Director, Clinical Operations

 

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 Vice President, Clinical Operations, and working out of the San Bruno office, the Director, Clinical Operations directs the planning, execution, monitoring, and completion of any or all of international Phase 1 to 3 and post approval clinical trials.

The Director interacts with Contract Research Organizations (CROs), external physician investigators, other contracted service providers, and all levels of internal staff - acts as the Clinical Operations lead on a variety of cross-functional projects, interacting with team members from a variety of departments, including but not limited to Non-Clinical Development, Clinical Development, Biostatistics and Data Management, Clinical Trial Materials Supply, Regulatory, Quality, Project Management, Finance and Legal. The Director serves as a member of the Clinical Operations senior management team, contributing to departmental polices and SOPs, project and staffing plans and the like.

Specifically, the Director, Clinical Operations will:

  • In collaboration with internal and external scientific and medical experts, plan and execute clinical trials to support clinical development strategies and plans; author, review and/or manage a wide variety of activities, including for example, clinical trial synopses, protocols, case report forms, investigator brochures, and the like; manage internal teams to review and approve clinical study reports in accordance with overall project timelines
  • Prepare Request for Proposal documents and with cross-functional project team, solicit and evaluate bids; lead contracting process with selected CROs, collaborating with relevant departments such as Legal and Finance
  • Manage CROs to execute clinical trials in accordance with contracted scope, costs and timelines; actively engage with CROs on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities
  • Interact with investigators and sites as needed to support CRO and ensure clinical trials are conducted according to plan
  • Identify risks to clinical trial execution success, proactively communicate risks to internal and CRO teams, and bring team together to develop and implement risk mitigation strategies and tactics to enable trials to complete as planned
  • Keep current with clinical development and regulatory changes, technology trends and patient engagement
  • 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 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 and ensure policies are understood and followed by employees in reporting and other departments 

Requirements:

  • BS degree (MSc preferred) and a minimum 12-15 years in a Clinical Operations/Trial leadership role in the biotech/pharmaceutical industry
  • A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
  • 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
  • Excellent team management skills, ability to lead, train and mentor team members at all levels; experience building teams highly desired
  • Ability to travel approximately 15% 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 Director, Clinical Operations role at Aquinox Pharmaceuticals, Inc.

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