Director, Clinical Administration & Compliance

Pharmacosmos; Holbæk; On-site; DKK 1,400,000 - 2,100,000; Full time

Job summary

Pharmacosmos invites a hands-on, senior leader to establish and head a new Clinical Administration & Compliance function. You will combine people leadership with direct involvement in clinical trial administration, processes and operational GCP compliance.

As Director, you will lead TMF quality, sponsor oversight and inspection readiness, shaping risk-based, pragmatic workflows and robust documentation practices across R&D.

Qualifications

• Experience leading clinical operations
• Strong knowledge of ICH-GCP and regulatory expectations
• Hands-on with trial processes, SOPs and essential documentation

Responsibilities

• Lead the new Clinical Administration & Compliance function
• Translate regulatory requirements into practical workflows
• Ensure inspection readiness and sponsor oversight across R&D trials
• Drive continuous improvement in processes and documentation practices

Skills

Leadership

ICH-GCP knowledge

TMF & documentation

Regulatory compliance

Job description

Director, Clinical Administration & Compliance

Join Pharmacosmos in a newly established function, in a role combining people leadership with direct involvement in clinical processes, compliance and continuous improvement.

Build and lead a new Clinical Administration & Compliance function
As Director, Clinical Administration & Compliance, you will report directly to the Senior Director, Head of Clinical Operations, Trine Kolding, and take on a key role combining leadership with hands‑on responsibility for clinical trial administration, processes and operational GCP compliance.

You will lead and develop the Clinical Administration and Process Management functions, setting clear priorities and direction while fostering collaboration, accountability and high‑quality delivery. At the same time, you will remain actively involved in developing, implementing and continuously improving processes that support effective and compliant clinical trial execution across R&D.

A key responsibility will be to translate ICH‑GCP, regulatory expectations and internal requirements into practical, risk‑based ways of working. You will contribute directly to operational compliance, documentation practices, TMF quality, sponsor oversight and inspection readiness, ensuring that processes are robust, pragmatic and consistently applied. Working closely with trial teams and stakeholders across R&D, you will identify opportunities to simplify and strengthen processes and drive improvements through implementation.

A hands‑on leader who enjoys making compliance work in practice
The ideal candidate brings extensive experience from clinical research or clinical development within the pharmaceutical, biotechnology or CRO environment, combined with strong practical knowledge of ICH‑GCP and the processes and documentation required to execute and oversee clinical trials. You have hands‑on experience with clinical trial processes, SOP implementation, TMF and essential documentation, as well as inspection readiness.

You have gained leadership experience, ideally within Clinical Operations, Clinical Process Management or a related area, while remaining motivated by direct involvement in the work. Experience working across functions and navigating multiple stakeholders within an R&D and trial‑execution environment is essential.

You genuinely enjoy working with clinical processes, compliance and continuous improvement and are motivated by a role that combines leadership with hands‑on responsibility. You bring a pragmatic and risk‑based mindset, enabling you to translate regulatory requirements into practical ways of working while balancing compliance, simplicity and effective trial delivery.

As a person, you are structured, collaborative and confident in engaging stakeholders across Clinical Operations and the wider R&D organization. You are comfortable setting direction and priorities while staying close to the details, and you have the judgement and drive to identify areas for improvement and turn them into sustainable ways of working. You communicate clearly at all levels and have the natural authority to engage and motivate people. You are fluentinDanish andEnglish,bothwritten and spoken.

Join a highly collaborative Clinical Operations team
You will join a highly collaborative Clinical Operations environment built on trust, ownership and strong collegial relationships. We learn from each other, share responsibility and solve new challenges together rather than working in silos.

As Pharmacosmos continues to grow, you will have a genuine opportunity to shape how we work as the organization develops and make a visible contribution to both Clinical Operations and the wider R&D organization.

Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood‑related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 650 specialists across the UK, Ireland, the Nordics, Germany, Canada, and the USA. Learn more about Pharmacosmos at www.pharmacosmos.com .