Beschreibung
As a medium-sized company based in Ladenburg near Heidelberg, we attach great importance to an open and collegial working atmosphere. We are on first-name terms, enjoy working in a team and take responsibility for our work area.
Together we are working on a new treatment approach in oncology. Based on our ADC technologies, we are developing novel drugs for the targeted and highly effective treatment of cancer. ADCs are antibody drug conjugates that combine the specificity of antibodies with the...
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As a medium-sized company based in Ladenburg near Heidelberg, we attach great importance to an open and collegial working atmosphere. We are on first-name terms, enjoy working in a team and take responsibility for our work area.
Together we are working on a new treatment approach in oncology. Based on our ADC technologies, we are developing novel drugs for the targeted and highly effective treatment of cancer. ADCs are antibody drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. We use several compounds and have built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. Our goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.
We offer varied positions in research, development and administration. We accompany you on your personal career path and offer you a variety of opportunities to develop yourself further.
Curious? Then apply today and become part of our team!
We are looking to hire a
Medical Expert / Medical Scientist Oncology / Onco Hematology (f/m/d)
in a permanent, full-time position, reporting directly to the Head of Clinical Development.
Location: Ladenburg near Heidelberg or home based with regular visits to Ladenburg. As Medical Expert/Medical Scientist, you will be responsible providing medical and scientific support for the successful planning, execution, assessment, and reporting of the clinical trials run by Heidelberg Pharma:
You are responsible for creating the Clinical Development Plan, including FiH and PoC strategies, for clinical stage drugs.
You prepare high quality study concept sheets, study protocols and study reports, Investigator Brochures, submission/registration documents, publications, etc. Also, you provide medical/ scientific input and drive the creation of further relevant clinical documents.
You provide medical expertise for the clinical operations team. You are an active team member of cross-functional project teams. You also contribute to vendor selection and oversight (CROs, central laboratory, central imaging).
In addition, you provide medical/scientific input into e.g. project strategy, in-/out-licensing activities, etc. assigned. You are the scientific and medical expert in clinical development with a strong interface to non-clinical drug development. You support managing Key Opinion Leader interactions.
Furthermore, you liaison investigators, Institutional Ethics Committees/ Institutional Review Boards, consultants and academic institutions within the area of responsibility and you prepare and participate in meetings with national supervisory authorities (e.g. EMA, FDA, BfArM).
You ensure adequate safety overview and medical monitoring of the trials,including data management and periodic safety updates and organize and support DMCs as well as ensure compliance with ICH-GCP and other regulatory requirements.
Further you create and approve internal and external training materials and processes.
You are a Medical Doctor with a minimum of 5 years’ experience in the field of clinical development.
You are board certified in the field of Oncology or Hematology or you have relevant professional experience in oncological or onco-hematological drug development.
A very good understanding of clinical drug development, pharmaco vigilance, biostatistics and GCP is required for this position.
Being experienced in interactions with national supervisory authorities (e.g.EMA, FDA, BfArM) is a plus.
You are assertive, highly process-driven and solution oriented and you have the ability to work in teams as well as in matrix organizations
You possess an organizationaland planning talent with excellent communication skills (written or spoken). You appreciate independent, structured and precise work.
You are a hands-on person always willing to take over operational tasks to dri...