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 email@example.com.
This position will be located in either our Vancouver, BC or San Bruno, CA office.
The (Senior) Clinical 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.
The (Senior) Clinical 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
- 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:
- Ph.D. in related discipline, along with 2-3 years of industry sponsored clinical development experience with a life sciences/biotechnology/pharmaceutical company is required
- 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) desirableis 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; experience in drafting de novo dcuments
- 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.
We thank all applicants for their interest; only those chosen for an interview will be contacted.