Your new company
Global Top Pharmaceuticals with amazing TA in.
Your new role
What you'll need to succeed
- Responsible for the operational strategy and overall execution of assigned clinical program(s) which includes focus on budget, timelines, contracts resource management and providing operational strategies in support of achieving clinical program objectives.
- Develop and actively manage clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets. Ensures compliance with SOP's, GCP and ICH guidelines.
- Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timelines projection, drug and budget forecast, safety plan, monitoring plan, study management plan, issue escalation and resolution plan).
- Responsible for the clinical section and overall development update for DSUR/annual report and Investigator's Brochure.
- Manage Clinical Operations financial planning/forecasting and budget management and monitor the budget against actuals.
- Manage CRO and site budgets, communicate deviations from budget projections, and propose solutions for budget deviations.
- Lead problem solving and resolution efforts. Provide dedicated and creative recommendations on how to meet goals and handle identified risks and deviations.
- Build and maintain strong sponsor and CRO team relationships for the success of clinical trial management.
- Collaborate with Marketing, Regulatory, Quality, and other functions to provide and collect critical input for evidence dissemination and reporting for regulatory submissions, clinical evaluations and other deliverables related to the product lifecycle management. This includes pre-clinical studies, risk management implementation, new product development processes and design history file development.
- Drive the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes.
What you'll get in return
- BS/BA degree in a scientific or health related discipline. Advanced scientific or equivalent experience (MS) preferred.
- Minimum of 7 years (10+ for Director) experience in drug development, clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget. (at least part of this time in a Biotech/Pharma environment is preferred)
- Demonstration of project/program management skills including risk assessment, timelines and budget management and contingency planning
- Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills
- Scientifically and clinically agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery
- Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired
- Strong interpersonal, verbal communication, including fluency in English and Mandarin to the point of being able to have clinical discussions in both languages
What you need to do now
- Extensive experience of clinical development / drug development process.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1218741