Director of Clinical Operations
Location : Newtown PA US 18940
Job Type : Direct
Reference Code : 19163-AB1
Compensation : 150000.00 - 190000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 10
Required Education : MS Life Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position with a pharmaceutical company specializing in rare disease treatment for Director of Clinical Operations.with complete responsibility for clinical operation strategies and delivery of all phases of clinical study portfolios while adhering to Good Clinical Practices (GCPs) and applicable regulations.
- Oversee CROs and other external vendors to ensure studies are conducted under budget, on time, and within quality measures.
- Manage Clinical Study Managers with their studies and assist the Clinical Research Executive Director in heading the Global Clinical Development (GCD) program.
- Design, update and implement appropriate innovative clinical study development best-in-class procedures and SOP's, in collaboration with Quality Assurance.
- Provide training and ensure all Clinical Study Managers understand and execute all processes, policies and procedures.
- Develop and oversee employee development, including hiring, training, feedback, and career development.
- Lead the development of contingency/risk management plans for projects.
- Assist the Executive Director of Clinical Operations in preparing sound development strategies.
- Manage the day-to-day operations for clinical studies.
- Review, select, approve, and ultimately manage CROs and external vendors.
- Conduct vendor on-boarding and management throughout studies.
- Establish metrics and other tools to monitor overall CRO operational performance.
- Review study feasibility assessments provided by the CROs and negotiate performance-driven budgets and contracts.
- Participate in clinical project teams as needed.
- Ensure all deliverables are delivered with the best quality according to all established contracts and Service Level Agreements.
Required Qualifications :
- MS or PhD in Life Sciences
- Minimum 10 years of Clinical Operations experience.
- Minimum 5 years hands-on management of a clinical operations group.
- Understanding of clinical development process and GCP.
- Strong and proven collaborative, negotiation, and influencing skills.
- Ability to lead, empower and mentoring staff.
- Dedicated, results-oriented self-starter with a high energy level.
Contact: Allan Berman