Career Opportunity – Associate Director, Clinical Operations
Aquinox Pharmaceuticals, Inc.(AQXP) is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Aquinox’s lead drug candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Aquinox has successfully completed multiple preclinical studies and clinical trials with AQX-1125 and is advancing through Phase 2 development. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.
Aquinox Pharmaceuticals, Inc. (AQXP) currently has several clinical trials in ongoing; Top line results for two of our trials are expected in the first half of 2015. This is an exciting time to join our team and help contribute to the completion of these clinical trials.
We are looking for an experienced, “hands on,” Associate Director, Clinical Operations to help manage our clinical operations. Reporting to the Senior Director, Clinical Operations,and working in collaboration with our clinical team, the Associate Director, Clinical Operations will be responsible for contributing to, and implementing, the clinical strategy for the company by overseeing the tactical implementation of clinical trial strategies for Phase 1-3 programs. The successful candidate will be working out of our office in Vancouver, BC, and will be responsible for managing CRO’s and third party vendors to ensure the successful initiation and completion of clinical trials and projects.
This is a new and evolving role and can be adjusted to meet the career path and potential of the successful candidate.
- Manages clinical trials/programs to support Aquinox’s development plan.
- Supports the process of designing clinical trials including drafting and amending clinical trial protocols in close collaboration with study physician and other colleagues.
- Accountable for oversight of trials, which includes monitoring data, safety, GCP compliance and timelines for clinical trials/programs.
- Oversees the planning and execution of clinical studies while adhering to budget, resource allocation, scope and schedule requirements.
- Leads study execution teams as needed. Oversees functional deliverables to support program objectives as defined in the Clinical Development Plan.
- Identifies risks, develops risk mitigation plans and escalates
risks and risk mitigation strategies to the Senior Director, Clinical Development.
- Contributes to submissions for regulatory and ethical committee review of clinical trials; Oversees preparation of Informed Consent Forms, advertisements, information leaflets and other material.
- Supports the development of publications.
- Leads the identification and selection of CRO’s for successful clinical trial execution.
- Supports the identification of key opinion leaders in related therapeutic areas and establishes relationships and collaborations as appropriate.
- Organizes data safety monitoring boards and may organize expert panels, consultancy and advisory board meetings to provide input into clinical plans or data analysis.
- Participates as a member of Aquinox project teams, ensuring clinical operational challenges and issues are proactively identified and clearly articulated and communicated.
- Participates in the product development process and defining the clinical application of Aquinox drug development strategy.
- Educates, creates awareness and engages colleagues in the understanding of disease area under investigation.
- Embodies Aquinox’s Core Values and demonstrates these values through everyday actions and behaviors.
- Ensure accurate and timely communications with project teams and management on any issues impacting budgets, timelines, resourcing, or milestones and closely and transparently manages the critical path of projects.
- Prepares weekly project summary reports, reviews action items, facilitates/coordinates meetings and issues meeting minutes, as required.
Qualifications and Work Experience
- 10+ years of experience in pharmaceutical/biotech industry with at least five years of hands-on managerial experience running clinical trials and managing teams remotely.
- Minimum Master’s Degree, in related field preferred.
- Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
- Demonstrated cross-functional clinical project management experience with all aspects of management of large clinical trials from inception to completion.
- Strong researching skills and expertise in searching medical literature and databases for clinical and technical information.
- Strong knowledge of Good Clinical Practice (CGP) as well as local, national and international regulations pertaining to Clinical Development.
- Basic understanding of statistics and statistical methods.
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
- Strong writing skills and ability to effectively communicate verbally and written with technical and non-technical people. Experience developing study protocols and reports is required.
- Demonstrated ability to work in a team environment.
- Strong MS Office skills.
- Ability to travel up to 35% of the time.
Our current clinical trials, exceptional team, and strong track record make it an excellent time to seize this exciting opportunity.
Interested candidates are invited to forward their resume and cover letter to firstname.lastname@example.org, indicating why you feel you are a fit for the Associate Director, Clinical Operations role at Aquinox Pharmaceuticals, Inc.
We thank all applicants for their interest; only those chosen for an interview will be contacted.