Clinical Program Lead (m/w/d) Oncology

Ort: Hamburg, Deutschland
Gehalt: nach Absprache
Spezialisierungen: Life Sciences
Vertragsart: Festanstellung
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Our client, an international pharma company, specialised in developing and delivering a broad range of lifesaving therapies in the indication of oncology, hematology and immunology is seeking highly qualified candidates for their headquarter in Hamburg to fill the position

Clinical Program Lead (m/w/d) Oncology

Key Responsibilities:

  • Preparation of the medical scientific content of global and country-specific regulatory documents for new compounds as well as lifecycle activities for medac's product portfolio (e.g. CCDS, PSURs, DSURs, IB, IMPD, PIP, Clinical Expert Statements, Risk Management Plans, Clinical Overview; Clinical Summary, Package leaflets)
  • Supports the evaluation of potential clinical development projects for new product opportunities
  • Acting as global clinical program lead, overseeing multiple trials in a clinical development and leads the clinical program team being accountable for excellence in clinical trial strategy and leadership for design, execution and reporting ensuring high quality data
  • Undertakes product and therapeutic area reviews
  • Provides evidence-based medical and scientific input to regulatory, strategy and trial-related documents
  • Supports other departments like Marketing, Market Access, Regulatory Affairs, Pharmaceutical Development, Non-Clinical Development, Clinical Research with medical-scientific input there were necessary
  • Build relationship among medical/scientific community and with external experts

Personal skills and professional experience:

  • Medical Doctor or PhD in Lifescience
  • 5 years + clinical development experience within the Pharmaceutical Industry, preferably in the indications oncology, haematology and autoimmune diseases
  • Experience in strategic planning, designing and executing Clinical Development Programs
  • Hands on mentality with good organisational and project management skills
  • Demonstrated track record in regulatory writing of relevant documents
  • Team player with strong communication skills
  • Fluency in English and at least basic skills in German

Your point of contact for this position is Ms. Margot Huber

T: +49 (0) 176 / 557 39 180 E: m.huber(at)progressive.de

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