Senior Director, Clinical Operations
The Sr. Director, Clinical Operations leads clinical operations programs, providing vision, management, and daily execution. Program(s) goals, milestones and deliverables are achieved via a close interaction and collaboration with all functional lines involved in clinical development. Responsibilities include operational leadership and successful execution of clinical trials according to regulatory guidelines, oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables; oversight and continuous improvement of department infrastructure through the development of SOPs, guidelines and the use of technology; facilitation of effective internal and external relationships, and achievement of project goals and objectives.
This position reports to the Vice President, Clinical Development
- BA/BS in related life sciences field and
- 15 years of progressive clinical operations experience in pharmaceutical/drug development, with a preference for antibody/biologics experience, and including 10 years of experience in study/program management.
- Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies
- Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors.
- Experience managing the clinical operations for drug across multiple therapeutic areas is a plus
- Expertise in the areas of drug development, operations and strategic planning; experienced with submissions from investigational new drug through new drug application filings and managing pre-clinical through all clinical phases.
- International experience is highly preferred.
- Track record of leading a cross-functional team in a matrix environment
- Willingness and capability to work effectively in a smaller pharma company (i.e. willing to roll-up your sleeves as necessary to help get the job done
- Experience in a hands-on early development role within a small organization is a plus.
- Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
- Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.