Associate Director (m/w/d) Scientific Clinical Development

Hematology/Oncology

Our client’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases.

Innovative technologies and smart development strategies are central to their approach. Success is created by their people, who focus on excellence in all they do and who collaborate closely across disciplines

 Our client is driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the team is given the opportunity to develop and flourish within this exciting and inspiring environment.

 

We are searching for a

Associate Director (m/w/d) Scientific Clinical Development

Hematology/Oncology

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    Greater Munich Area

  • Art der Anstellung:

    permanent

  • Kennziffer:

    26652

  • Aktualisierung:

    2021-06-02

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Your tasks

  • 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
  • No people management responsibilities

Your qualifications

  • Ideally PharmD or PhD in health sciences / translational research with substantial experience in clinical development and clinical research
  • Strong background in haemato-oncology, oncology or immuno-oncology
  • Experience in early and/or late drug development (Phase 1-3)
  • Ideally at least three years of relevant professional experience, ideally in the pharmaceutical or biotechnology industry
  • 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

What is offered

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Your contact person

Tilman Grumbd
Geschäftsführer

Address

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