Director, Device Development

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

Reporting to: VP, Drug Product & Device Development

About Hemab

Hemab is building preventative treatments for serious, underserved bleeding disorders. These are therapies designed to work with the body's own biology and stop bleeds before they start, instead of treating them after they happen. Our pipeline spans more than one mechanism and modality, because the patients we're built for don't all fit the same one.

We're a patient-first, science-led, clinical-stage company - we went public via our 2026 IPO, and we're scaling across two homes: Cambridge, MA, USA, and Copenhagen, Denmark.

The role

How a medicine is delivered matters. We're looking for someone to take ownership of device development across Hemab's pipeline, bringing drug and device together into combination products that work for patients and can be manufactured reliably at scale.

You'll lead the work from development through launch, while helping us build the device capability Hemab will need as the pipeline matures.

This is both a strategic and hands‑on Director role in the CMC and Manufacturing organization: setting direction, making decisions, managing partners and creating clear ways of working between Drug Product and Device Development.

Relocation: We welcome applications from candidates based outside Denmark and can support relocation. However, candidates must have, or be independently eligible to obtain, the right to work in Denmark without employer sponsorship (as we are not currently able to sponsor a visa or work permit for this role).

What you’ll do

• Set the device strategy for Hemab globally and for each program, making sound choices on delivery systems including prefilled syringes, autoinjectors and pen injectors.
• With a proven track record of working with CDMOs and suppliers, you’ll be comfortable representing Hemab externally - challenging partners when needed and holding them accountable for delivery while maintaining productive working relationships.
• Partner with Quality and Regulatory to make sure device development is inspection‑ready and meets the 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.

What you’ll bring to Hemab

• 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.

Nice to have

• Experience building or scaling a device‑development capability in a smaller biotech environment.
• Rare‑disease, haematology or coagulation experience.

What to expect, honestly

Hemab is still building a lot of its own structure. Systems here tend to get created as we need them, not handed down in advance. Whoever takes this role will likely build some of their own process instead of inheriting a finished one. We work across two hubs and multiple time zones - bridging that well takes real, deliberate effort. And because we’re growing quickly, priorities can shift with less notice than they would at a larger, more established company. You will travel regularly (10-20%), between external partners and our US Hub.

This is the actual shape of working somewhere at this stage: It’s genuinely energising for the right person and genuinely frustrating for the wrong one. If you want a place where the operating manual is already written, this might not be it – but if you want to help write it, this might be exactly it.

Hemab Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Please note: As part of the application process, you will be asked the following question:

"Have you personally held final decision authority over a device or combination-product programme's relationship with an external CDMO (including holding them to account for missed quality or timeline commitments)?"