Job Purpose

• Coordinate outsourced actives with CROs.
• Design develop and manger execution of preclinical plan and ensure data quality.
• Develop and maintain own professional expertise, establish detailed plans for preclinical studies, including PD, PK and TOX, also support clinical trials.
• Efficiently communicate scientific results.
• Prepare, review and revise study reports to complete IND filing in China and ex China.
• Manger central lab for the method development and validation of large molecular, biomarkers, ADA and Nab.
• Work with CMC, RA, Clinical and Program manager groups for the timeline and risk evaluation of preclinical studies.

Major Accountabilities

• IND-enabling project design and management, and PK/PD, TOX expert responsibility.
• Manage, direct and lead preclinical projects in a team environment; work with CROs to proactivity identify the right preclinical strategies based on the program, and design right studies, smartly coordinate the studies to move forward efficiently.
• Monitor closely the progress of projects, coordinate with CROs and cross-functions to design appropriate studies to meet the regulatory requirements.
• Scientific and technical support for preclinical part, proactively identify potential issues and provide the constructive expert input.
• Prepare the documents package for IND filing.
• Search and prepare scientific reference for project needs.
• Participate in or lead the discussion of preclinical part during the internal or external project meeting.

Requirements

• Master or Ph.D. with at least 5+ years of industry research experience is required.
• Hands-on experience with various cell biology, molecular biology, immunology techniques, including but not limited to, maintenance of tumour cell lines, PCR, ELISA and flow cytometry.
• In-depth knowledge in biomarker, immunology or building animal models.
• Demonstrated planning and organizational skills with strong knowledge in R&D.
• Strong work ethic and an attitude of personal ownership, leadership and accountability for the success of a program.
• Familiar with relevant FDA, ICH, EMA and NMPA regulation with hands-on experience on planning and executed of IND programs.
• Good communication ability and ability to work in cross-functional teams.
• Excellent written and oral communication skills.

Job Purpose

• Responsible for maintaining study team SharePoint spaces, grant access to the team and update files in SharePoint for Inspection Readiness documents including team roster changes, updating version dates etc., and uploading of meeting minutes and any documents to SharePoint as required.
• Maintain Trial Master File (TMF) in accordance with SOPs. Update the trial and site information as necessary in Corporate Clinical Trial in a timely manner.

Major Accountabilities

1. Clinical Operation hard copy documents archive.

• Sort Clinical operation hard copy documents and maintain.

2. Tracking Clinical operation payments.

Ideal Background

Experience      

• 1-2 years clinical operation monitor experience.
• No special requirement for junior position.

Competency Profile

• Tracking CO payment to vendors, collaboration with finance, ensure get payment receipt on time.
• Bachelor’s degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse, BPharm).
• Working experience in pharmaceutical company.

Specific Professional Competencies

• Good knowledge in GCP.
• Good command of written and verbal English.
• Good communication and organization skills.
• Good and proactive working attitude.
• Value importance of teamwork.
• Ability to work independently.

Job Summary

• Position is responsible for decisions affecting the ultimate quality of the product, including regulatory compliance, data quality, patient safety, and investigator relations. Contributes to efficient and timely execution of clinical trials, thereby benefiting cost control, company reputation with future prescribers and patients, and future revenue.

Key Duties and Responsibilities

1.Scope

• Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the vendors.
• Develop, communicate and evaluate trial management plans to include trial team objectives, workflows and timelines.
• Supervise study conduct by regularly reviewing external vendors’ performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/or impact on budget.
• Perform other tasks as deemed necessary by the Company.

2.Communication

• Familiarize with the competitive landscape; engage with KOLs, investigational sites, and other relevant organizations and vendors.
• Work closely with the PL (Project leader), other team members and stakeholders as required and serve as the internal key contact for their assigned studies.
• Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution.
• Appropriately escalates issues in a timely manner and endures resolution.

3.Quality and Risk

• Ensure quality and adherence to the relevant HUA SOPs, GCP/ICH-GCP, regulatory guidelines and working practices. Support any audit/inspection activities to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
• Ensure a risk assessment is performed with Quality Department.
• Conduct QC visit to sites to ensure trial quality standards are maintained.

Qualifications

1.Experince and Knowledge

• Bachelor degree in relevant major. Advance degree is preferred.
• Above 5 years’ relevant experience in clinical development including at least 3 years’ team leadership.
• Must have a thorough knowledge of clinical research concepts, practices, and relevant resources.
• Regulatory and policy on drug registration in China, MAH, and GXP relevant.

2.Abilities

• Responsibility: response for company, project process, milestones, and tasks in own domain.
• Planning: able to systematically think and analyse the company's business development in relevant area of responsibility, and formulate corresponding plans; Timely adjustment according to the external environment to meet the needs of the company's business development.
• Decision- Making: make a correct decision based on the analysis and judgment of the external environment. Ability to fully and accurately analyse and evaluate the strengths and weaknesses, risks and benefits of different programs and to make decisions that are superior to those of their peers.

3.Skills

• Clinical trial management and team leadership.
• Proficiency in the Microsoft office suite.
• Good interpersonal skills.
• Excellent time management and organizational skills.
• Negotiation skills.