Medical Pharmaceutical Physician - Medical Affairs (m/f/d)

Our client is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, our client and its subsidiaries have established GMP manufacturing and a robust global supply network of a novel, first-in-class radionuclides and -generator platform for a new generation of targeted cancer diagnostics and therapies. Our clients business
is profitable and growing.
Furthermore, our client is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers such as neuroendocrine cancers or bone metastases. Our client ́s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology.

Medical Pharmaceutical Physician

Scope of Tasks and Responsibilities

  • Medical and scientific leadership for commercial activities, including medical expert engagement, medical information handling, investigator-led clinical studies, support for the commercial launch of new products, particularly Solucin
  • Key role in the design and implementation of the medical and scientific strategies for the clinical development of radiopharmaceutical products, including new indications
  • Responsibility for monitoring the safety of commercialized products and products in clinical development, in partnership with Pharmacovigilance and study CROs. Participation in safety monitoring boards
  • Medical overview of Phase III study in partnership with the study CRO
  • Accountability for clinical sections for regulatory dossiers and medical
    aspects of interactions with regulatory authorities (e.g., participation in
    scientific advice meetings, answering List of Questions)
  • Responsibility for organizing and running advisory boards
  • Active contribution to publications related to clinical data and presentation of results at internal and external symposia
  • Development of close relationships with patient support groups
  • Medical representative of the company, with a high profile both within the
    company and externally.

Profile / Core Competencies

  • Doctor of medicine, preferably with research experience
  • A solid background of clinical experience, including either endocrinology,
    oncology or nuclear medicine
  • At least 5 years experience in industry, with a major focus on medical affairs
    and clinical development
  • Sound knowledge of ICH-GCP and other relevant regulations/guidelines
  • Experience in the preparation of regulatory dossiers and work with
    regulatory authorities
  • Extensive experience in safety and working with Pharmacovigilance
  • Solid background in the development of clinical study protocols and study
    reports
  • Established presentation skills, preparing and giving medical scientific
    presentations to expert audiences
  • Demonstrated expertise in ability to synthesize and communicate medical information clearly
  • Self-confident manner combined with strong communication skills – also fluent in business English
  • Demonstrated leadership skills working in a multidisciplinary matrix setting

What our client offers

  • Interesting and varied role
  • positive workspace with flat hierarchical structures
  • A familiar and open atmosphere in an international corporate culture
  • Flexible working arrangement with attractive compensation package

Interested?

For further information please contact Daniel.Braun@peko-pharm.de via mail or directly: 0049/89/64980106.

Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector

Über PeKo Pharm GmbH

Die Berater der PeKo-Pharm GmbH verfügen durch ihre internationale Projekt- und Managementerfahrung in führenden Unternehmen über ein fundiertes Fachwissen. Durch die langjährige Berufserfahrung und die daraus resultierende  Expertise im Bereich Executive Search in der Lifescience- und Healthcarebranche, erfolgte durch die PeKo- Pharm Gesellschafter der Auf-und Ausbau eines eng verzahnten...
Mehr über PeKo Pharm GmbH