We are looking for a highly motivated and skilled new Clinical Supply Manager (CSM) to join our great team and exciting development journey in Nykode Therapeutics. This is a great opportunity to learn more about product supply management across different projects. The CSM will have the overall responsibility for the IMP and device (PharmaJet) handling in Nykode clinical trials and operationally and functionally manage stakeholders across multiple departments and execute clinical supply in collaboration with CMC, Clinical Team, CROs and CMOs.

Job title: Clinical Supply Manager

Application deadline: Applicants will be reviewed on an ongoing basis

Location: Lyngby, Denmark or Oslo, Norway

The role will report to Head of Development Operations

The key responsibilities of the position include but are not limited to:
• Generate and maintain a supply plan containing anticipation of trial demand and shelf life of products that connects patient recruitment with production, packaging, labelling, storage, training and distribution of IMP and devices (PharmaJet) to ensure that the finished product is where it needs to be, when it is needed.
• Accurate forecasting by anticipating trial demand and aligning supply with enrolment curves to minimize IMP and device waste by logistic accurate shipments to clinical sites from depots.
• Establish and maintain a robust supply chain to clinical sites in collaboration with CMOs, Nykode Trial Teams and CROs.
• IMP reconciliations and destructions from clinical sites.
• Handling of complaints.
• Temperature excursion oversight along the supply chain including deviation and CAPA handling.
• Producing/reviewing/maintaining documents related to Clinical Supply for the purposes of the trials (e.g. Pharmacy Manual).
• Plan and secure drug accountability in Nykode clinical trials through IRT and manual oversight as relevant.
• Handle discrepancies/deviations related to clinical supply to clinical trials.
• Ad-hoc involvement in other activities within clinical operations as needed and as per your preference.

Education, knowledge and experience:
• Excellent English language skills, both oral and written.
• Relevant experience from/or interest in biotech/pharmaceutical Clinical Supply environment.
• Experience with GMP principles and documentation.
• Knowledge of GCP principles as they pertain to clinical supply
• Proven ability to communicate effectively and coordinate with internal and external partners; CDMOs, CMOs, CROs.
• High level of personal initiative and drive.
• High performance and working capacity.
• Ability to adapt quickly to changing circumstances and priorities, maintaining effectiveness and efficiency in a dynamic environment.
• Excellent communication and interpersonal skills, with the ability to work effectively across diverse teams and stimulate a collaborative positive culture.
• Ability to collaborate effectively across diverse teams internally and externally.
• Strong analytical and problem-solving abilities.
• Sound decision-making skills.

Who are we looking for?
When hiring new employees, we look for people inspired by our technology and our quest to unlock the future of medicine. We embrace new ways of thinking and doing. When growing and building our teams, we look for people inspired by our mission and those seeking to join a collaborative and value-based company culture. An eagerness to learn and continuously develop is a core characteristic of our highly skilled and competent individuals. A career at Nykode Therapeutics is an opportunity to take part in the journey to push the boundaries of human advancement. Our work is meaningful and we care about the patients, health care professionals and each other.

Nykode as a company
You will be part of a company where many different nationalities and educational backgrounds try to unlock the future of medicine every day.

We are a leading technology platform that unlocks unlimited possibilities for the future of medicine through our intelligent modular design and tailored hyper targeting.

At present, Nykode is located in two locations - in Oslo, Norway and in Lyngby, Denmark.

As an employee of Nykode, you will meet diversity, lots of skilled and dedicated employees, flexibility and many opportunities to develop your professional skills. If you want to know more about Nykode, the employees and partners, take a closer look at our website http://www.nykode.com.

The application process
We see diversity as a strength and encourage all interested candidates regardless of personal background to apply. Applications will be reviewed on a rolling basis. Apply via the link and please note that we do not accept applications by email.

Should you have any further questions regarding the position, do not hesitate to reach out to: Klas Rådberg, Senior Director, Head of Development Operations (kraadberg@nykode.com).

We are looking forward to receiving your application!