Director, Clinical Operations
ABOUT ANGIOCRINE BIOSCIENCE (AB):
Angiocrine Bioscience (AB) Inc. (San Diego, CA, USA) is a privately held clinical-stage biopharmaceutical company with proprietary technologies consisting of a line of human engineered endothelial cells (E-CEL) intended for hemato-oncology and regenerative medicine applications. AB has one on-going Phase 1b study and plans to start another two to four Phase 1b studies in the next twelve months. The AB team is united and fueled by its passion and sense of urgency to bring new, breakthrough engineered cell-based treatments to patients suffering from dire, often life-threatening medical conditions.
ROLE & RESPONSIBLITIES:
The role of Director of Clinical Operations (DCO) is to lead the operational aspect of Angiocrine’s clinical trials. This position reports to the Chief Operating Officer with a dotted line to the Executive Director of Clinical Development.
AB is founded and funded by entrepreneurs. Consequently, we expect the successful candidate to feel and prize ownership—i.e., acting as an owner and being entrepreneurial. The DCO needs to be proactive and constantly looking to identify and solve operational issues, small and large. For example, this person would not hesitate to call rather than merely email people. The candidate will persist until he/she gets an action or a clear answer. This person will demonstrate incredible interest in the success of our trials, both in the enrollment speed as well as the quality of our data. If needed, this person will not hesitate to take a flight to a clinical site if the problem at hand requires personal, face-to-face interactions. AB contracts with CROs but places the onus of responsibility on the DCO. The DCO makes things happen rather than waiting for CRO personnel to take action. In return for shouldering complete accountability for AB’s clinical operations, the DCO will be making key decisions (unlike more mature or larger companies) and have a unique and major opportunity to put his/her personal stamp on the growth and destiny of AB.
- On time and on budget execution of AB’s clinical trials.
- If a problem forces delay or budget increase, the DCO is the person who comes up with potential solutions and gains support from AB leaders.
- Upon gaining leadership support, the CDO acts decisively and swiftly, using personal actions and skillfully mobilizing the CRO and/or the clinical site (whichever appropriate within regulations and ethics).
- Jumps in enthusiastically and effectively to complete documents related to clinical trials and clinical trial grants.
- Leads in the budgeting and negotiation with CROs with appropriate support from the COO, Finance and the CEO.
- Works effectively with AB physicians regarding current clinical trials as well as designs of new clinical trials. Organizes key meetings related to AB’s clinical trials, coordinating with AB project managers.
- Minimum of 2 years as clinical operations leader and an additional 5 years as field clinical research manager.
- Proven track record budgeting and managing CRO, laboratory, and other clinical trial partners.
- Expertise in GCP, ICH and FDA guidelines and regulations applicable to clinical operations.
- Experience with highly complex (e.g., rare disease, inpatient hospital) clinical trials.
- Trained and experienced medical writer (or equivalent experience).
- Proficiency with Microsoft Office suite and Microsoft Project.
- Appropriate educational degrees in healthcare sciences—Master’s level preferred but not necessary.
- Ability to travel, including visits to clinical sites, in a proactive yet judicious manner—anticipated to be within United States, approximately 25-40%.
- Enjoys a fast-paced, semi-virtual corporate environment where evolutionary changes are a constant and where proactive ‘can do’ attitude, sense of urgency and friendly personalities are prized.
- Must demonstrate passion and burning desire to proactively contribute to the successful clinical development of Angiocrine’s innovative therapeutic candidates.
Equal opportunity employer. Above description is not intended to be all inclusive or limit the role and duties of the successful candidate.