• Provide a leadership role in country/region clinical resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with study team leadership and operational peers.
• Evaluate the quality of the clinical work product for a variety of job roles and/or a specialized job function. Evaluate regional workload, quality and budget metrics through regular review and reporting of findings. Collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for clinical projects.
• Act as a coach and mentor for junior staffs as they develop in their roles. Work collaboratively with project leadership including the PM, client representatives and other functional leadership to manage project related challenges and to achieve exemplary customer service.
• Analyze and review budgets for clinical studies within region. Pro-actively plan for appropriate clinical operations budget consumption and guides line managers and CRSs in managing variances and in developing corrective fiscal action plans.
• Conduct Clinical Project Review and participate in Project Management Review according to regional guidelines and interfaces with appropriate functional leadership to achieve positive outcomes.
• Provide strategic and tactical direction to multiple project teams
• Work closely with clinical sites, CRAs, CROs, and other departments to create clinical study documents.
• Evaluate new CROs and other vendors for conforming with Innocube Biosciences Inc., or Lepu Biopharma Inc. quality controls.
• Review, summarize and integrate complex data sets across multiple disciplines.
• Manage preparation and presentation of nonclinical safety data for project teams, portfolio management presentations, and internal /external partners and scientific groups.
• Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of results on program and clinical/regulatory strategy.
• Generate annual budgets to support clinical study programs.
• Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates and to develop program budgets.
• Maintain a current understanding of regulatory requirements and guidance.
• Participate and may lead corporate or departmental quality or process improvement initiatives.
• May act as a client liaison.
• All responsibilities are essential to job functions unless noted as non-essential qualifications.

Supervisory Responsibility:

This position has supervisory responsibilities.

Travel:

Travel may be required to visit the parent company, customers, related organizations in US, China and elsewhere, etc., about 30%.

Direct Report to: [Global CMO]

Work Environment:

The employee will perform the job in an office environment, or remotely

Physical Demands:

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Extensive use of keyboard requiring repetitive motion of fingers.
• Regular sitting for extended periods of time.

Required Technology:

• Strong MS Excel, Word, and PowerPoint skills
• Strong problem-solving skills and attention to detail

Required Education and Experience:

• Bachelor's degree in a health care or other scientific discipline or educational equivalent; 12 years of clinical trials experience including 7 years experience in a leadership capacity; or equivalent combination of education, training and experience”.
• Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods.
• Strong leadership skills.
• Effective presentation skills.
• Strong written and verbal communication skills including good command of English.
• Excellent organizational and problem solving skills.
• Effective time management skills and ability to manage competing priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Qualifications:

• Able to identify and resolve key issues.
• Highly accountable.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Contact E-mail:

Interested parties please send your resume to

HR email:lpswhr@lepubiopharma.com, HR@innocubebio.com