Senior Director, Clinical Development at Adagene Incorporated

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Aug, 26

Salary

0.0

Posted On

18 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Development Strategy, Medical Monitoring, Immuno-Oncology, Clinical Trial Design, Regulatory Interactions, Patient Safety, GCP, ICH Guidelines, IND/NDA/BLA Submissions, Toxicity Management, Cross-Functional Collaboration, Clinical Development Plans

Industry

Biotechnology Research

Description

About the Company 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. Position Summary This role is responsible for leading clinical development strategy and execution for immuno-oncology (IO) assets across Phase I–III, serves as Medical Monitor ensuring patient safety and data integrity, drives regulatory interactions (FDA/EMA), and partners cross-functionally to deliver trials on time. Key Responsibilities * Clinical Strategy & Design: Lead the creation of Clinical Development Plans (CDPs) 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 (irAEs), such as cytokine release syndrome (CRS) or neurotoxicity, and develop toxicity management guidelines. * Regulatory Leadership: Act as the lead clinical representative for interactions with health authorities (e.g., FDA, EMA), 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. Qualifications & Skills * 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. Learn more about your EEO Rights [https://www.eeoc.gov/employers/small-business/employee-rights#:~:text=Employees%20have%20a%20right%20to,(including%20family%20medical%20history).] 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 [https://sfgov.org/olse/sites/default/files/FCO%20poster2020.pdf] 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 [https://www.e-verify.gov/]. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.

Responsibilities

Lead the clinical development strategy and execution for immuno-oncology assets across Phase I-III trials. Serve as the primary Medical Monitor to ensure patient safety and lead regulatory interactions with the FDA and EMA.