Director of Device Development & Combo-Product Strategy

Hemab Therapeutics; København; On-site; DKK 1,200,000 - 1,800,000; Full time

Job summary

Hemab Therapeutics in Copenhagen and the US hub is seeking a Director of Device Development to own the device strategy across programs, integrating drug and device into scalable combination products.

You will lead from development through launch, manage external partners and CDMOs, drive readiness for regulatory approvals in the US and Europe, and build a robust device capability as the pipeline matures.

Qualifications

• Experience leading device or combination‑product development in biotech, pharma or medical devices.
• Experience with biologics and subcutaneous delivery systems (prefilled syringes, autoinjectors, pen injectors).
• Experience managing device development partners, CDMOs and suppliers.
• Experience taking device programs through late‑stage development and manufacturing.
• Strong knowledge of device development controls, human factors and regulatory expectations.

Responsibilities

• Set the device strategy for Hemab globally and per program, including delivery systems.
• Lead external partnerships with CDMOs and suppliers and ensure accountability for delivery.
• Collaborate with Quality and Regulatory to ensure inspection‑readiness for combination products.
• Own device and combination‑product development priorities, timelines and risks.
• Oversee drug‑device interface decisions balancing patient needs and manufacturability.
• Establish ownership between drug and device teams to keep programs moving.
• Lead technology transfer and readiness for launch for combination products.
• Contribute to regulatory work and health‑authority interactions for US and Europe.

Skills

Device development

Combination product

CDMO management

Regulatory strategy

Project management

Stakeholder leadership

Job description

Hemab Therapeutics in Copenhagen and the US hub is seeking a Director of Device Development to own the device strategy across programs, integrating drug and device into scalable combination products.

You will lead from development through launch, manage external partners and CDMOs, drive readiness for regulatory approvals in the US and Europe, and build a robust device capability as the pipeline matures.