Take the lead in ExpreS2ions clinical studies as Clinical Project Manager

Join a growing Danish biotech, and work with early phase clinical studies as a pivotal part of a small central team. In a newly established role as Clinical Project Manager at ExpreS²ion, you will report to Chief Medical Officer (CMO) and be part the of the development project team. ExpreS²ion Biotechnologies ApS has developed a unique technology platform, ExpreS2, for fast and efficient non-clinical development and production of complex proteins for new vaccines, and we are currently expanding and establishing an early phase clinical pipeline. You will be responsible for oversight and conduct of clinical programs, with focus on our therapeutic cancer vaccine (ES2B-C001).

The conduct of clinical studies with ExpreS²ions assets will be outsourced to one or more research organisations (CRO). As Clinical Project Manager at ExpreS²ion your main responsibility will be handling day-to-day study related activities and oversee clinical projects from the operational perspective as well as serving as main point of contact with the CRO(s).

You will coordinate clinical activities with the CRO and together with the CMO be main responsible for overseeing the setup, development and conduct of clinical activities. Together with the CMO you will be in charge of keeping timeline and budget of clinical activities in alignment with internal stakeholders.

Your main tasks are:

  • Collaborate with CMO and rest of in-house project team at ExpreS²ion to ensure successful outcome of clinical activities, with focus on clinical studies, i.e., selection of clinical CROs, ensure sponsors GCP obligations are met, internal alignment around clinical activities and interactions with investigators/KOLs
  • Drive CRO oversight activities during the entire study life cycle
  • Drive clinical project and study management activities in conjunction with study lead(s)/point-of-contact(s) from CRO to ensure:
    • Protocol development
    • Study setup and start-up, and closure
    • Accurate preparation and review of relevant documents
    • CTA/IND submission
    • Enrolment, study oversight/execution, dose escalation and expansion
    • Appropriate tracking of all study documents and maintenance of filing
    • Compliance with ICH/GCP and local regulations
  • Support/oversee CRO e.g.:
    • Submissions and Q&A with CA/IRB/EC(s) etc.
    • Relevant approvals
    • Site budget and contract negotiations
    • Operational aspects of clinical activities (e.g., recruitment and retention, DSMB)
    • Study supplies and equipment, e.g., supply and lab setup
    • Study conduct issues (e.g., protocol deviations, data queries, laboratory discrepancies)

Your qualifications include:

Several years (+5y) of experience from clinical operations, preferably from the biotech part of the pharmaceutical industry and/or from a CRO. Experience must include clinical study management, including overall leadership/accountability, preferably as project lead. Experience with auditing and inspections is preferred.

Experience within the fields of oncology, immunology, vaccinology is an advantage. Thorough understanding of outsourcing to CROs and subcontractors, protocol development, study setup, study management and study closure, and some experience with study monitoring, is required.

You have a Master’s degree in Pharmacy, Biology, Human Biology, or similar scientific education. A PhD is preferred, but not a demand.

You are a person with:

Professional proficiency in English both written and orally. You are proactive and able to work independently to move things ahead, and work structured to high standards. You are a person with the ability to collaborate professionally with both internal and external partners, and communicate project needs and your perspective actively in a small and dynamic setting. You are flexible, open to the challenges of small biotech, and thrive in a dynamic and entrepreneurial research environment.

The team

You will join the ExpreS2ion team located in DTU Science Park/Hørsholm where we are 30 dedicated colleagues ready to welcome you. The entrepreneurial spirit is very much a part of our culture. While we work seriously and result-oriented on reaching our ambitions to grow, we also insist on maintaining a good team culture, developing together, helping each other, and learning new things.

Choosing a position at ExpreS2ion will give you an opportunity to be a part of a company where the expertise of the employees is the driving force – setting the standard high for the future development of the company. We thrive in implementing new ideas, and decisions are made quickly, thus you can have a great influence in your own daily work.

The position refers to the CMO - Mattis F. Ranthe.

Benefits of working at ExpreS2ion

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ExpreS2ion, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only a good level of base pay, but also employee benefits, supportive policies and wellbeing initiatives tailored to support you at all stages of your career - both now, and into the future.

About ExpreS2ion

ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB listed on Nasdaq First North Growth Market Stockholm. ExpreS2ion has developed a unique technology platform, ExpreS2™, for fast and efficient non-clinical development and production of complex proteins for new vaccines and diagnostics. ExpreS2 is regulatorily validated for clinical supply. The platform includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, the Company has produced more than 500 proteins and virus-like particles (VLPs) in collaboration with leading research institutions and companies. ExpreS2ion develops novel VLP based vaccines in association with AdaptVac ApS, of which ExpreS2ion owns 34%. For additional information, please visit www.expres2ionbio.com.

Questions to the position

For more details about the job or the company, please contact Mattis Flyvholm Ranthe mfr@expres2ionbio.com.

Please apply as soon as possible since we will conduct interviews on an ongoing basis.

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