Qualifications & Skills

• Education: M.D. or equivalent degree
• Experience: 3+ years of clinical research experience in a biotech/CRO or as a clinical investigator.
• I-O Fluency: Proven expertise in managing patients treated with checkpoint inhibitors or T-cell engagers.
• Analytical Skills: Proficiency with EDC (Electronic Data Capture) systems and a high level of comfort with "hands-on" data cleaning and medical coding review.
• Agility: Ability to balance multiple early-phase trials simultaneously in a fast-paced environment.

• Focus: Immune-Oncology (Solid Tumors & Hematology)

Key Responsibilities

• Real-Time Medical Oversight: Act as the primary point of contact for investigators to discuss patient eligibility, protocol waivers, and clinical management of study participants.
• irAE Management: Lead the identification and management of Immune-Related Adverse Events (irAEs). You will develop safety management plans and educate site staff on recognizing early signs of toxicity (e.g., pneumonitis, colitis, or CRS).
• Data Surveillance: Conduct ongoing medical review of coded data, including adverse events, laboratory results, and tumor assessments (using iRECIST or irRC) to identify safety signals or trends.
• Safety Reporting: Proactively lead the identification and evaluation of potential safety signals from clinical trial data, integrating findings into the aggregate safety profile. Lead the medical drafting and review of periodic safety reports, including Development Safety Update Reports (DSUR), PBRERs, and Suspected Unexpected Serious Adverse Reactions (SUSARs).
• Site Engagement: Conduct SIVs (Site Initiation Visits) and investigator meetings to train clinical staff on the scientific rationale and medical nuances of the I-O asset.
• Protocol Refinement: Provide medical input into the "real-world" feasibility of study designs, helping to minimize screen failures and optimize patient recruitment.