Clinical Operations Director / Aurealis Oy Finland

Aurealis Therapeutics AG / Aurealis Oy is a Swiss-Finnish private biopharmaceutical company focusing on development of the clinical asset AUP-16, the first-in-class, four-in-one biologic drug for chronic wounds and other chronic inflammatory and regenerative diseases.

We at Aurealis Oy are looking for an experienced Clinical Operations Director for a permanent-term contract in Kuopio or other location in Finland. The start date of the job is negotiable but there is a possibility to commence on short notice. You will be working fulltime.

Read more about us: https://aurealistherapeutics.com/about/

We are looking for a goal oriented and determined team player with strong leadership skills for leading the international clinical operations of the company. As the Clinical Operations Director, you are responsible for leading, designing, executing, reporting, and analyzing clinical trials. Your previous work experience and knowledge defines your position and responsibilities, so you have the opportunity to affect your role. Successful candidate for this role must be able to communicate in English.

We hope that you have at least +5 years of experience in similar roles and in depth, hands-on experience and understanding of clinical trial design, execution, and follow-up (including the regulatory requirements). You have a preferred education e.g., Master’s or Doctoral degree in Medical Science, Pharmacy or Biochemistry, or other educational background that is suitable for the position. You will be closely working with our clinical and regulatory team, and with external service providers. You are collaborative, highly organized and enjoy working with different systems. If so, you might be our new colleague!

Experience and skills required:

  • Overall knowledge and experience of the drug development process, clinical trial conduct, data management and drug safety and biostatistics
  • Deep knowledge of relevant regulations e.g. ICH/GCP/GVP, EMA and FDA guidelines
  • Excellent organizational, decision making and project management skills
  • Study finance management experience (CMOs, CROs and other vendors)
  • Study site and people management and facilitation experience
  • Experience in working with software programs (EDC, eTMF etc.)

We will offer you a position in an international and dynamic working environment where you have the opportunity to develop your career path. Join our team!

If you are interested in the position, please submit your application as soon as possible as we will be interviewing during the application time.

If you have any questions regarding the position, please contact Jani Huttunen puh. 050 307 9337, jani.huttunen@ohp.fi

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Employment type: Permanent-term contract

Aurealis Therapeutics

Aurealis Therapeutics AG / Aurealis Oy is a Swiss-Finnish biopharmaceutical company developing a broadly applicable technology platform facilitating protein/antibody combination therapy embedded in one single product that can be administered in a safe, efficient and cost-effective way. Safe food-grade lactic acid bacteria produce and secrete multiple therapeutic human proteins locally in target tissue. Our first products are immuno-therapeutics targeting chronic inflammatory wounds and cancer. Our lead development candidate AUP1602-C is ready to move forward into first-in-human phase 1-2A study and the preparation and set up of this study will be the focus for the engagement with Aurealis Therapeutics AG.

Location: Microkatu 1, Kuopio
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