Associate Medical Director / Oncologist (USA)

About the role

Allucent is dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients. We are looking for an Associate Medical Director to join our remote team.

Key responsibilities

• Independently provide medical monitor support to assigned clinical studies, including answering medical questions from study team and/or site, protocol interpretation, and medical review of generated data including clinical laboratory data and case report forms to ensure adherence to the protocol, consistency, and scientific validity of the data
• Assist the Project Manager in discussions with clients on safety issues or concerns when appropriate, with support from senior colleagues
• Prepare Medical Monitoring and other relevant plans for assigned studies prior to start, in accordance with contracted deliverables
• 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
• Review clinical study documents for medical consistency and relevance, including clinical trial protocol (CTP), Informed Consent (ICF), clinical study report (CSR), and other safety reports (e.g., DSUR, PSUR), with support of senior medical team members if needed
• 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' meetings, and other relevant meetings in assigned projects
• Provide 24/7 urgent medical support for medical and safety advice if required
• Train project teams on medical aspects of the trial and therapeutic training as required
• Review 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 assigned studies
• Attend 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

• MD degree
• Experience as Oncologist
• Minimum 3 years of relevant work experience with solid Oncology 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

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• 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 going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees