Our Client, a Clinical Stage Biotechnology company are looking to expand their clinical development team. This highly dedicated, multi-disciplined team is committed to developing breakthrough medicines for serious diseases.
This interesting and diverse role will include the following tasks and responsibilities:
• Provides medical input and leadership for clinical development of one or more Clinical Programs
• Conducts periodic safety reviews on protocol and project basis. Provides medical review and assessment for SUSAR and SAE that are reported in sponsored studies.
• Builds a network of and interacts with key opinion leaders in the related oncology indications.
• Follows scientific and clinical progress in the areas of interest through monitoring of relevant literature and publications. Proactively suggests modifications of study plan and project strategy if indicated by new developments.
• Responsible for medical input in key product documents (e.g. IB, IMPD, IND, CDP, Clinical trial protocols and amendments, Clinical Study Report).
• Reviews/approves clinical relevant documents, e.g., SAP, ICF, DMP, etc.
• Participates in the selection of clinical research vendors, investigator sites.
• Acts as medical expert and point of contact for third parties (e.g. CROs, investigators, regulatory agencies, IRBs).
• Contributes to the medical assessment in case of IMP complaints, breaches or other compliance issues impacting the safety of the patient.
• Ensure, in cooperation with Clinical Operations, that sponsored studies are conducted in agreement with study protocol and applicable international and national guidelines.
• Keeps abreast of all relevant regulatory and GCP guidelines that are pertinent for conduct of clinical studies.
• Interacts with non-clinical teams and provides medical input in target selection, biomarker strategies and preclinical evaluation of development candidates.
• Medical Doctor with specialty training in internal medicine, Oncology, Immunology or any related disciplines
• Clinical experience in pediatric or medical hematology/oncology, with board certification preferred
• Experience in Hematological Malignancies or Oncology Clinical Development within academia or pharmaceutical industry
• Good knowledge of GCP and regulatory requirements
• Good knowledge of biostatistics and clinical pharmacology
• Strong leadership competencies