Director, Global Device & Combo-Product Development

Blonde Inc.; København; Hybrid; DKK 1,000,000 - 1,600,000; Full time

Job summary

Hemab is seeking a Director of Device Development to own and advance the integration of drug-device combination products across the pipeline. You will guide strategy, oversee external partners, and drive manufacturing readiness from development through launch, with a focus on quality, risk management, and regulatory expectations in a global, dynamic environment.

You will coordinate closely with Drug Product and Formulation, balance patient needs with manufacturability, and build a capable device

Qualifications

• Experience leading device or combination-product development in biotech, pharma or medical devices, with enough depth to own a program rather than simply contribute to one.
• Experience with biologics and subcutaneous delivery systems such as prefilled syringes, autoinjectors or pen injectors.
• Experience managing device-development partners, CDMOs and suppliers.
• Experience developing combination products and making decisions across the drug-device interface.
• Experience taking device programs through later-stage development, scale-up and manufacturing.
• Strong working knowledge of device development controls, human factors, risk management and the regulatory expectations for combination products.
• The ability to set direction, run complex programs and keep internal teams and external partners moving towards the same outcome, in a technical, multicultural global working environment. Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration,resilience, leading by example.
• A practical approach to building capability: you can create the structure a growing company needs without importing layers that slow the work down.

Responsibilities

• Set the device strategy for Hemab globally and for each program, making sound choices on delivery systems including prefilled syringes, autoinjectors and pen injectors.
• Represent Hemab externally with CDMOs and suppliers, challenging partners when needed and holding them accountable for delivery while maintaining productive working relationships.
• Partner with Quality and Regulatory to ensure device development is inspection-ready and meets requirements for combination products as programs move towards approval and launch.
• Lead device and combination-product development across the pipeline, with ownership of priorities, timelines, risks and delivery.
• Work closely with Drug Product and Formulation to make good decisions at the drug-device interface, balancing patient needs, product characteristics, manufacturability and development risk.
• Establish clear ownership between drug and device teams so decisions are made at the right level and programs keep moving.
• Select and lead external device-development partners, CDMOs and suppliers, holding them accountable for quality, timing, budget and outcomes.
• Take combination products from development into scalable, robust and cost-effective manufacturing, including technology transfer and readiness for launch.
• Own the device-development framework, including design controls, risk management, human factors, verification and validation, without creating structure for structure's sake.
• Lead activities for Device Development in regulatory work and health-authority interactions, bringing the judgement needed to meet combination-product requirements in the US and Europe.

Job description

Hemab is seeking a Director of Device Development to own and advance the integration of drug-device combination products across the pipeline. You will guide strategy, oversee external partners, and drive manufacturing readiness from development through launch, with a focus on quality, risk management, and regulatory expectations in a global, dynamic environment.

You will coordinate closely with Drug Product and Formulation, balance patient needs with manufacturability, and build a capable device