San Francisco, CA, USA
$180K-$205K+ (flexible for the right candidate, +competitive bonus, relocation package, stock options and benefits)
about 1 year ago
Associate Director of Clinical Operations
Our client is an industry leader in developmental stage biopharmaceuticals that discovers and develops innovative medicines to deliver novel solutions in areas of critical medical treatment. They have a robust R&D pipeline of new investigational drugs providing treatments for chronic pain, cancer, and auto-immune diseases. They offer a collaborative, intellectually-stimulating environment in a rapidly growing company.
Essential Job Functions
- Strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and data collection activities
- Responsible for establishing and approving (with CRO, Program Executive or Clinical Managers) scientific methods for design and implementation of clinical protocols, data collection systems and final reports
- Responsibility for partnered programs in the areas of supply training, labeling, package design & pulmonary drug development.
- Oversee and lead adherence to protocols
- Interact with various inside/outside groups to facilitate clinical programs
- Select, develop, and evaluate personnel to ensure the efficient operation of the function
- Work on abstract problems across functional areas of the business.
- Identify and evaluate fundamental issues for major functional areas through assessment of intangible variables.
- Interact internally and externally with executive level management requiring complex negotiations of to influence policymaking
- Participate in corporate development of methods, techniques and evaluation criteria for projects, programs and people
- Responsible for the development and management of Clinical Development Plans (CDP) which includes timelines, budget, and resource requirements
- Develop and implement clinical program strategy and directs those systems and programs in order to meet Company goals and objectives
- Coordinate and direct outsourcing activities across program(s)
- Create and direct program advisory committees as needed, such as Program Advisory Committee, DSMB and/or expert consultants
- Identify program/resource gaps; devise and implement solutions
- Provide weekly enrollment and program updates to senior management
- Drive project risk analysis and develops solutions to a variety of complex problems
- Ensure Clinical Operations department effectively interfaces with key functional groups
- Remain current with medical developments and publications on similar and competitor products
- Mentor and develop Clinical Operations staff
- Direct internal staffing and performance management, including hiring, training, coaching and performance reviews.
- BS/MS degree in scientific discipline required, PhD in a scientific discipline preferred. Equivalent experience may be accepted.
- 8+ years’ Pharmaceutical development experience moving product candidates from Phase I through pivotal, with at least 5 years managing CROs
- 10+ years management experience is required
- Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
- Previous experience working with senior management is required.
- Extensive experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP preferred.
- Demonstrated self-starter and team player with strong interpersonal skills
- Must possess excellent project management skills