Chief Clinical Research & Development Officer

Employer: Dragonfleye Therapeutics Corp

Position: Chief Clinical Research & Development Officer

Terms of Employment: Full-time / Permanent

Existing Vacancy: This posting is for an existing vacancy.

Location: Toronto, Ontario

Employment Address: 27 Queen Street East, Suite 904, Toronto, ON, M5C 2M6

Hours of Work: 40 hours/week

Language: English

Benefits: Eligible for the company’s health and dental plan, and discretionary bonuses and/or salary increases in accordance with company policy.

Salary: $210,000 CAD / year

Contact: Please send resumes to Recruiting@dragonfleyecorp.com and include “Chief Clinical Research & Development Officer” in the email subject line.

Position Summary:

We are seeking a visionary, data-driven, and highly credentialed Chief Clinical Research & Development Officer to lead and direct our global development strategy, including our clinical and regulatory development. As a key member of the executive leadership team, you will establish strategies to develop treatments through to marketing authorization, implement the appropriate clinical strategy, and design and direct clinical studies to establish benefit and risk, resolve scientific and technological uncertainties, and translate scientific innovation into evidence-based development through sound, state-of-the-art research and data-driven approaches.

The best candidate brings an elite background in ophthalmology, with deep technical expertise in medical devices, drugs, product systems, and combination product research and development, and a strong understanding of the ophthalmology development landscape and the regulatory path to approval. You will be accountable for the design, execution, and interpretation of our clinical programs, while serving as the primary liaison internally to the cofounders, the board, and the technical team, and externally with ethics committees, and with key clinicians, global regulatory bodies, and health authorities as appropriate, including but not limited to the FDA, Health Canada, the EMA (EU), and other appropriate regulatory bodies.

Duties:

Executive (senior) leadership & strategic governance

• Serve as a core member of the leadership team, determining the company’s mission and strategic direction, establishing objectives and policies, and contributing to R&D pipeline prioritization and research strategy, with a primary focus on advancing the scientific and experimental foundation of the company’s programs.
• Define a strategy, allocate material, human and financial resources to each program and reduce that strategy to executable research and development roadmaps, cooperatively with internal stakeholders and external expertise.
• Select middle managers, directors or other executive staff and delegate the necessary authority to them.
• Authorize and organize the establishment of the clinical, regulatory and research functions and associated senior staff positions, and establish financial and administrative controls over research and development spending.
• Present clear, data-driven clinical and regulatory updates, including risk-management summaries, to the cofounders and board of directors.
• Represent the organization in negotiations and other official functions, and establish and maintain high-impact relationships with global ophthalmology key opinion leaders, and scientific and clinical advisory boards to review clinical protocols and inform research direction.

Experimental design, clinical development & internal cross-functional research

• Collaborate with and contribute to engineering, research, and manufacturing teams in providing input, reviewing data and output, and providing subject matter expertise.
• Design and direct systematic experimental investigations intended to resolve scientific and technological uncertainties relating to ophthalmic drug delivery systems, device configurations, treatment protocols, dosing strategies, and preclinical/clinical performance of ocular product treatment systems and drug delivery devices (injectors).
• Formulate testable hypotheses, define experimental objectives, select appropriate experimental methods and models, establish evaluation criteria, and assess alternative approaches where initial results do not achieve the intended technical outcome.
• Apply regulatory strategies to inform study design, risk assessment, endpoint selection, evidence requirements, and development pathways; design cutting-edge study protocols and proactively assess alternative approaches or contingencies where initial designs do not achieve the desired technical outcomes.
• Design and oversee robust, innovative clinical research and development plans (CDPs) for ophthalmic medical devices and combination products from First-in-Human (FIH)/Feasibility through Phase 3/Pivotal trials.
• Champion advanced biostatistical methodologies, sample size calculations, and endpoint strategies to maximize clinical trial power and efficiency.

Data interrogation, troubleshooting & iteration

• Analyze, interpret, and troubleshoot preclinical and clinical data to determine whether experimental objectives were achieved and to guide subsequent design, protocol, dosing, or device-system iterations.
• Directly iterate study designs and interface with the technical lead for device system configurations based on results obtained to ensure continuous optimization of the products and the pipeline.
• Contribute to the advancement and optimization of proprietary delivery systems through continuous experimental refinement and data‑driven improvements.

External partner and vendor management & technical direction

• Interface with, manage, and direct research and development efforts with an external partner organization working together toward a product with multiple components, including those from the partner.
• Provide hands‑on technical direction to Contract Research Organizations (CROs), retaining ultimate internal responsibility for experimental design, technical decision‑making, and the interpretation of outcomes.
• Ensure deliverables from external partners and from CROs align precisely with company data integrity standards, timelines, and clinical-regulatory milestones.
• Maintain and/or oversee contemporaneous technical documentation supporting the R&D process, including hypotheses, protocols, results, failures, design decisions, technical rationale, and time allocation by project.
• Coordinate with Canadian internal technical personnel, external research partners, CROs, and clinical collaborators to ensure experimental work is properly designed, executed, documented, and linked to Dragonfleye’s R&D objectives.

Regulatory Strategy & Agency Interfacing

• Bring in external expertise where needed, and define and execute the global regulatory roadmap, including IDE, 510(k), PMA for device systems, and IND, and NDA/BLA pathways for combination products.
• Serve as the primary strategic research and development face of the company during formal interactions with the FDA, EMA, and international regulatory authorities and health authorities.
• Oversee and contribute to the compilation and submission of high-quality regulatory science dossiers, ensuring strict compliance with evolving product guidelines.

Translational & Nonclinical Integration

• Provide strategic, scientific, and medical oversight to the translational and nonclinical teams, ensuring that bench-top, in vitro, and in vivo safety/efficacy research data seamlessly inform clinical trial designs.
• Evaluate pharmacokinetic (PK), pharmacodynamic (PD), and biocompatibility data to define and refine minimally viable product (MVP), target product profile (TPP), and dosing strategies.

Requirements:

• PhD, MD/PhD, or equivalent advanced medical/scientific degree with a specialization or experience in ophthalmology or with a substantial, demonstrable clinical dedication to ocular science, research, and medicine is required
• 5 – 10 years of progressive leadership experience within the biopharmaceutical, medical device, or combination product industries is required
• Proven track record of driving drugs, combination products, or medical devices through complex clinical research and development pathways.
• Expertise with designing and executing clinical programs and clinical studies in drugs, medical devices, or in combination products.
• Knowledge of and track record of incorporating regulatory input into clinical study design and execution to ensure appropriate outcomes are realized for patient benefit.
• Direct experience managing formal interactions and negotiations with the FDA and other major global regulatory bodies to represent science, research, and development for the company
• A successful track record of contributing meaningfully to or securing product clearances or approvals (PMA, 510(k), NDA, or BLA)
• Deep, intrinsic understanding of the unique challenges associated with ophthalmology, with clinical and regulatory science and strategy, and with ophthalmic drug delivery systems, including specialized surgical delivery and sustained-release platforms.
• Exceptional research-data literacy; ability to analyze raw clinical data, interpret information, interrogate statistical models, and translate findings into actionable corporate strategy.
• Outstanding communication and executive presence, with an ability to command the respect of clinicians, regulators, and board members alike.
• Thorough knowledge of GCP, ICH, and ISO guidelines, and global quality/compliance structures for medical products and for combination medicines.

AI Disclosure: We may use artificial intelligence tools to assist with scheduling interviews and managing screening times. We do not use AI to evaluate applicants or make decisions during the interview process. All candidate assessments and hiring decisions are made by our recruitment and leadership teams.