The Associate Director (AD), Clinical Operations is responsible for the planning, execution, monitoring and reporting of clinical research programs regionally for assigned products and indications. Programs will be conducted in compliance with all relevant regulatory regulations and guidelines to achieve strategic and operational departmental objectives. The AD will be responsible for managing the organization and conduct of regulatory and non-regulatory clinical programs in compliance with Clinical Operations policies and procedures, Regulatory Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives.
- Provides Clinical Research expertise input and leadership to cross functional project teams for assigned products and indications.
- Develops and maintains strong business relationships with sponsors and key opinion leaders.
- Responsible for the overseeing and coordinating the timely development of all essential project documents including project plans, protocols, informed consent forms, case report forms, and monitoring tools.
- Selection and management of external service providers to ensure project objectives are met within required timelines and budget through vendor contracting process.
- Ensure that clinical projects are conducted in compliance with all relevant regulations and guidelines.
- Conduct quality control visits to external service providers and investigational sites to assure regulatory compliance.
- Communication with Director, Clinical Research on project status, budgetary status, critical issues and challenges.
- Develop collaborative alliances and relationships with external service providers, investigators, key opinion leaders and advisors.
- Lead the planning and implementation of sponsor and investigator meetings and advisory boards in conjunction with external service providers.
- Contribute to clinical trial reports.
- Author and contribute to scientific publications and presentations for journals and symposium.
- Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
Applied Knowledge & Skills:
- Proven ability to lead a team and to work as a team member in a cross functional project team.
- Exhibits an open and constructive leadership style with the knowledge to escalate issues that require supervisory input.
- Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
- Has a "hands on" solution orientated approach with a strong sense of urgency and a "can do" attitude.
- Good computer skills including knowledge and experience of Microsoft Office applications.
- High degree of accuracy and attention to detail.
- Well-developed oral and written communication skills.
- Excellent presentation skills.
Problem Solving & Impact:
- Demonstrates good judgment, analytical thinking and problem solving and can differentiate between critical and non-critical issues to manage appropriately.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Decisions may affect a work unit or area within a department.
- Ability to read, interpret and develop clinical protocols and all associated materials.
- Ability to write clinical reports, protocols, business correspondence, and procedural manuals.
- Excellent communication skills, including effectively presenting information and responding to questions from project teams, external vendors and clients.
- Ability to establish and maintain systems and processes necessary to control and report trial status and activities.
- Ability to ensure that quality, regulatory-compliant clinical projects is conducted on time and within budget.
Supervision Given / Received:
- Provides strategic contributions on business and operational decisions.
- Serves as team lead to more than one team simultaneously.
- Typically reports to a Director.
- Bachelor's Degree or its International Equivalent • Biology, Chemistry, Clinical Trials, Life Science, Sciences or Related Field.
- At least 10 years' experience in clinical development gained in a CRO, Pharmaceutical or Biotechnology company.
- Excellent knowledge of the drug development process from pre-CTA/IND status through to post approval marketing studies.
- Good understanding of clinical research regulations and guidance in US, Europe and other international territories.
- Experience in third party service provider selection, contracting and management.
- Experience in managing budgets and familiarization with financial forecasting and cost accrual processes.
- Successful experience of operating in a resource constrained work environment.
- Global project management experience preferred.
Typical Physical Demands:
- Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, fax machine, cell phones, PDAs and other hand held devices.