Vice President, Clinical Operations (San Bruno)

About Aquinox:

Aquinox Pharmaceuticals, Inc. (NASDAQ:AQXP) (“Aquinox”), is a clinical-stage pharmaceutical company discovering and developing novel drug candidates to treat inflammation, inflammatory pain, and blood cancers.

Aquinox's lead drug candidate, rosiptor (AQX-1125), is in Phase 3 development for the treatment of patients with interstitial cystitis/bladder pain syndrome (IC/BPS), a debilitating condition marked by chronic pain and urinary symptoms, for which there are currently few FDA approved and/or effective treatment options. Rosiptor has a novel mechanism of action, activating SHIP1 (SH2-containing inositol-5'-phosphatase 1), an enzyme that serves to down-regulate inflammation through its role in the PI3K signaling pathway. Rosiptor has been generally well tolerated in multiple completed clinical studies, with more than 395 subjects dosed.

Aquinox currently has approximately 60 employees in offices in Vancouver, B.C., Canada and San Bruno, CA., USA.  We are a focused team, achieving our goals through our values based culture. Our people are highly results-oriented, proactive and collaborative. 

Top line data from our Leadership 301 trial is expected in Q3, 2018.  If this data is positive, Aquinox will be growing rapidly and adding to all departmental teams.  If you are interested in speaking with us about this role and joining us after our data announcement, please send your cover letter and resume to careers@aqxpharma.com

The Location:

This position may be located in our San Bruno office.

The Opportunity:

Reporting to the Chief Operating Officer and Vice President, R&D Operations, the Vice President, Clinical Operations of Aquinox Pharmaceuticals, Inc. (“Aquinox US”) and its subsidiary, Aquinox Pharmaceuticals (Canada) Inc. (“Aquinox Canada”), together “the Company” provides oversight, planning and timely execution of Clinical Operations for global Phase I to III global clinical trials and post-approval Phase IV trials in accordance with GCP guidelines.

The Vice President, Clinical Operations interacts with external stakeholders, which may include, but is not limited to the Company’s Board of Directors, the FDA and other health authorities, Key Opinion Leaders, Advisory Committees, potential partners, CROs (Clinical Research Organizations) and other contracted service providers and all levels of internal staff.

The Vice President, Clinical Operations leads and manages the Clinical Operations team; may act as sponsor, lead or member of a variety of committees and projects; regularly interacts with most departments in the company, including, but not limited to Clinical Development, Biometrics, Regulatory Affairs, Chemistry, Manufacturing and Control teams, Project Management, and Finance.

This position can be located in San Bruno, CA.

 

Specifically, the Vice President, Clinical Operations will:  

  • Develop and propose Clinical Operations strategies and plans to ensure strong execution and successful, timely completion of global phase I – IV clinical studies conducted through CROs
  • Draft and review CRO Request for Proposals and responses; manage and/or oversee selection process with internal project teams based on pre-determined evaluation criteria
  • Develop collaborative and effective relationships with CROs; use predictive data to define key performance indicators (KPIs) and measure and drive CRO performance in all areas of trial execution – site start-up, patient recruitment activities, data collection, performance against timeline and budget and the like; plan and execute risk mitigation actions if KPIs trend off-track
  • Lead and manage Clinical Operations staff to manage assigned trials in accordance with departmental standards and practices
  • Lead and manage Clinical Operations staff to collaborate with a variety of internal departments and on project teams to prepare for example, study synopses, protocols, case report forms, investigator brochures, investigator meetings, etc.
  • Collaborate with CROs and internal Regulatory and scientific departments to interact with and respond to global and local health regulatory authorities and Independent Review Boa (IRBs), specifically as relates to study approvals and site initiation  
  • Ensure relevant standard operating procedures (SOPs) and related work processes are developed, staff are trained and are competent
  • 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:  

  • Minimum BSc degree, relevant graduate degree highly preferred with a minimum 10-15 years of relevant leadership experience in the biotech/pharmaceutical industry
  • Strong expertise and knowledge of the drug development process is required; end to end Phase III experience from study synopsis to study report highly desirable
  • A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations require, prior regulatory agency liaison experience related to the conduct of clinical trials is essential
  • Strong abstract reasoning and critical thinking skills required; able to thrive in a changing environment, anticipating and planning for multiple scenarios and proactively develop risk mitigation plans
  • Excellent interpersonal, communication, analytical and organizational skills
  • Strong influencing and negotiation skills
  • Capable of managing multiple projects and complex timelines in a team environment
  • Demonstrate leadership capacity in a highly matrix working environment by interacting effectively with internal departments and external organizations
  • Excellent team management skills, ability to lead, train and mentor team members at all levels
  • Ensures effective liaison with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams
  • Ability to travel 15% internationally

Our current clinical trials, exceptional team, and strong track record make it an excellent time to seize this exciting opportunity! We provide a collaborative and innovative environment with competitive incentive packages and rewards. 
We thank all applicants for their interest; however, due to the volume of resumes we receive, only those chosen for an interview will be contacted.