Manager/Senior Manager, Clinical Operations
Aquinox Pharmaceuticals, Inc. (NASDAQ:AQXP) (“Aquinox”), is a clinical-stage pharmaceutical company discovering and developing novel drug candidates to treat inflammation, inflammatory pain, and blood cancers.
Aquinox's lead drug candidate, rosiptor (AQX-1125), is in Phase 3 development for the treatment of patients with interstitial cystitis/bladder pain syndrome (IC/BPS), a debilitating condition marked by chronic pain and urinary symptoms, for which there are currently few FDA approved and/or effective treatment options. Rosiptor has a novel mechanism of action, activating SHIP1 (SH2-containing inositol-5'-phosphatase 1), an enzyme that serves to down-regulate inflammation through its role in the PI3K signaling pathway. Rosiptor has been generally well tolerated in multiple completed clinical studies, with more than 395 subjects dosed.
Aquinox currently has approximately 60 employees in offices in Vancouver, B.C., Canada and San Bruno, CA., USA. We are a focused team, achieving our goals through our values based culture. Our people are highly results-oriented, proactive and collaborative.
Top line data from our Leadership 301 trial is expected in Q3, 2018. If this data is positive, Aquinox will be growing rapidly and adding to all departmental teams. If you are interested in speaking with us about this role and joining us after our data announcement, please send your cover letter and resume to firstname.lastname@example.org.
The Location of the Position: This position will be based in our San Bruno, USA office.
Reporting to the Director, 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 incumbent will focus initially on phase 1 and 2 clinical trials.
The Manager/Senior Manager, Clinical Operations will:
• Manage the execution of phase 1 and/or 2 clinical trials through selected CROs from study start-up to final clinical study report; anticipate problems and propose risk mitigation plans to ensure successful and timely completion of the trials.
• Oversee CRO study conduct to monitor adherence to regulatory requirements, GCP per relevant contracts.
• Oversee CRO generation of applicable clinical documents, study-related manuals and procedures.
• Provide oversight and input to additional study-related external vendors, including execution of work and tracking of milestones and deliverables.
• Participate in Request for Proposals (RFP) and in the selection of CROs and other applicable vendors.
• Collaborate across a variety of functional groups including Clinical Development, Biostatistics and Data Management, Regulatory, Drug Supply, Project Management, Contracts and Finance to plan and execute responsibilities.
• Perform study site visits to provide Sponsor-level support as required.
• Provide clinical input to protocol and other documents as required.
• May assist with Standard Operating Procedure (SOP) development and implementation.
• This position has some 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 trial management for industry sponsored trials, along with a Bachelors of Science, Arts or other degree in a relevant scientific discipline is required. Experience as a clinical research monitor is an asset – 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.
We thank all applicants for their interest; however, due to the volume of resumes we receive, only those chosen for an interview will be contacted.