Jobs

Head of Clinical Operations

Posted 14 Nov 2024

Employer

RetiSpec

Location

Toronto, Ontario, Canada

Contact

Andre Padure (andre.padure@retispec.com)

Description

RetiSpec is a Toronto-based medical AI company that aims to enable widespread early and accurate detection of neurodegenerative disease markers through a simple eye exam. RetiSpec's AI solutions leverage existing retinal imaging cameras available in most eye clinics to provide real-time results at the point of care—this means that the experience is familiar and comfortable.

RetiSpec's AI solutions are currently available for Research Use Only.

Position Overview

The head of clinical operations will be responsible for overseeing and managing all clinical activities at RetiSpec, including the planning, execution, and oversight of clinical study to support regulatory submissions, new product development, and commercial goals. This role will ensure that all clinical and research initiatives are conducted in accordance with regulatory requirements, quality and ethical standards, and company objectives. The ideal candidate will bring significant expertise in clinical trial management, regulatory compliance, and operational leadership within the medical device industry. The ideal candidate will have experience in start-up/scale-up environments and be aligned with a fast pace of execution.

With new disease-modifying drugs coming to market, the Alzheimer’s landscape is at an important inflection point; making this an exciting and impactful time to be working in this space. This role will have the opportunity to drive positive change to patient health outcomes.

Key Responsibilities

Strategic Leadership:

• Develop and implement clinical and research strategies that align with RetiSpec’s business objectives and support regulatory submissions, including for FDA, Health Canada, and other global regulatory agencies.
• Provide strategic oversight of all clinical affairs and operations, including the planning, budgeting, and execution of clinical trials.
• Partner with the science team to strategically oversee non-dilutive grant funding initiatives, offering high-level direction and feedback on proposals to ensure alignment with RetiSpec’s strategic priorities and maximize funding success.
• Identify and implement cost-saving measures while maintaining high standards of quality in clinical trials.
• Cultivate working relationships with potential partners that promote strategic development.
• Identify high level risks and collaboratively lead resolution of critical issues.
• Implement innovative solutions, best practices and process improvements across the function.

Clinical Trial Management:

• Oversee the design and management of clinical trials, ensuring they are conducted according to regulatory requirements (e.g., GCP), company SOPs, and ethical standards.
• Manage clinical budgets, timelines, and resources to optimize the efficiency of clinical operations.
• Lead site selection, patient recruitment strategies, and clinical monitoring activities to ensure trials are conducted on time and within resourcing and financial budgets.
• Develop risk management plans and implement corrective actions as needed to mitigate any issues affecting the progress of clinical studies.
• Manage clinical budgets, timelines, and resources to optimize the efficiency of clinical operations.
• Identify and implement cost-saving measures while maintaining high standards of quality in clinical trials.

Team Leadership and Development:

• Build, lead, and mentor a high-performing clinical team, fostering a culture of accountability, collaboration, and continuous improvement.
• Provide ongoing training and development opportunities for clinical team members to enhance skills and knowledge in clinical research and trial management.

Regulatory Compliance and Documentation:

• Ensure clinical operations are in compliance with relevant regulations, including FDA, EMA, and Health Canada guidelines.
• Oversee and assist with the preparation and submission of clinical documentation to support regulatory submissions, including clinical study reports and regulatory responses.

Cross-Functional Collaboration

• Collaborate with R&D, regulatory, and quality teams to support product development and regulatory strategy.
• Partner with external vendors, CROs, and clinical trial sites to ensure smooth execution of clinical programs.

Requirements

Advanced degree in health or life sciences (e.g., M.Sc., Ph.D., M.D.), medical, or a related field; preferred.

Minimum of eight-10 years of experience in clinical operations and clinical/medical affairs, with at least five years in a leadership role within the medical device industry, with diagnostic experience preferred.

Extensive and proven knowledge of clinical trial design, management, and regulatory requirements (GCP, FDA, EMA, etc.).

Proven track record of leading successful clinical trials from planning through execution and regulatory submission.

Strong leadership skills with the ability to build and motivate a team.

Excellent organizational, communication, and project management skills.

Experience with Alzheimer’s disease or neurodegenerative diseases is an asset.

Experience in a startup/scale-up is an asset.

Key Competencies

Strategic Vision: Ability to align clinical operations with the company’s strategic goals and navigate complex regulatory environments.

Leadership: Proven skills in leading cross-functional teams and driving organizational change.

Analytical Skills: Strong problem-solving abilities with a data-driven approach to clinical trial management.

Communication: Excellent written and verbal communication skills for reporting to internal teams, regulatory bodies, and external partners.

Why Join RetiSpec?

Be part of a dynamic, innovative company at the forefront of Alzheimer’s diagnostics.

Play a key role in bringing cutting-edge technology to market and making a real impact on patient care.

Work in a collaborative and growth focused environment with opportunities for career advancement.

RetiSpec is committed to fostering an inclusive, barrier-free, and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require any accommodations during the application or interview process, please let us know and we will work with you to meet your needs.