Aquinox Pharmaceuticals, Inc. is a late clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Our primary focus is anti-inflammatory product candidates targeting SH2-containing inositol-5'-phosphatase 1, or SHIP1, which is a key regulator of an important cellular signaling pathway in immune cells, known as the PI3K pathway. Aquinox's lead drug candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. In September, 2016, we began enrolling patients in a Phase 3 clinical trial in our lead indication, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Other indications are under consideration for future investigation. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.
Aquinox is publically traded on NASDAQ (AQXP) with offices in Vancouver, BC, Canada and in San Bruno, CA, USA.
The Location of the Position:
This position will be based in our San Bruno, CA office. Manager
Reporting to the Vice President, Clinical Operations, the Manager/Senior Manager, Clinical Operations is responsible for operational planning, implementation and conduct of assigned clinical trials outsourced to Clinical Research Organizations (CROs) and in compliance with applicable clinical and regulatory standards.
The Manager/Senior Manager, Clinical Operations will:
• Manage the planning and execution of clinical trials through CROs, preparing budget, scope and schedule requirements from protocol design to final clinical study report; anticipates problems and proposes contingency plans to ensure successful and timely completion of the trials
• Collaborate across a variety of functional groups including clinical, non-clinical, regulatory, CMC, product planning, contracts and finance to plan and execute responsibilities
• May assist in developing RFPs and the selection of CROs and other vendors
• May author clinical study reports and contribute to a variety of regulatory documents
• May contribute to the development of abstracts, presentations and other manuscripts
• May initiate, author and contribute to SOP development, implementation and training
• This position has project management responsibility and no direct reports, but will collaborate internally and with CROs to plan, execute and close out clinical trials
• Some international travel will be required
What you bring:
• Minimum 6+ years of experience in clinical research and a BS or BA in a relevant scientific discipline or Registered Nurse certification – knowledge and experience will determine level and title
• Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
• Working knowledge and experience with Word, PowerPoint and Excel
• Excellent interpersonal skills and demonstrated ability to lead is required
• Excellent verbal, written, interpersonal and presentation skills are required
• Creative problem solver with the ability to address issues quickly and independently, balanced with judgement to escalate issues as needed
• Strong attention to detail and dedication to accurate and high-quality work
• Focus on results, highly collaborative cross functionally, and proactive
Our current clinical trials, exceptional team, and strong track record make it an excellent time to seize this exciting opportunity! We provide a collaborative and innovative environment with competitive incentive packages and rewards. Moreover, we provide the opportunity to partake in meaningful work.