Sr. Global Clinical Scientist (m/w/d) Clinical Development

Immunology / Hematology-Oncology

To develop and deliver innovative biopharmaceuticals to patients who are suffering from serious diseases is the goal of our client. 

 

Therefore, our client, a Germany and US based company, has built up one of the most promising pipelines in the pharmaceutical biotech environment.

 

Being the agile motor boat on the ocean between the big oil tankers gives our client the possibility to act flexible and offers every colleague on board the possibility to take responsibility, to shape the research & development as well as the business.   

 

For one of the next upcoming monoclonal antibody which is undergoing several clinical trial programs and is near to market entry in at least one indication we are looking for an experienced and engaged

Sr. Global Clinical Scientist (m/w/d) Clinical Development

Immunology / Hematology-Oncology

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    Munich

  • Art der Anstellung:

    permanent

  • Kennziffer:

    26739

  • Aktualisierung:

    2021-07-09

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Your Responsibilities

  • Responsible for providing medical / scientific input and expertise to individual clinical trial(s) within a global development program of a disease area
  • Represent Clinical Development in Clinical Trial Teams (CTT), participate and contribute in clinical subteams and other committees needing medical support
  • For the assigned clinical trial(s) within a program, as a member of the CTT, provide medical and scientific input to: all activities related to planning, execution and reporting of clinical trials; development of trial related documents (e. g. protocols, case report forms, data analysis plan, reports, publications); development of presentation material for trial-related advisory boards, investigator meetings, protocol training, etc.
  • Ongoing review of clinical trial data, final analysis and interpretation, in collaboration with the Safety Leader and appropriate CTT members.
  • Build relationships among the clinical/scientific community and with external experts
  • Maintain sponsor oversight on data quality and product safety in clinical trials via regular medical monitoring activities in collaboration with the Safety Leader and appropriate Clinical Trial Team members. Perform hands on medical data review, as needed.
  • Support regulatory authority interactions, information requests etc (e.g. FDA and EMA) as needed
  • Based on individual expertise, perform evaluations of potential drug targets and drug candidates for future clinical development

Your Qualification

  • Ideally PharmD or PhD in health sciences / translational research with substantial experience in clinical development and clinical research
  • Background in Immunologie, haemato-oncology, oncology or immuno-oncology
  • Experience in early and/or late drug development (Phase 1-3)
  • Ideally at least one year of relevant professional experience, ideally in the pharmaceutical or biotechnology industry and/or a CRO environment
  • Prior experience in regulatory authority interactions / submissions preferred but not a must
  • Ability to critically evaluate drug targets or drug candidates based on published data or preclinical research findings and to translate these findings into clinical hypothesis testing
  • Excellent medical writing and presentation skills
  • Strategic thinker
  • Proficient in written and spoken English is a must

Your contact person

Tilman Grumbd
Geschäftsführer

Address

Optares Medical GmbH & Co. KG
Tilman Grumbd
Heiligengeist Höfe 8
26121 Oldenburg