Clinical Medical Director
ProClinical Recruitment
Taipei
15天前

ProClinical are partnering with a prestigious biotechnology company whose offices span the globe. This organisation is seeking a Clinical Medical Director to join their team in Taiwan.

This is an exciting opportunity to join a globally expanding company which focuses on developing long-lasting anticancer treatments.

Job Responsibilities :

  • Instructing and overseeing investigator's proper performance of company therapies.
  • Providing medical oversight over clinical trials to ensure that company standard operating procedures (SOPs), company directives, and regulatory requirements are understood and followed.
  • Providing medical expertise to identify new product opportunities and portfolio development.
  • Actively participating as a member of the clinical development team for early stage products.
  • Acting as Medical Lead for Phase I and Phase II Clinical Trials.
  • Participating in Clinical Trial development by providing input into and / or developing materials such as target product profiles, protocols / amendments, and informed consents.
  • Working with the Medical Safety and Pharmacovigilance team to perform Clinical site medical monitoring as necessary.
  • Performing medical reviews of Clinical study reports.
  • Attending and presenting at investigator and company meetings as needed in collaboration with Medical Affairs.
  • Managing the integration of Clinical Programs with regulatory strategy.
  • Participating in clinical site identification, initiation oversight, and close-out.
  • Supporting the clinical operations group in the management of the CROs timely execution of clinical studies.
  • Actively participating in interactions with KOLS, in coordination with Medical Affairs.
  • Performing other duties as assigned.
  • Skills and Requirements :

  • An MD, DO, or equivalent degree with active medical licenses required.
  • Oncological experience, preferably in medical, surgical, or radiation oncology.
  • Demonstrable expertise in Clinical Trial design in oncology.
  • Demonstrable experience in Medical Affairs, Medical Safety, Medical Monitoring, and Medical Lead on Phase I and Phase II Clinical Trials.
  • A thorough understanding of clinical pharmacology with an emphasis on PK / PD of antibodies preferred.
  • Working knowledge of biostatistics, data management, and clinical operations' procedures.
  • Proficiency in the drug development process.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, persuasion, influence, and leadership.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.
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