Medical Director (Clinical Development)

  • Professional
  • Biotech, Pharmaceutical
  • Clinical Operations, Medical, Research & Development
  • Vast (1,0 fte)
  • Innovative Biotech Company

We are looking for a Medical Director (Clinical Development) who can help the company to bring their innovative technology through the clinical development progress and into the hands of healthcare providers and patients.  In this role you are responsible for the Design and Implementation of global clinical development plans for pharmaceutical products in the assigned therapeutic area as well as building the necessary Medical advocacy and consensus externally with top external experts (KOL’s) to support the development & approval of their medical technologies.

Inhoud van de functie

  • Design and execute development plans for the pursued indications in a therapeutic area. 
  • Setup a network of KOL’s in the therapeutic area to discuss, check, validate the clinical development strategy. 
  • Therapeutic area expert by staying up to date on literature, discussions with KOL’s, guidelines and SoC in clinical practice.
  • Identify therapeutic development opportunities.
  • Support Clinical Operations in the execution of the clinical development plan
  • Protocol writing
  • Submission document generation/review
  • Prepare with CHMO and RA submission documents and participate in the discussions with European (SAWP, COMP, CHMP), US-FDA and local authorities on strategy

Functie eisen

  • Medical degree
  • Training in pharmaceutical development
  • Good Clinical Practice
  • Excellent cross functional collaboration skills.
  • Experience of working in the pharmaceutical industry with a track record of delivering clinical and medical success.
  • Minimum of 5 years’ experience in a clinical development organisation (pharmaceutical company and/or CRO) 
  • Designed and executed clinical trials
  • Interactions with regulatory authorities
  • Therapeutic area experience is a must-have requirement.
  • Great communication skills both verbal and written
  • Scientific thinking, data driven
  • Next to English at least one more language
  • Willingness to travel
  • No need to live in the Netherlands

Deel deze vacature

Joan van Droffelaar

Consultant Medical


M (06) 53 662 681

T (035) 543 00 21

Stuur een mail

Trainingen

Reageren op deze functie

Ben je geïntereseerd? Vul dan hieronder je gegevens in en we nemen contact met je op.

Bij aanmelding , accepteert u ons Privacy Statement en geeft u toestemming aan Smelt om u via e-mail op de hoogte te houden.