Aquinox Pharmaceuticals, Inc. is a 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, rosiptor (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 publicly traded on NASDAQ (AQXP) with offices in Vancouver, BC, Canada and in San Bruno, CA, USA.
The Clinical Research Scientist, will play a key role on our growing Clinical Research team. Reporting to the Senior Director, Clinical Development and Product Planning, this role will provide scientific and clinical research contributions to support our expanding Clinical Development programs.
This position may be located in our office in either Vancouver, BC, Canada or San Bruno, CA, USA.
The Clinical Research Scientist will:
- Provide scientific input on disease indications, trial designs and scientific rationale for compounds in development; perform regular literature searches and reviews to support scientific rationale
- Participate in cross-functional project teams, ensuring product development strategies are in line with current scientific and regulatory requirements
- Assist in drafting and reviewing scientific sections of clinical documents including protocols, investigator brochures, statistical analysis plans, informed consent forms, and clinical study reports and regulatory documents including INDs, annual reports, NDAs, briefing packages for Regulatory Authorities
- Participate in clinical data review to ensure quality, both during and following completion of clinical trials
- Support clinical database lock activities
- Contribute to critical evaluation and interpretation of study results
- Assist in ensuring clinical slide decks and other materials are kept up-to-date
- Collaborate on preparation of scientific publications and planning / preparation of presentations for Scientific, Investigator, Investor and other meetings
- Provide scientific input to cross functional teams such as Preclinical, Regulatory and Commercial to support Aquinox positions and responses to internal and external questions, including regulatory and ethics committee queries
What you bring:
- (Master’s or Ph.D.) in medical, health or related discipline, along with 1-3 years of experience in clinical research and/or biotechnology/pharmaceutical research
- Experience in pain, urology, ophthalmology and/or gastroenterology is an asset.
- Knowledge of clinical trial design, methodology and statistical concepts specifically in relation to Phase I to III trials
- Basic understanding of biostatistics as applied to clinical research
- Knowledge of GCP and ICH Guidelines associated with clinical research and regulatory submissions (NDAs, INDs), and other regulatory documents (CSRs, IBs and clinical study protocols) is an asset
- Ability to develop complex medical/clinical concepts as well as alternatives and solutions for a range of complex scientific problems
- Strong written and oral communication skills
- Ability to multitask and collaborate in a busy team-oriented work environment
- Creative problem solver with the ability to address issues quickly, independently, balanced with judgement to escalate issues as needed
- Strong attention to detail and dedication to accurate and high-quality work
- Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint).
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.
Interested candidates are invited to forward their resume and cover letter to firstname.lastname@example.org, indicating why you feel you are a fit for the Scientist, Clinical Research role at Aquinox Pharmaceuticals, Inc.
We thank all applicants for their interest; only those chosen for an interview will be contacted.