
Associate Medical Director – Oncologist
Posted Jul 31

Posted Jul 31
This is a fully remote position, open to applicants in United States.
• Provide independent medical monitor support for assigned clinical studies, including addressing medical inquiries from study teams and/or sites, aiding in protocol interpretation, and reviewing generated data such as clinical laboratory results and case report forms to ensure compliance with the protocol, consistency, and scientific integrity of the data. Assist the Project Manager in discussions with clients regarding safety issues or concerns as appropriate, with support from senior colleagues.
• Develop Medical Monitoring and other pertinent plans for studies conducted by Allucent prior to the commencement of the study, in alignment with contracted deliverables.
• Assess Serious Adverse Events, SUSARs, safety narratives, and conduct Analysis of Similar Events.
• Support clinical data management with MedDRA and WHO coding in assigned trials.
• Review clinical study documents for medical accuracy and relevance, with assistance from senior medical team members when 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 establishment and execution of Data Safety Boards (DSMB, DMB, or similar) and Dose escalation meetings (DEC).
• Attend, engage, and present at Kick-Off meetings, Investigators’ meetings, and other relevant meetings for assigned projects as requested.
• Provide 24/7 urgent medical support for medical and safety advice as required.
• Train project teams on medical aspects of the trial and therapeutic training as needed.
• Review Protocol Deviations.
• Identify study risks and contribute to the Risk plan.
• Understand and review study medical deliverables outlined in the assigned study’s contract with support from senior colleagues, and assist in tracking budget expenditures throughout their assigned study(ies).
• Attend and may be required to present at significant therapeutic and drug development conferences.
• Ensure effective communication and maintain relationships with (future) clients.
• Participate in client evaluations, visits, and bid defenses with support from senior colleagues as needed.
• MD degree.
• Experience as an Oncologist.
• Minimum of 3 years of relevant work experience with substantial Oncology expertise.
• Strong understanding of GxP.
• Good standing with local, state (in the US), and national licensing and regulatory authorities, as well as certifying bodies.
• Knowledge of GDPR/HIPAA, CFR/CTR/CTD, and applicable (local) regulatory requirements.
• Excellent written and verbal communication skills, including a strong command of the English language.
• Representational, outgoing, and client-focused.
• 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.
• Comprehensive benefits package tailored to location.
• Competitive salaries based on location.
• Departmental Study/Training Budget for professional development advancement.
• Flexible working hours (within reason).
• Opportunity for remote/hybrid working depending on location.
• Leadership and mentoring opportunities.
• Participation in our Buddy Program as either a new or existing employee.
• Internal growth opportunities and career advancement.
• Financially rewarding internal employee referral program.
• Access to online soft-skills and technical training via ADP and internal platforms.
• Eligibility for our Spot Bonus Award Program in recognition of exceptional contributions to projects.
• Eligibility for our Loyalty Award Program acknowledging the loyalty and commitment of long-standing employees.
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