Senior Director, Technical Development Lead, Device in Toronto

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases. Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.

Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies. We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.

BlueRock Therapeutics LP is a clinical stage cell therapy company harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

This role is responsible for providing strategic and technical leadership for the development and execution of potential delivery device systems supporting the company’s combination cell therapy portfolio. In addition, this role serves as the single point of accountability for program-level technical development, ensuring alignment from early development through clinical stages and commercialization readiness. The individual will bring deep expertise in medical device development and commercialization, integrated with biologics/cell therapy development, to enable successful delivery of complex combination products. This leader will work cross-functionally with Device Development, Clinical Development, Regulatory Affairs, Quality, and External Manufacturing teams to ensure device solutions are robust, scalable, regulatory-compliant, and aligned with patient, clinician, and business needs.

Responsibilities:

• Strategy & Leadership: Define and lead the medical device development strategy aligned with the company’s cell therapy pipeline and long-term platform vision. Act as a core leader for combination product development, ensuring strategic alignment across various technical areas. Serve as the primary technical leader in governance forums. Act as a thought leader in device-enabled cell therapy delivery, monitoring emerging technologies, standards, and competitive approaches.
• Produce Development Oversight: Lead integration of device options into an overall program strategy. In partnership with functional leadership, oversee device development activities including but not restricted to: user needs, design inputs/outputs, risk management, verification & validation, and design transfer. Ensure device designs are compatible with sterile, GMP, and scalable manufacturing environments while meeting international or region-specific standards.
• Program Leadership: Drive integrated development plans and timelines ensuring execution across a matrixed organization. Partner with Regulatory Affairs to define and execute U.S. and global regulatory strategies for combination products (e.g., FDA CDRH/CBER interactions). Support regulatory submissions including IND-enabling device sections, IDEs, 510(k), PMA, De Novo, and combination product filings as applicable. Partner with various stakeholders to ensure devices meet real-world clinical workflows and adoption requirements. Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, and applicable combination product regulations.

Minimum Requirements:

• Advanced degree (MS, Ph.D., or equivalent) in Biomedical Engineering, Mechanical Engineering, Materials Science, or related discipline.
• 12+ years of progressive experience in medical device development, with senior leadership experience in biotech, medtech, or combination product environments.
• Demonstrated success leading complex device programs from concept through commercialization.
• Hands-on experience with combination products, drug-device or biologic-device integrations strongly preferred.
• Deep knowledge of medical device regulatory frameworks and design control requirements.
• Track record of building and leading high-impact technical teams.
• Experience managing external development partners, CDMOs, and device vendors.
• Strategic thinker with strong execution discipline.
• Collaborative, strategic leader who thrives in cross-functional matrix organizations.
• Clear communicator with the ability to influence at executive and board levels.

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.