Current Opportunities
Department: Clinical Research
Job Title: Director, Clinical Research
Description:
The Director, Clinical Research will oversee the direction, planning, execution and interpretation of clinical trials/research and data collection activities.
Duties and Responsibilities
- Responsible for establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
- Direct human clinical trials, Phases I-IV, for Company products under development, with responsibility for adverse event reporting and safety monitoring.
- Coordinate and develop reporting information for reports submitted to the Food & Drug Administration (FDA), monitor adherence to protocols, and determine study completion.
- Frequent interaction with subordinate supervisors, customers and/or functional peer group managers and may also include interaction with senior management.
- Act as consult/liaison with other corporations when working under licensing agreements.
- Responsible for recruiting clinical investigators and negotiating study design and costs.
- Other duties may be assigned.
Job Requirements:
- Physician (M.D.) or Pharm.D. with a minimum of three years industry experience, to include experience managing clinical trials, including overseeing protocol design, safety reporting, interacting with investigators, writing and communicating study results, and participating in preparation of FDA submissions.
- Experience in acute or chronic pain management clinical trials highly desired.
- Ability to interact effectively with senior management, subordinate supervisors, customers and/or functional peer group managers.
- Ability to manage and mentor, acting as an advisor to subordinate(s) to ensure schedules are met and/or technical problems are resolved.
- Ability to provide expertise and experience to the clinical team through sound management skills and communicate clinically development goals cross-functionally.
- Ability to proactively identify problems and facilitate team solutions.
- Ability to develop and administer budgets, schedules and performance requirements.
- Ability to manage and coordinate the activities of a project(s) with responsibility for results in terms of costs, methods and employees.
- Excellent organizational and communication skills.
- Occasional travel is required.
Anesiva is an equal employment opportunity employer and promotes diversity throughout its workforce. Applications and resumes are considered for all positions without regard to race, color, religion, sex, national origin, ancestry, age, medical condition, physical or mental disability, marital status, sexual orientation, or veteran status.
