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!
Head of Clinical Development, Oncology / Onco Hematology (f/m/d)
in a permanent, full-time position, reporting directly to the Chief Medical Officer.
Location: Ladenburg near Heidelberg or home-based with regular visits to Ladenburg. As Head of Clinical Development and member of the Executive Management Team, you will overall be responsible for leading the Clinical Department (Clinical Development & Clinical Operations), managing the internal interfaces and the partnership to our strategic and operational external partners. Providing medical, scientific, strategic and operational leadership for the successful planning, execution, assessment, and reporting of the clinical trials run by Heidelberg Pharma includes the following responsibilities:
You are accountable for the overall Clinical Development Strategy of our development portfolio and the creation of Clinical Development Plans, including FiH and PoC strategies, for clinical stage drugs and the implementation into the Integrated Global Development Plan. Current focus is on Phase 1 and Phase 2 considering the needs for a Phase 3 program and market access.
You are accountable for the preparation of 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, always working in a hands-on mode.
You provide medical expertise for the clinical operations team. Furthermore, you are an active team member of cross-functional project teams and the Benefit/Risk Assessment Team. You also are accountable for appropriate vendor selection process, vendor contract negotiations, and vendor oversight (CROs, central laboratory, central imaging).
In addition, you provide medical/scientific input into,e.g. business plan, project strategy, in-/out-licensing activities, etc. as assigned. You are the scientific and medical expert in clinical development with a strong interface to non-clinical drug development. You manage Key Opinion Leader interactions, maintain and develop KOL network, establish and maintain relationships with scientific advisors.
You will represent HDP interests in e.g. Joint Development Committees and Joint Steering Committees established with partners asappropriate.
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 are accountable to ensure adequate safety overview and medical monitoring of the trials including periodic safety updates by the team or yourself, you organizeand support DMCsas well as you assure compliance with ICH-GCP and other regulatory requirements.
Further you cr...