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.
- 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
Interested candidates are invited to forward their resume and cover letter to firstname.lastname@example.org.
While we thank all applicants for their interest, only those chosen for an interview will be contacted.