Medical Director/Associate Medical Director

Adagene Incorporated • San Diego, CA

1h

About The Position

This role involves providing medical oversight for clinical trials, with a focus on Immune-Oncology (I-O) in Solid Tumors & Hematology. The position requires real-time medical oversight, management of Immune-Related Adverse Events (irAEs), data surveillance, safety reporting, site engagement, and protocol refinement.

Requirements

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

Responsibilities

• Act as the primary point of contact for investigators to discuss patient eligibility, protocol waivers, and clinical management of study participants.
• Lead the identification and management of Immune-Related Adverse Events (irAEs), including developing safety management plans and educating site staff on recognizing early signs of toxicity.
• Conduct ongoing medical review of coded data, including adverse events, laboratory results, and tumor assessments, to identify safety signals or trends.
• 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).
• Conduct SIVs (Site Initiation Visits) and investigator meetings to train clinical staff on the scientific rationale and medical nuances of the I-O asset.
• Provide medical input into the "real-world" feasibility of study designs, helping to minimize screen failures and optimize patient recruitment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree