vacature klinisch-onderzoek

Consultant Clinical Development

Derks & Derks

A challenging job within a Dutch Life Science consultancy

Offer
  • a challenging job within a Dutch Life Science consultancy
  • contribute to the development of pharmaceuticals and diagnostics
  • good secondary benefits
Organisation

Our client is a Dutch Life Sciences consultancy and operational support firm, located in Tilburg and Oss. The company is dedicated to the development of pharmaceuticals and diagnostics. Their clients are leading pharma companies as well as innovative biotech start-ups. For the various projects that they are running for their clients, they are looking for a Consultant Clinical Development.

 Position

As a Consultant Clinical Development you will be responsible for the development of clinical strategy and clinical operations of (bio)pharmaceutical compounds. You will be involved in drafting clinical development plans of clinical trials and documentation for regulatory submission.
You are responsible for the clinical development strategy of an investigational compound, including the definition of milestones and Go/NoGo criteria. In this role you need to be able to translate biomarker data to decisive proof-of-concept studies. Besides this you are responsible for the design, execution and reporting of clinical trials according to timelines and within budget, and writing essential documents e.g. Clinical Trial Protocol, IB etc. As a Consultant Clinical Development you are a representative in Scientific Advice meetings at regulatory authorities (EMA, FDA), but also in a cross functional collaborative environment. You are an equal and expert discussion partner in the communication with KOL’s. Other tasks may include managing external partners and/or service providers, guiding operational clinical activities and coordinating project management activities to ensure timely, uniform and quality delivery of the services provided to our clients.

Profile
  • relevant academic background in biomedical field, preferably PhD
  • experience with (early) clinical drug development
  • a minimum of 5 years’ experience in the biotech or pharmaceutical industry
  • evidence of good scientific and clinical judgment, flexibility, and resilience
  • up-to-date knowledge of legislation and regulations and ICH-GCP guidelines
  • experience with Scientific Advice meetings at EMA or FDA is a pre
  • strong sense of meeting milestones, timelines & budgets
  • excellent communication and presentation skills
  • capable of effectively managing multiple deadlines and projects
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-071-DD, to Djamila Hagemans : info@derksenderks.nl.

For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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