Job Code:
Location: Western US

Requirements:

BS, MS, or PhD or equivalent in scientific discipline is required. Strong clinical operations experience and demonstrate a thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing are also necessary.

Candidates must have 10 years of progressive experience in Clinical Operations with strong background in pharmaceutical and biotech clinical research and experience in the therapeutic areas of oncology and/or inflammation.

Description:

Proficient protocol design experience and knowledgeable in the entire FDA approval process as it relates to clinical trials are desired. In addition, a thorough understanding of FDA, GCP and ICH guidelines with a track record of success in the liaison role with investigators and sponsors are required. Candidates must also have strong organizational/project management/interpersonal skills, strong writing and computer skills & be performance oriented individuals.

The Director/Sr Director Clinical Operations will responsible for the operational oversight of clinical development programs within therapeutic areas. This person will have management responsibility for their clinical operations staff, as well as resource management responsibility for their programs. This position is a key role with strategic and technical influence on drug development. This position is also responsible for formulating and executing the operational aspects of the company’s clinical trial program. Job responsibilities will include:

- Developing study documentation, including; protocols, amendments, investigator brochures, CRFs, informed consent forms, IND and IRB submissions as they relate to the clinical data/programs.
- Developing and/or monitoring standard operating procedures for internal personnel and for external contractors
- Ensuring proper collection of required documentation
- Developing and managing project and departmental budgets
- Write and review clinical study reports

This position will also manage and develop the clinical team, including clinical project managers and clinical research associates. In addition, the successful candidate will determine priorities, hiring strategies, staff training, act as an external liaison and assist with recruitment of qualified investigators.

The position will be responsible for ensuring that site recruitment, initiating objectives and patient enrollment targets are met.

This person must work with the clinical operations staff to perform site monitoring visits and manage vendors, including central laboratories and CROs, as well as assist with clinical trial monitoring.

Participation in all aspects of clinical trials, including determining development strategy, serving as a member of Development Teams and assisting in communications and publication will be expected