Job description
As a Medical Director you will lead and oversee the medical aspects of clinical trials, ensuring that they are conducted in compliance with applicable regulatory guidelines and industry best practices. You will provide medical input and guidance to project teams, and you will be responsible for the clinical development of multiple projects. The ideal candidate will have a strong background in clinical research, as well as a solid understanding of drug development, pharmacology, and regulatory requirements.
Responsibilities:
Provide medical oversight and leadership for clinical studies conducted by the CRO
Develop and review clinical study protocols, informed consent forms, and other study-related documents
Serve as the primary medical contact for study sponsors, investigators, and regulatory agencies
Collaborate with project teams to ensure that studies are conducted in accordance with protocol, GCP, and regulatory requirements
Lead medical monitoring activities, including review of adverse events, protocol deviations, and data quality issues
Contribute to the design and implementation of clinical development plans
Collaborate with clinical operations, data management, biostatistics, and other departments to ensure that studies are conducted in an efficient and effective manner
Participate in internal and external meetings, including study team meetings, sponsor meetings, and regulatory agency interactions
Stay up-to-date with scientific literature, regulatory guidance, and industry trends
Qualifications:
Medical degree (MD or equivalent) required
Board certification in a relevant medical specialty preferred
At least 5 years of experience in clinical research, preferably in a CRO or pharmaceutical/biotech company
Strong knowledge of drug development, pharmacology, and regulatory requirements
Experience in protocol development, medical monitoring, and clinical study report writing
Demonstrated leadership skills and ability to work collaboratively in a cross-functional team environment
Excellent written and verbal communication skills
Strong attention to detail and ability to manage multiple projects simultaneously
Ability to travel domestically and internationally as needed
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact George Hebden Lee at +44 (0)20 3854 7700 or George.hebden-lee@mantellassociates.com.