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Associate Director of Preclinical Studies

2 weeks ago

Calgary, Alberta, Canada Fluid Biomed Inc. Full time $120,000 - $180,000 per year

This is a unique opportunity to join an innovative and dynamic team, focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.

The Associate Director of Preclinical Studies will oversee the planning, execution, and reporting of all preclinical testing and research activities, including in vitro, ex vivo, and in vivo studies, in accordance with established Good Laboratory Practices (GLP) and the company's Quality Management System (QMS) requirements. This role will provide guidance on device evaluation protocols as well as input on product development pipelines.

This role will be pivotal in shaping and executing the preclinical strategy to support regulatory submissions (IDE, PMA) and ensure compliance with FDA and international regulatory requirements and standards. The incumbent will work in a fast-paced environment, where taking initiative and collaborating cross-functionally are critical for success. The ideal candidate is a self-directed learner who quickly absorbs and adapts to evolving project needs and delights in overcoming barriers and finding creative solutions to complex problems.

Position Overview

Key Responsibilities

  • Lead the company's preclinical strategy and execution aligned with regulatory and product development goals, including test planning, protocol development, study oversight, and reporting.
  • Overall responsibility for conduct of studies, including design, protocol development, management of amendments / deviations, study execution, data interpretation, analysis, and reporting.
  • Design, manage, and interpret in vivo studies (e.g., GLP-compliant animal studies) to evaluate safety, efficacy, and device performance of the neurovascular stent.
  • Act as primary contact for external and internal GLP and non-GLP preclinical studies (in vivo and in vitro) focused
    on device and accessory performance.
  • Lead and manage direct reports on the preclinical team.
  • Work closely and collaboratively with clinicians, veterinary personnel, external industry/academic providers, Engineering/R&D, and Quality Assurance departments to manage studies from conception to closure, ensuring compliance with ISO requirements.
  • Select, qualify, and manage CROs (Contract Research Organizations) and testing laboratories; ensure studies are conducted on time, within budget, and in compliance with GLP, where applicable.
  • Coordinate and lead the evaluation of biocompatibility under ISO for implantable devices, including protocol development, sample size selection and rationale, interface with providers, and reporting/analysis of results for regulatory submissions.
  • Ensure the selection, availability, preparation of controls/experimental devices, and equipment (including sterilization requirements) are managed effectively for successful study execution.
  • Manage study finances, including sourcing of quotes, PO facilitation, and invoice tracking and routing.
  • Prepare preclinical study and analysis documentation to support early clinical trial applications and study execution.
  • Maintain awareness of relevant test methodologies from peer-reviewed publications and recognized standards.
  • Maintain documentation and preclinical records in accordance with QMS and regulatory expectations.
  • Collaborate with R&D, Regulatory Affairs, and Clinical teams to define test requirements, interpret data, and support IDE/PMA strategy.
  • Author and review preclinical sections of regulatory submissions, including IDE, PMA, technical files, and design dossiers.
  • Support regulatory interactions and audits by representing preclinical data and justifying test strategies and outcomes.
  • Compile, analyze, and present technical data to demonstrate device safety, efficacy, and performance for the Design History File (DHF), Technical Files, and regulatory submissions (ITA, IDE).
  • Support company Risk Management activities via Failure Mode and Effects Analysis (FMEA) for the device and accessories by evaluating risk scenarios and potential mitigations based on study results and published literature.
  • Apply subject matter expertise in toxicology, physiology, biocompatibility, disease and treatment models, and human factors during product development.

Education and Experience Requirements

  • Bachelor's degree in a scientific discipline (e.g., Biomedical Engineering, Biological Sciences, Medical Science) required; M.Sc. or Ph.D. preferred.
  • 7+ years of experience in preclinical testing within the medical device industry; experience with Class III and/or neurovascular devices strongly preferred.
  • Minimum of 2 years serving as a Study Director or equivalent leadership role in life sciences (Biotech, MedTech, Pharma).
  • Demonstrated understanding of GLP requirements; familiarity with GMP and GCP is an asset.
  • Proven track record in designing, planning and executing GLP animal studies and supporting regulatory submissions (IDE, PMA, CE Mark).
  • Strong knowledge of regulatory standards applicable to preclinical testing, including FDA guidance documents, ISO 10993 series, ISO 14971, and OECD GLP principles.
  • Experience with investigational devices and product development life cycles, preferably under PMA pathway.
  • In-depth understanding of FDA regulatory pathways for high-risk/Class III devices.
  • Thorough knowledge of ISO 13485, FDA Class III, and Health Canada Class IV regulatory expectations.
  • Excellent project management and organizational skills.
  • Strong written and verbal communication skills, including experience writing and reviewing regulatory documents.
  • Ability to work collaboratively in a dynamic, fast-paced startup environment.
  • Experience working within CROs is welcomed.

Additional / Preferred Skills

  • Experience working with neurovascular or cardiovascular implants (e.g., stents, flow diverters).
  • Excellent documentation, communication, and interpersonal skills.
  • Ability to adhere to Quality Management Systems and Environmental, Health & Safety (EHS) requirements.
  • Strong prioritization and project management capabilities; PMP certification is an asset.
  • Proficiency in statistical analysis, related software tools, and MS Office Suite.
  • Prior involvement in first-in-human studies and early-phase clinical programs.
  • Familiarity with biostatistics and interpretation of preclinical and clinical data.

Location & Eligibility

This role will be located in
Calgary, AB
, and candidates
must be legally entitled to work full-time in Canada
.