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.