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Group Lead Clinical Development (f/m/d) Challenging international leadership role

Our client is a successful pharmaceutical company with its own research and development, operating worldwide. High product quality, the pursuit for innovation and a high level of customer and service orientation are the key indicators for its success.

We are offering the following unique and challenging career opportunity in our office in Vienna throughout regional countries:

Group Lead Clinical Development (f/m/d)

Challenging international leadership role based in Vienna

Your tasks and responsibilities:

  • Strategical planning, designing and project management of clinical development projects (early stage to late stage) in the pharmaceutical field involving medicinal products and/or medical devices
  • Direction and supervision of direct reports with regards to project allocation, training and performance
  • Set-up and development of group structure and processes according to reasonable pharmaceutical, regulatory and GMP as well as GCP and MDR needs and internal requirements (e.g. contracts)
  • Selection and evaluation of CROs and other consultancies as well as ongoing support
  • Compilation of group budget and resource planning, coordination with and approval by line manager
  • Planning and continuous monitoring of the budget
  • Medical writing of trial documents according to GCP and European legislation (e.g. study protocol, Investigator's Brochure, clinical study reports, clinical evaluations, publications etc.)
  • Compilation of technical documentation according to MDR and ISO standards, with focus on clinical development of medical devices (class I - III), including legacy devices as well as new developments (e.g. creation and review of technical documentation, design of user interface, creation of risk assessment, clinical evaluation, PSUR, PMCF)
  • Preparation of responses to questions from health agencies and authorities including dossier update, pre-clinical/clinical responses, additional clinical submission documents, evaluation of available data, response strategy development, comprehensive literature research etc.
  • Close cooperation with KOLs in respective therapeutic areas

Your interesting profile:

  • University degree in Natural Science or Medicine
  • At least 5 years of relevant work experience in the pharmaceutical or medical devices industry in an international environment
  • Experience in pharmaceuticals OR medical device development
  • (First) leadership experience or high leadership potential
  • Strong sense of responsibility, attention to detail, confident, decisive approach
  • Good collaboration, organization and communication skills
  • Pro-active attitude, the ability to develop new concepts and a creative approach to problem-solving
  • Fluent in English

Your benefits:

  • High degree of independence and responsibility for assigned projects and budget
  • Challenging career opportunity for a committed and highly motivated person
  • Fast-growing, modern environment in an internationally operating top company
  • Working in a close-knit, multicultural team with a friendly atmosphere
  • The legal base annual salary for this position is at least EUR 70,000 with a willingness of overpayment depending on your qualifications and relevant experience, additionally performance-based premiums and attractive fringe benefits

You are a target driven, resilient and enthusiastic professional?

Then send us your detailed application documents and insights into your previous track record stating the identification number 91 615 either by email or via our ISG career portal.

ISG Personalmanagement GmbH
A-1010 Wien, Universitätsring 14
Mag. Birgit Prochazka, T: +43 1 512 35 05-16
@:bewerbung.prochazka@isg.com
BEWERBEN

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