Aquinox 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. Our lead product candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Having successfully completed multiple preclinical studies and seven clinical trials with AQX-1125, we are now advancing towards pivotal trials with AQX-1125 in our lead indication of bladder pain syndrome / interstitial cystitis (BPS/IC). Other indications are under consideration for future investigation. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1.
Aquinox is publically traded on NASDAQ and has offices in Vancouver, BC and in San Bruno, CA.
The Senior Scientist, Clinical Research, will play a key role in our growing Clinical Research and AQX-1125 teams. This role will provide scientific and research direction while authoring and reviewing key documents in support of our expanding Clinical Development program.
This position may be located in our office in either Vancouver, BC, Canada or San Bruno, CA, USA.
Specifically, the Senior Scientist, Clinical Research will:
- Perform regular literature reviews to author and update competitive intelligence documents, for example, other studies in BPS/IC, other programs in urological or bowel disease and/or other indications
- Author and review 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
- Support clinical database lock activities, review of study results and results interpretation
- Ensure corporate and clinical slide decks and other materials are kept up-to-date with current information
- Contribute to authorship and review process for scientific publications and presentations
- Support the development of key opinion leaders to build relationships and scientific outreach
- Support global scientific collaborations with research networks, research institutions, patient advocacy groups and advisory boards
- Collaborate with Commercial and Investor Relations teams, develop communication plan for key Aquinox scientific and clinical data (e.g. abstracts, posters, manuscripts), and propose scientific questions to address based on literature reviews
- Contribute to the planning, conduct, and presentation of scientific data at Scientific, Investigator and Investor meetings and other fora
Support Clinical, Preclinical, Regulatory, Commercial and other teams with scientific and medical information to support Aquinox strategies and responses to internal and external parties.
Qualifications:
- MD, Pharm D or PhD in Immunology or related field required with minimum 10 years in Clinical Research or Medical Affairs or combination of related experience required
- Experience in immunology, urology and/or gastroenterology desirable
- Thorough knowledge of clinical trial design, methodology and statistical concepts required, preferably Phase I to III
- Familiar with interpretation and implications of non-clinical data in developing clinical programs
- Basic understanding of biostatistics as applied to clinical research
- Thorough knowledge of GCP and ICH Guidelines associated with clinical research and regulatory submissions (NDAs and/or BLAs, INDs), and other regulatory documents (CSRs, IBs and clinical study protocols) required
- Demonstrated ability to develop complex medical/clinical concepts
- Demonstrated initiative and results orientation
- 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
- Able to travel ~ 15% of time (e.g. to Scientific Meetings)