Medical Director/Associate Medical Director (U.S. Remote)

Adagene Incorporated • San Diego, CA

2d • Remote

About The Position

This role leads medical oversight for early-phase immune-oncology trials, ensuring patient safety, data integrity, and scientific rigor. The position serves as a key medical partner to investigators, driving real-time clinical decision-making, irAE management, and safety signal identification. Responsibilities include ongoing data review, safety reporting (e.g., DSUR, SUSAR), site training, and protocol optimization to enhance trial feasibility and patient recruitment. The ideal candidate combines strong I-O expertise, hands-on analytical capability, and the agility to manage multiple studies in a fast-paced biotech environment.

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

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). Develop safety management plans and educate site staff on recognizing early signs of toxicity (e.g., pneumonitis, colitis, or CRS).
• 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.
• 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