Associate Medical Director – Neurologist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Provide independent medical monitor support for designated clinical studies, which includes addressing medical inquiries from the study team and/or sites, aiding in protocol interpretation, and conducting medical reviews of collected data, such as clinical laboratory results and case report forms, to ensure compliance with the protocol, data consistency, and scientific integrity. When suitable, and with guidance from senior colleagues, collaborate with the Project Manager in client discussions regarding any safety concerns that may arise.

• Develop the Medical Monitoring and other pertinent plans for the studies managed by Allucent prior to the study's commencement and in accordance with contracted deliverables.

• Review Serious Adverse Events, SUSARs, and safety narratives, and conduct analysis of similar events.

• Assist clinical data management with MedDRA and WHO coding for assigned trials.

• Support the review of clinical study documents for medical consistency and relevance, with assistance from senior medical team members if necessary, including but not limited to the clinical trial protocol (CTP), Informed Consent (ICF), clinical study report (CSR), and other safety reports (e.g., DSUR, PSUR).

• Aid in the organization and execution of Data Safety Boards (DSMB, DMB, or similar) and Dose escalation meetings (DEC).

• Attend and actively participate in Kick-Off meetings, Investigators’ meetings, and other relevant project meetings as required.

• Provide 24/7 urgent medical support for medical and safety inquiries if needed.

• Train project teams on the medical aspects of the trial and therapeutic training as necessary.

• Review Protocol Deviations.

• Identify study risks and contribute to the Risk plan.

• Examine and understand study medical deliverables outlined in the assigned study’s contract, with support from senior colleagues, and help monitor budget expenditures throughout their assigned studies.

• Attend and may be required to present at major therapeutic and drug development conferences.

• Ensure effective communication and relationships with (future) clients.

• Contribute and engage in client evaluations, visits, and bid defenses, with support from senior colleagues as needed.

⛳️ Requirements

• MD degree.

• Experience as a Neurologist.

• Minimum of 3 years of relevant work experience with strong Neurology expertise.

• Good knowledge of GxP.

• Maintain good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies.

• Understanding of GDPR/HIPAA, CFR/CTR/CTD, and applicable (local) regulatory requirements.

• Strong written and verbal communication skills, including a good command of the English language.

• Professional, outgoing, and client-focused demeanor.

• Ability to thrive in a fast-paced and challenging environment of a growing company.

• Administrative excellence.

• Proficiency in various computer applications such as Word, Excel, and PowerPoint is required.

🏝️ Benefits

• Comprehensive benefits package tailored to the location.

• Competitive salary structure based on location.

• Departmental Study/Training Budget aimed at enhancing professional development.

• Flexible working hours (within reasonable limits).

• Opportunity for remote/hybrid working based on location.

• Leadership and mentoring opportunities available.

• Participation in our Buddy Program for new or existing employees.

• Internal growth opportunities and pathways for career progression.

• Financially rewarding internal employee referral program.

• Access to online soft-skills and technical training through ADP and internal platforms.

• Eligibility for our Spot Bonus Award Program recognizing exceptional contributions to projects.

• Eligibility for our Loyalty Award Program honoring long-standing employees' commitment and loyalty.