Senior Director, Clinical Development (U.S. Remote

Job Title

Adagene Inc. is seeking a professional for a role focused on leading clinical development strategy and execution for immuno-oncology assets across Phase I–III, serving as Medical Monitor ensuring patient safety and data integrity, driving regulatory interactions, and partnering cross-functionally to deliver trials on time.

• Clinical Strategy & Design:
  Lead the creation of Clinical Development Plans and design and draft Phase I–III clinical trial protocols for IO assets, ensuring scientific rigor and alignment with corporate goals.
• Medical Monitoring:
  Serve as the primary Medical Monitor for assigned studies, overseeing patient safety, reviewing SAEs, and providing expert medical judgment on clinical data. Provide expert medical management of Immune-Related Adverse Events, such as cytokine release syndrome or neurotoxicity, and develop toxicity management guidelines.
• Regulatory Leadership:
  Act as the lead clinical representative for interactions with health authorities, and author key clinical sections for IND, NDA, and BLA submissions.
• Cross-Functional Collaboration:
  
  Partner closely with Clinical Operations, CMC, and Regulatory Affairs to ensure study milestones are met on time and within budget.

• Education:
  
  M.D., M.D./Ph.D., with a specialization in Medical Oncology or Hematology/Oncology.
• Experience:
  
  7+ years in clinical development within the biotech or pharmaceutical industry.
• Therapeutic Expertise:
  Deep knowledge in IO therapies for oncology.
• Mindset:
  Proven ability to thrive in a "player-coach" role within a fast-paced, startup environment.
• Compliance:
  Expert understanding of GCP, ICH guidelines, and global regulatory requirements.

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. 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. Adagene participates in the E-Verify program in certain locations as required by law. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.