Associate Director/Director, Project Leader of Non-clinical Studies

KEY ACCOUNTIBILITIES:

Non-clinical project leader and biologics TOX/PK/IND expert responsibility.

Manage, direct and lead pre-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 signed based on 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 BioDev; Prepare document package for IND filing; Lead IND filings to NMPA, FDA, EMA, MHRA and globally; Search and prepare scientific references for project needs.

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 Study Directors with other expertise including PK/TOX and regulatory filing; Coordinate all non-clinical studies and IND filing by leveraging all internal and external resources.

REQUIREMENTS:

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 from discovery to clinical development and regulatory registration.

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.

EDUCATION (Indicate the mini. requirement & preferred discipline):

PhD in biology, immunology, pharmacology, toxicology or related field.

OTHER SKILLS, ABILITIES & EXPERIENCE:

A driven, energetic individual with experience of operating to the professional standards of a large pharmaceutical company.

Flexibility and entrepreneurial skills.

Good people interaction skills, ability to influence to other departments.

Outstanding presentation skills both verbally and in writing, able to communicate his/her points articulately.

Role model, high level of integrity and honesty both internally and externally.