Medical Director - CRO - DACH

Posted 04 April 2023
Salary Competitive
LocationGermany
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameGeorge Hebden Lee

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.