Summary:
My client is a global specialty pharmaceutical firm with operations in Europe, Australia, and, most recently, the United States. They serve as a dermatology rare disease focused group with all the benefits of a start-up, emphasizing the idea that your voice and ideas matter, all while holding the industry credibility of larger mid-sized pharmaceutical corporations.
Since their first clinical trial in 2006, my client has had success with three market approvals and has produced over $10 million in revenue in the second quarter for their commercial supply of medicinal items. As of now, my client has six indications in Phases II and III, one of which is nearing worldwide market approval.
The Director of Clinical Operations is in responsible for administering clinical research programs in Europe and the United States in accordance with ICH GCP guidelines, appropriate local and international regulations, and corporate SOPs to assure clinical program delivery on schedule.
Role Responsibilities:
- Consult with Executive Management to develop and agree on therapeutic initiatives.
- Plan, initiate, direct, and carry out the clinical programs of the organization.
- Identify and communicate with important opinion leaders to identify potential research investigators.
- Coordinate a number of clinical initiatives to meet agreed-upon deadlines.
- Study Feasibility Assessments - Coordinate with internal and external experts on suggested protocol scope, budget, and timelines as well as identification, evaluation, and selection of appropriate investigators/sites and other service providers in accordance with project needs and business SOPs.
- Document Management - Ensure that the necessary documentation are collected and compiled (in accordance with ICH GCP guidelines and company SOPs).
- Ethics Committee Documentation - Manage the timely preparation of required HREC/IEC applications.
- Pharmacovigilance - Manage adverse event reporting in accordance with regulatory obligations and company SOPs.
- Manage annual budgets.
- Manage a worldwide clinical team, including career development for each member, and track professional success.
Qualifications:
- Postgraduate degrees in biomedical sciences or medical degrees.
- At least 5 years of senior management experience in an international organization is required.
- Knowledge of the ICH GCP guidelines is required.
- Experience creating and administering clinical trial programs in Europe and the United States.
- Experience working with orphan drugs is preferred.
- Lives in San Francisco/Bay Area and able to comfortably commute to the office at least 3 times a week, as this is a hybrid role.
