Associate Director/Director, Clinical Data Management

 

About Aquinox

Aquinox Pharmaceuticals, Inc. is a late 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, rosiptor (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 rosiptor (AQX-1125), we are now in a Phase 3 program with our lead indication of 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. 

We are a focused team, achieving our goals through our values based culture. Our people are highly results-oriented, proactive and collaborative. 

Aquinox is publicly traded on NASDAQ (“AQXP”) and has offices in Vancouver, BC, Canada and in San Bruno, CA, USA.

The Opportunity

Reporting to the Senior Director, Biostatistics, and working out of the San Bruno office,   the Associate Director/Director, Clinical Data Management, directs the design, documentation, testing, implementation and archival of data from all clinical studies at Aquinox, in accordance with industry best practices and regulatory requirements.

The Associate Director/Director interacts with contract research organizations (CROs), external study coordinators and physician investigators and all levels of internal staff in highly cross-functional project teams, acting as the lead in designing, implementing and documenting data collection for multi-national clinical studies.

Specifically, the Associate Director/Director will:

  • Plan data management activities by reviewing protocols for cross-project consistency and identifying standard data collection processes to meet objectives.
  • Collaborate with other departments including Clinical Development and Clinical Operations to provide early strategic input into protocol design focused on data management issues.
  • In accordance with project governance standards, act as internal study data manager and primary liaison between the internal study team and external vendors and contractors.
  • Develop data quality plans, including risk-based monitoring, in conjunction with other members of the clinical study team.
  • Develop case report forms (paper or electronic), annotated CRFs, CRF completion guidelines, data management plans, data transfer specifications and data review guidelines, and integrates external data into the clinical database.
  • Train sites in data collection, entry and cleaning directly at investigator meetings and/or indirectly through site monitors.
  • Develop systems for organizing data to analyze, identify and report accumulating data and trends.
  • Initiate and compile trial master files containing all necessary documentation.
  • Establish conventions and quality expectations for clinical data and tracks the content, format, completeness, quality and timeliness of data collection activities throughout the conduct of the trial.
  • Lead medical review of the data by providing listings as agreed by the clinical study team.
  • Review and resolve data discrepancies for standardized data validation systems and procedures.
  • Ensure that the study database is locked according to planned timelines with quality to support regulatory submissions.
  • Produce CDISC-compliant data, either SDTM files or datasets easily programmable into SDTM files.
  • Manage vendors and CROs that perform any data management activities in accordance with contracted scope, costs and timelines.
  • Build effective working relationships with CROs and vendors.
  • May plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
  • Lead, direct, manage, develop, coach and evaluate direct reports, if assigned, and other employees in group in accordance with the Company’s Human Resource policies and plans.
  • Act in accordance with general Company policies, including, for example, the Code of Business Conduct and Ethics.

 Requirements:

  • Four-year college degree preferred, and a minimum 10 years supporting clinical studies, including at least 8 years in a clinical data management role in the biotech/pharmaceutical industry (experience in academic or non-profit organizations may be substituted for a portion of the experience requirements).
  • Experience managing direct reports and overseeing vendors: at least 5 years for Director level or at least 2 years for Associate Director level.
  • A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH, GCP and CDISC.
  • Demonstrated track record in conducting clinical trials in an out-sourced model.
  • Strong behavioral bias towards productivity and being proactive.
  • Excellent interpersonal, communication (oral and written), analytical and organizational skills.
  • Strong influencing and negotiation skills.
  • Proven ability to manage multiple projects and complex timelines in a team environment.
  • Demonstrated leadership capacity in a cross-functional project environment for Director level, or strong evidence of developing such skills for the Associate Director level.
  • Excellent team management skills: ability to lead, train and mentor team members at all levels; experience building teams highly desired.
  • Ability to travel approximately 10% within North America and internationally.

Interested candidates are invited to forward their resume and cover letter to careers@aqxpharma.com, indicating why you feel you are a fit for the Associate Director/Director, Clinical Data Management role at Aquinox Pharmaceuticals, Inc.

We thank all applicants for their interest; only those chosen for an interview will be contacted.