Aquinox Pharmaceuticals Inc. is a private, venture-backed, pharmaceutical company developing novel and targeted small molecule therapeutics for the treatment of inflammatory disease. The company has a strong intellectual property portfolio and library of drug candidates that target a unique biochemical enzyme called “SHIP1”, which regulates the PI3 kinase pathway. Aquinox recently completed two Phase IIa clinical studies for its lead clinical candidate, AQX-1125. The Company’s outstanding technology coupled with an exceptional team, strong financing and track record make it an excellent time to seize this exciting opportunity.

Responsibilities

• Leads the design and conduct of phase I and II clinical trials including drafting and amending clinical protocols, overseeing data collection for clinical trials, as well as analyzing and interpreting data
• Directs and administers clinical development plans and budgets for clinical contracts
• Oversees the activities of principal investigators including negotiating arrangements for conducting clinical trials
• Identifies Key Opinion Leaders in related therapeutic areas and establishes relationships and collaborations as appropriate.
• Prepares and writes reports required for Regulatory Submissions, coordinating with Regulatory Affairs as appropriate

• Lead and monitor all internal and external staff and resources associated with clinical operations as well as CRO’s and vendors
• Works closely with biostatistics to interpret and analyze clinical trial results and outcomes
• Participates as member of management team in overall product development strategy development
• Participate as a member of AQX project teams, ensuring clinical operational challenges and issues are proactively identified and clearly articulated
• Oversees the monitoring of clinical trials, ensuring timelines and protocols are adhered to
• Participate in clinical protocol design, and amendments, and review all related documents
• Ensures GCP compliance as appropriate

Qualifications and Experience

• BS/MS in Life Sciences and a minimum of 10 years experience in Clinical Research; minimum 5 years of directly related experience in a similar role
• Preferred candidates will have a proven track record of diversified Clinical Operations/Development experience at the management level within a biopharmaceutical environment, overseeing all aspects of Clinical Operations.
• Must be a seasoned leader with the demonstrated ability to contribute to all levels of clinical development – from managing details, to strategizing about clinical trial design, to participation in partnering discussions and due diligence, is essential
• Demonstrated ability to analyze and interpret Clinical Trial Results
• Previous experience overseeing clinical trials within Europe and the US is necessary, along with a working knowledge of the EMEA and FDA clinical/regulatory environment. Knowledge/experience with Asthma/COPD trials is preferred
• A “make-it-happen” attitude, along with a strong commitment to teamwork, and initiative are required
• Demonstrated management and leadership skills
• Excellent judgment and decision making skills
• Effective oral and written communication skills along with strong problem solving abilities
• Effective organizational and negotiation skills

Applications

Interested candidates are invited to forward their resume and cover letter to careers@aqxpharma.com.

While we thank all applicants for their interest, only those chosen for an interview will be contacted.