Clinical Development Manager

Clinical Development Manager

Arbetsbeskrivning

Clinical Development Manager
Double Bond Pharmaceutical is looking for Clinical Development Manager to join our team.
You will be responsible for
· Development of clinical documents such as protocol/amendment update, IB update, annual study report, etc;
· Contribute to regulatory activities such as IND, NDA submission, and data cleaning activity;
· Clinical interface for other functions for successful delivery of study;
· Identify and qualify possible clinical trial sites;
· Build relationships to gain market advantage including thought leaders and principal investigators;
· Vendor management – Identify suitable vendors, delegate vendor responsibilities, develop vendor reporting procedures and plan of action.
About you: to succeed in the role of Clinical development manager, we see that you have:
· University or college education of at least 4 years with a scientific focus such as biotechnology, biology, chemistry, biomedicine, or pharmacy
· At least 1-year experience of work experience in the field of clinical trials
· Knowledge of product development in the pharmaceutical industry
· Knowledgeable in science of oncology and able to analyze the data
· Good knowledge of regulatory documentation and requirements
· Ability to work according to GXP and LEAN
· English fluent (Swedish would be a merit)
· Experience with working according to GCP/ICH guidelines;
· Experience in documenting and knowledge of MS Office
· As a person, you work in a structured way, have a strong drive for quality work and demonstrate a considerable degree of autonomy
· You are easy to communicate with while being accurate and analytical. You work just as well independently as in collaboration with others. Furthermore, you are motivated by achieving set goals and are happy to celebrate this together with your colleagues.
To succeed in this position, it is of utmost importance that you are an analytical, structured, and quality-conscious person. You are communicative, confident in yourself and your skills and thus have no problems pursuing issues within the organization in accordance with the internal and external requirements that have been established. Your way of working is permeated by structure and accuracy with a high degree of commitment.
Other information:
Start: ASAP
Scope: full-time
Working hours: office hours
Location: Uppsala (office based)
Salary: By agreement

We recommend that you submit your application immediately as we make an ongoing selection.
Please send your personal letter and CV to Georg Kalbin at georg@doublebp.com

About Double Bond Pharmaceutical (DBP) AB, Uppsala-Sweden:
DBP develops innovative first-in-class approaches for the treatment of cancers, infections, autoimmune diseases, and other life-threatening disorders. Our mission is to provide patients with more efficient and safe products in areas where their needs are unmet.
DBP’s team has international and ambitious young experts in all relevant areas to successfully reach the market.
DBP has a bottom-up organization, allowing for each individual member to contribute significantly to every project. As a small company, we have a close collaboration between all departments, quickly adaptable and reactive to changes.

Sammanfattning

  • Arbetsplats: Double Bond Pharmaceuticals AB Uppsala
  • 1 plats
  • Tills vidare
  • Heltid
  • Fast månads- vecko- eller timlön
  • Publicerat: 14 december 2022
  • Ansök senast: 17 januari 2023

Besöksadress

Virdings Allé 32 B 1TR
Uppsala

Postadress

Virdings Allé 32 B 1TR
Uppsala, 75450

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