Medical Doctor for Onkology (m/f) as Senior Project Manager for the Clinical Research Department

A. Menarini Research & Business Service GmbH in Berlin is a German subsidiary of the global MENARINI Group based in Florence, Italy. The pharmaceutical company provides specialised services for BERLIN-CHEMI AG and other companies in the Menarini Group.

Specialist field Research & Development Site Berlin
Career level Experienced professionals Entry level with immediate effect
Fixed-term contract Permanent Working time Full-time

Your tasks

Your task will be the development of scientific strategies for the efficacy and safety assessment of investigational medicinal products, following EMA and FDA guidelines. You will support the development of study designs and the evaluation of clinical trials phases I - III.

You will provide us with scientific advice during the planning, conduct, evaluation and reporting of clinical trials. You will also oversee the medical monitoring and handle any medical issues during the conduct of clinical trials. The preparation/revision of clinical documentation and scientific papers (medical writing) is also one of your responsibilities, as well as the scientific reporting to national or international competent authorities and ethic committees. Additionally you will evaluate the clinical trial results and present/discuss them in the frame of marketing authorizations.

You are furthermore responsible for the analysis and evaluation of development opportunities for potential licensing products.

Your professional co-operation with clinical experts and clinical trial investigators will be will be very much appreciated, as well as your very good teamwork skills, high flexibility and determination?

Your communication skills are business fluent in German and English (oral and written) and you also have a considerably high willingness to travel?

Have we aroused your interest? Then we look forward to receiving your informative online application stating your earliest possible starting date.

Your profile

  • University degree in medicine; license to practice medicine (Medical Doctor), graduation (PhD); specialization in oncology and/or significant experience in clinical development of anticancer products, preferably in early phase drug development; demonstrated clinical program leadership
  • profound knowledge in the therapeutic area of oncology and in the treatment of the principal oncological pathologies
  • experienced in the design of clinical development plans and presentation of it to EMA/FDA (e.g. orphan designation, scientific advice, PIP, End of Phase II Meetings); knowledge of the FDA and other regulatory organizations (EU), especially with regard to the approval of novel biologics (including drug conjugates) for human use
  • comprehensive experience in the medically/scientifically due dilligence evaluation/assessment of innovative drug substances (general medicine and oncology)
  • necessary system experience/IT skills: MS office, iMedidata, MedDRA etc.

Under Employer benefits , you will learn more about us as an employer.

Have we aroused your interest? If so, please send us your informative job application documents, preferably online.

We look forward to hearing from you.

Your contact

For further questions please contact Ms. Wiedemann.
Telephone: 030/6707-3464

Address

A. Menarini Research & Business Service GmbH
Human Resources
Glienicker Weg 125
12489 Berlin