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Director, Clinical Operations
Job Type: Full-time
Date Posted: Wednesday, 20 January 2010
Location: California
Number of Openings: 1
Education Level: University
Job Description: Position Summary:

This person will be responsible for managing the overall operations of the Clinical Department including project planning, budget, resource management and contract research organization management. Responsibilities also include participating in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, periodic reports, INDs, and NDAs.

Clinical Operations Responsibilities:

1. Manages all the operational activities of clinical studies.
2. Serves as point of contact for internal and external customers.
3. Develops and maintains clinical study timeline, metrics and other management-reporting tools.
4. Distributes and delegates clinical project work.
5. Assists with forecasting investigator enrollment, investigator grant budget and clinical trial budgets.
6. Creates, updates, and maintains the operations and procedure manuals, standard operating procedures, work guidelines, project documentation files, records and application files.
7. Participates directly in all study activities, including protocol review, development of study materials, packaging and labeling, clinical trial site selection and interaction, contractor and CRO selection and management and safety reporting.
8. Provides leadership through effective objective setting, delegation, communication, and role modeling.
9. Provide technical training and mentorship for the development of clinical documents (protocols, monitoring plans, clinical trial reports, investigator brochures, and trial conduct).
10. Lead the development of clinical documents such as protocols, investigator brochures, study reports, and annual reports.
11. Ensures compliance with protocol, regulatory and overall clinical objectives.
12. Take a lead role in presenting data at investigator meetings.
13. Cooperates in interdisciplinary teams (R&D, Regulatory, Pharmaceutical Sciences) and ensures that timelines are met, conflicts resolved, and projects are kept on time and within budget.
14. Participates in interviewing, selecting and training clinical staff.

Monitoring Responsibilities:

1. May monitor clinical study sites, including qualification, initiation, interim monitoring, and close-out visits.
2. Contributes to the preparation and finalization of clinical study protocols, final clinical study reports, and clinical summaries.
3. Coordinates, prepares and compiles materials for clinical study conduct including, model informed consent forms; study manuals; case report forms (CRF’s); clinical monitoring plan; data audit worksheet; clinical monitor safety evaluation guidelines; site regulatory binder; budget worksheet; subject status tracking and reference information for investigational sites.
Qualifications: 1. Bachelor’s degree in a scientific, health care field (nursing, pharmacy, physician assistant) or related field, advanced degree a plus.
2. 10 plus years of experience in the pharmaceutical, biotech industry including project management and relevant clinical research experience, specifically in the area of CNS. Experience level is negotiable with an advanced degree.
3. Expertise in clinical drug development, operations and strategic planning, specifically management of clinical trials operations in Phases I-IV.
4. 2 years of experience in working as a Director of Clinical Operations for a small biotechnology company.
5. Demonstrated ability to see the “big picture” while not losing focus on specifics.
6. Must have knowledge in reference to Good Clinical Practices (GCP) regulations and standard operating procedures and maintains a high level of professional expertise through familiarity with clinical literature.
7. Experience with design and conduct clinical studies and training programs.
8. Experience developing and tracking appropriate metrics to assess clinical operation performance.
9. Strong project management skills and the ability to juggle multiple tasks of varying priorities and function in a fast-paced entrepreneurial environment.
10. Demonstrated ability to deliver results, sound decision making skills and the capacity to establish and maintain effective working relationships with colleagues and team members.
11. Willingness to fully engage with a high energy team in pursuit of organizational goals and strategies.
12. Strong verbal, written and overall communication skills including working computer proficiency.
13. Strong interpersonal skills with the ability to deal effectively with all levels of management within Transcept and its staff, as well as with outside constituencies.
14. Position will require up to 40% domestic travel.

More Information: email: hr@transcept.com
 
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