Medical Director/Associate Medical Director

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Job Summary 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. Qualifications & Skills 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. 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. Equal Opportunity Employer Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant. Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation. Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area. Adagene participates in the E‑Verify program in certain locations as required by law. Learn more about the E‑Verify program. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug‑free workplace. #J-18808-Ljbffr