Director, Clinical Operations

TITLE

Director Clinical Operations

TERMS OF EMPLOYMENT

This is a full-time position (1.0 FTE)

COMPANY PROFILE

Qu Biologics is a private, Phase 2 clinical-stage biopharmaceutical company located in Burnaby, BC developing Site Specific Immunomodulators (SSIs), a novel immunotherapy platform designed to restore normal immune function to reverse the immune dysregulation underlying many conditions including cancer and chronic inflammatory diseases. 

IS QU FOR YOU?

Do you love doing something that you can feel passionate about? Are you excited by innovation, new ideas, and working with a creative, fun, and inspired team? Then, this is for you! We’d love to hear from you if:

• 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 real-world problems

• You value respectful, open communication and inspired teamwork to achieve shared goals

• You always ask “Why?”

POSITION DESCRIPTION

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 clinical trials are fully supported. 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):

• Manage clinical trial implementation, including managing clinical sites, external consultants, and CROs to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements.

• Determine resource needs for implementation of clinical operational plans and timelines

• 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.

• Lead and contribute to the creation of high quality clinical trial applications, clinical study reports, investigator brochures, clinical protocols, publications, and presentations of clinical study results.

• 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.

• Prepare, coordinate, and maintain clinical sections for regulatory submissions.

• 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

• 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

REQUIRED QUALIFICATIONS

• Minimum Bachelor of Science degree or equivalent and at least 10 years pharmaceutical industry experience specifically in clinical drug development. Position also requires at least 5 years of experience managing the clinical operation function. Experience participating in international clinical studies is an asset.

• A higher degree (i.e., MSc, PhD, PharmD, MPH, MBA, etc.) is preferred.

• Therapeutic area experience in oncology, infectious disease, metabolic disease, and biologics is desirable.

• Experience working in a small biotech setting is desirable.

• Extensive knowledge of Health Canada, FDA, and ICH guidelines and regulations governing conduct of clinical studies, design of clinical protocols, creation of investigator brochures and other materials.

• Experience in ethics submissions to local and independent research ethics committees preferred.

• Experience in clinical trial recruitment for a variety of patient populations and study designs.

• Experience leading successful CTA submissions to Health Canada and other regulatory agencies.

• Excellent verbal and written communication and presentation skills.

• 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 an asset.

• Willingness to travel as necessary, consistent with study needs.

• Exceptional level of self-responsibility and accountability are essential.

LANGUAGE REQUIREMENTS

Fluent English

DESIRED START DATE

ASAP. The position is open so please apply!

COMPENSATION

Salary and vacation commensurate with experience.

COMPANY & LOCATION OF WORK

Qu Biologics Inc.

4475 Wayburne Drive, Suite 305

Burnaby, British Columbia

V5G 4X4 Canada

HOW TO APPLY

Please visit https://www.qubiologics.com/ for more information about Qu Biologics.

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.