Clinical Operations Director / Senior Clinical Project Manager

Hubro Therapeutics

Hubro Therapeutics AS is a clinical stage private Norwegian biotech company founded in 2018 and located in Oslo. Our focus is on development of novel proprietary anti-cancer vaccines. We believe that cancer vaccines will play important roles for the further improvement of immunotherapy of cancer. It is our desire and sincere hope to improve the lives of cancer patients. Our lead candidate peptide vaccine in clinical development is FMPV-1. FMPV-1 targets frameshift mutation in the transforming growth factor β receptor 2 (TGFβR2) gene, frequently present in MSI-colorectal, stomach cancer as well as in hereditary colorectal cancer. Additionally, there are two further products currently in early development targeting other MSI-H cancers. More info at www.hubrotherapeutics.com

Clinical Operations Director /
Senior Clinical Project Manager

Come and join one of the most exciting, dynamic, and fast-growing peptide vaccine biotech companies in Norway!

Hubro Therapeutics is currently seeking Senior ClinOps candidates who will take an active role in setting up the project management function in the company as well as the further development of our products.

The positions offer an opportunity to work with a competent and dedicated Hubro team developing novel cancer vaccine treatments. You will have varied and challenging responsibilities in an innovative and dynamic work environment. You will oversee key aspects of Hubro’s clinical development programmes.

 

Main Responsibilities:

  • Detailed knowledge of project management systems and set up of project systems.
  • Contribution to the clinical development plan and study specific study management plans for Hubro products.
  • Oversight of execution of assigned studies from conception through study closure and final inspection preparation: managing external vendors and monitoring teams
  • Participation in the development and review of study documents (i.e. protocol, ICF template, plans, manuals, site recruitment materials, CSRs, etc.). Liaison with regulatory groups for Agency submissions.
  • Responsibility for Trial Master File activities.
  • Collaboration with internal and external stakeholders to ensure alignment of responsibilities.
  • Developing and maintaining study timelines, budget and ensure study is appropriately resourced.
  • Ensuring study specific decisions, actions, issues and risks information is documented throughout the lifecycle of the study.
  • Conducting quality oversight and site engagement visits.

 

Skills & Competencies:

  • Academic degree in life sciences
  • Extensive clinical research and project management experience
  • Deep knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e.
  • ICH GCP and relevant local laws, regulations and guidelines.
  • Broad oncology therapeutic knowledge desired.
  • Leadership skills with ability to work with others to deliver results to the appropriate quality and timelines, monitoring/managing performance and providing feedback

Additional info:

We can offer varied and exciting work in an innovative and dynamic biotech company. We promise you will develop professionally with challenging tasks in a growing company, as you participate in the development of novel cancer treatment.
The positions will be located at Hubro Therapeutics main offices at Oslo Cancer Cluster incubator in Oslo, Norway. International travel can be expected. English is our working language.

 

Contact information:

The recruitment process is carried out in collaboration with the consulting company Borka Consulting AS.
If you have any questions regarding Hubro Therapeutics or the position, feel free to contact our recruitment advisor in Borka Consulting; Cecilie Fraas Borka at +47 928 55 352 or email to cecilie@borka.no
Please send your application (both motivational letter and CV in PDF format) to cecilie@borka.no
All inquiries are treated confidentially, also towards Hubro Therapeutics in the initial phase if desired.
We look forward to receiving your application!
Borka Consulting is a specialised search & recruitment company that has 100% focus on competence-based search and recruitment in the Life Sciences sector.

For å søke på denne stillingen må du sende en e-post med CV og søknadsbrev til andre@borka.no

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