Associate Medical Director / Oncologist (Brazil)

About the role

Allucent helps small-to-medium biopharmaceutical companies navigate clinical trials so they can bring therapies to patients worldwide. It is looking for an Associate Medical Director / Medical Director Oncologist to join its A-team remotely. You will work independently to safeguard the medical, clinical and safety integrity and quality of trials, acting as the medical monitor contact for protocol questions and subject safety with investigators and study sites. Oncology experience is required.

Key responsibilities

• Provide independent medical monitoring support for assigned studies, answering medical questions from the study team and sites and assisting with protocol interpretation and medical review of data such as clinical laboratory data and case report forms
• When appropriate, assist the Project Manager in client discussions on safety issues or concerns
• Prepare Medical Monitoring and other study plans before the study starts, according to contractual deliverables
• Review Serious Adverse Events, SUSARs, safety narratives and perform analysis of similar events
• Assist clinical data management with MedDRA and WHO coding
• Review clinical study documents for medical consistency, including the protocol, informed consent form and clinical study report, and other safety reports such as DSUR and PSUR
• Assist in setting up and running Data Safety Boards and dose escalation meetings, and attend kick-off and investigator meetings
• Provide 24/7 urgent medical and safety advice when required, train project teams on medical aspects of the trial, and review protocol deviations
• Identify study risks, review medical deliverables against the contract, and help track the study budget
• Present at major therapeutic and drug development conferences, maintain good client relationships, and take part in client evaluations, visits and bid defenses

Required profile

• MD degree
• Oncologist with a minimum of 3 years of relevant experience
• Good standing with local, state and national licensing and regulatory authorities
• Outgoing, representative and client-focused, able to work in a fast-paced environment

Required skills

• Good knowledge of GxPG
• Understanding of GDPR/HIPAA, CFR/CTR/CTD and applicable local regulations
• Strong written and verbal communication in English
• Proficiency with Word, Excel and PowerPoint

What we offer

• Comprehensive benefits package and competitive salary per location
• Departmental study/training budget and flexible working hours
• Remote or hybrid work depending on location, with leadership and mentoring opportunities
• Buddy program, internal growth and career progression, and referral and loyalty award programs