Associate Medical Director

In this role your key tasks will include:

• Independently provide medical monitor support to assigned clinical studies, for example answering medical questions from study team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, and with the necessary support from senior colleagues, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen
• Prepare the Medical Monitoring and other relevant plans for assigned studies conducted by Allucent prior to the start of the study and in accordance to deliverables contracted.
• Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
• Assist clinical data management with MedDRA and WHO coding in assigned trials
• Assist by reviewing clinical study documents for medical consistency and relevance, with support of senior medical team members if needed, including but not limited to the clinical trial protocol ( CTP ), the Informed Consent ( ICF ) and clinical study report ( CSR ) other safety reports (e.g., DSUR , PSUR )
• Assist in the set up and conduct of Data Safety Boards ( DSMB , DMB or similar) and Dose escalation meetings ( DEC )
• Attend, participate and present in Kick-Off, Investigators’ meeting, and other relevant meetings in assigned projects, as requested.
• Provide 24/7 urgent medical support for medical and safety advice if required
• Training of project teams on medical aspects of the trial and therapeutic training as required
• Review of Protocol Deviations
• Identify study risks and provide input to the Risk plan
• Review and understand study medical deliverables laid down in the assigned study’s contract with support of senior colleagues and help track budget spent throughout their assigned study(ies)
• Attends and may need to present at major therapeutic conferences and drug development conferences
• Assure good communication and relationships with (future) clients
• Contribute and take part with support from senior colleagues as needed in client evaluations, visits and bid defenses

Requirements

To be successful you will possess:

• MD degree
• Experience as Neurologist
• Minimum 3 years of relevant work experience with solid Neurology expertise
• Good knowledge of GxP
• Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
• GDPR/HIPAA , CFR/CTR/CTD and applicable (local) regulatory requirements understanding
• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required