Clinical Project Manager


Mehr Jobs von Panoptes Pharma GmbH
Kontakt: Dr. Stefan Sperl
Email: info@panoptes-pharma.com

Panoptes Pharma is a clinical stage biotech company focused on developing small molecule based therapies for the treatment of severe eye diseases with high unmet medical need. Panoptes’ development program focuses on a new treatment for orphan autoimmune uveitis, a disease which is one of the major causes of blindness. For this indication, PP-001 is developed as long-acting intravitreal injectable. Further indications in Panoptes’ focus are dry eye disease and adenoviral conjunctivitis to be treated with eye drops.

To increase our development team, we are hiring an experienced Clinical Project Manager.

Roles and Responsibilities

  • Plan, manage, and oversee clinical phase 1 and 2 studies through their whole life cycle
  • Contribute to study protocols, and other study relevant documents like IBs, CSRs and take responsibility of trial specific ones (i.e. ICF)
  • Management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution.
  • Take final responsibility for TMF and inspection readiness
  • Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans).
  • Assist in preparation of regulatory filings (e.g. CTA, IND, pre-IND, orphan applications etc.) as needed.
  • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
  • Actively participate in clinical Investigator meetings, study meetings, and vendor meetings as needed.

Experience, Education and Specialized Knowledge and Skills

  • Study degree in life science preferred
  • Min 3 years of experience as Clinical Project Manager in Pharma, Biotech or CRO
  • Extensive experience managing early phase clinical studies required.
  • Experience monitoring clinical studies.
  • Management of CROs, multiple vendors, and complex protocols.
  • Experience in ophthalmology preferred
  • Ability and willingness to travel as needed.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually within a multi-disciplinary team, as well as with external partners and vendors.
  • Strong communicational skills including fluency in written and spoken English and German

Panoptes offers flexible working time, competitive salary, and the possibility to participate in Panoptes’ future success. Panoptes’ offices are located close to Vienna’s beautiful city center, with excellent connection to public transport. The minimum salary for this position according to the Kollektivvertrag is 42.117€ per year (fulltime). Overpayment is possible.

If you enjoy working in a small team, having a broad area of responsibility and the willingness to participate significantly in all areas of developing new drugs, we are happy to receive your job application and CV via email to:

Panoptes Pharma Ges.m.b.H

Attn.: Dr. Stefan Sperl, COO

Mail: Info@Panoptes-Pharma.com

Reisnerstrasse 34/1

1030 Wien

Austria

 


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