If this opportunity matches your character, experience and skill set, please email a cover letter and resume in PDF format, to firstname.lastname@example.org with the job code: “VP of Clinical Operations” in the header.
Applications will not be accepted by fax, mail, or over the phone. While we thank all applicants for their interest, only short-listed candidates will be contacted. Please note that we will not be fielding inquires by phone.
Vice President, Clinical Operations
TERMS OF EMPLOYMENT
This is a full-time position (1.0 FTE)
Qu Biologics is a private, Phase 2 clinical-stage biopharmaceutical company located in Vancouver, BC, developing a transformative immunotherapy platform, Site Specific Immunomodulators (SSIs), designed to restore normal immune function to reverse the chronic inflammation underlying many conditions including cancer and chronic inflammatory diseases.
IS QU FOR YOU?
Love doing something that you can feel passionate about? Excited by innovation? Love new ideas and working with a creative, fun and inspired team? Want to make a difference in the world and work with people who feel the same? Then this is for you!
• You are well-organized, understand the importance of detail, and can multi-task and prioritize duties effectively
• You understand the importance of identifying and overcoming rate-limiting steps to ensure that projects are moving forward as quickly as possible, without sacrificing quality
• You are innovative, practical, and enjoy finding the most efficient and cost-effective solutions to realworld problems
• You value respectful, open communication and inspired teamwork to achieve shared goals
• You always ask “Why?”
This job posting is for a full-time (1.0 FTE) position. The successful candidate must be a results-oriented “do-er” who is happy to roll up their sleeves and do whatever it takes to get the job done. Excellent organizational and time management skills, self-responsibility and accountability, and ability to interact positively with other team members are absolutely required. This position requires a proven ability to multi-task efficiently and to ensure that Qu’s SSI immunotherapy platform is fully supported with respect to developing and implementing the strategies required to successfully execute Qu Biologic’s clinical studies. The candidate will work as part of a growing team in a very busy biopharmaceutical company environment. You will report directly to the CEO. Specific duties and responsibilities will include (but not limited to):
- Lead clinical operations strategic planning activities. Translate strategic decisions into actionable operational plans and budgets and ensure the efficient and effective implementation of the plans in a highly accountable manner consistent with plan/budget timeline.
- Determine resource needs for implementation of clinical operational plans and timelines Work with other department heads to determine/meet overall product development plans and company strategy/objectives
- Provide strategic planning and feasibility analysis for site selection, contract negotiations and patient recruitment programs. p. 2/3
- Manage clinical trial implementation with clinical sites, external consultants and CRO personnel to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements.
- Recruit and interact with investigators as warranted to ensure the efficient and effective implementation of clinical operational plans, including obtaining necessary documentation and information before, during and after the study.
- Prepare and present at investigator meetings to ensure that the clinical and investigational site staff team is well informed about the study and related procedures.
- With CRO partner, manage investigator recruitment activities including identification and contacting of potential investigators; conduct pre-study site visits to assess the willingness and suitability of potential clinical sites.
- Manage the maintenance of regulatory documentation from clinical sites and investigators required for the initiation and continuation of clinical studies; manage patient accrual, screening, and enrollment information from sites.
- Oversee the operational selection of vendors, including review of proposal requests.
- Work with various in-house functional group leads and external advisors with regards to clinical study operational issues including safety reporting and processing, study drug supply plans, cross-functional communication/interaction plan and monitoring.
- Manage progress of clinical studies and ensure adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and reviewing and acting on trending reports.
- Develop and manage clinical trial budgets; proactively provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner.
- Generate high quality clinical trial applications, clinical study reports, investigator brochures, clinical protocols, publications, and presentations of clinical study results.
- Prepare, coordinate, and maintain clinical sections for regulatory submissions.
- Minimum Bachelor of Science degree or equivalent and at least 15 years pharmaceutical industry experience specifically in human drug development. Position also requires at least 10 years of experience in the clinical development & management of clinical operation function. Experience participating in international clinical studies preferred.
- A higher degree (i.e., MSc, PhD, PharmD, MPH, MBA, etc.) is preferred.
- Therapeutic area experience in oncology, infectious disease, and biologics is desirable.
- Experience working in a small start-up setting is desirable.
- Extensive knowledge of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
- Experience leading successful CTA submissions to Health Canada and other regulatory agencies.
- Excellent verbal and written communication and presentation skills. p. 3/3
- Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team, provide mentorship to team members and to effectively manage multiple vendors. Ability to efficiently manage direct and indirect reports including remote staff.
- Adaptable, flexible, independent, and resourceful with a roll-up-sleeves mindset to multi-task and thrive in small company environment.
- Ability to proactively identify challenges, possess strategic foresight and implement appropriate courses of action.
- Proven track record of successfully delivering projects on time, to budget and at the required quality.
- Successful track record in managing Phase I and, Phase II global clinical trials. Experience leading pivotal studies is a plus.
- Willingness to travel as necessary, consistent with study needs.
- Exceptional level of self-responsibility and accountability are essential.
DESIRED START DATE
ASAP. The position is open so please apply!
Salary commensurate with experience. Three (3) weeks annual vacation prorated as applicable.
COMPANY & LOCATION OF WORK
Qu Biologics Inc. 4475 Wayburne Drive, Suite 305 Burnaby, British Columbia V5G 4X4 Canada