely the progress of projects, coordinate with sponsors and internal experts to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs; Stay on the top of project with continues scientific and technical support; Proactively identify potential issues and provide the constructive expert input.
• Serve as an expert for all TOX/PK/IND-related discipline within company; Coordinate document package for IND filing.
• Initiate issue-oriented agendas to facilitate effective team meeting discussion and able to summarize and provide guidance on follow-up strategies to ensure timely resolution of outstanding items.
• Provide supervision on non-clinical Project Management team members.