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.
Adagene’s Pipeline and Clinical Development organization is responsible for strategic planning, advancing and execution of IND-stage and early clinical development (Phase I/II) programs of our innovative and differentiated immuno-oncology therapeutic assets. The Director of Clinical Science, a key member of the clinical development staff and an ad hoc member of the global product development team (GPDT), will participate in the development of clinical strategies and clinical development plans and study protocols across continents (US, APAC and China). The individual will play a significant leadership role in the effective and efficient execution and reporting of global clinical studies in collaboration with the clinical development teams.
- In collaboration with the Medical Director, contributes to the planning and design of clinical studies, the development of study protocol and amendments, authors and reviews the clinical sections of regulatory documents, including investigator brochures, annual safety update reports, and contributes to study documents, including AE section of ICF templates, eCRFs and SAE report forms.
- In collaboration with Data Management, reviews clinical study data, querying discrepant data/information to ensure accurate EDC data reporting; In collaborates with biometrics, develop and QC data tables, listings, and figures, and develops study-specific fit-for-purpose analyses
- Supports medical monitoring and reporting, evaluates clinical trial adverse events, reviews clinical laboratory results. Collaborates with the clinical development team on analysis and interpretation of study results; contributes to clinical study report content; reports and interprets product research results
- Assists with preparing responses to questions from Health Authorities and Ethics Committees; interactions with site IRBs/Ethics Committees and/or review committees as needed.
- Work in close collaboration with Clinical Operations to ensure the operational deliverables including preparing scientific/clinical information at SIVs, site/CRO personnel training, internal and external clinical trial related meetings, etc.
- Assists with preparation of various presentations, including meeting abstracts, posters, oral presentations and advisory boards
- Attends major scientific conferences, reviews medical literature and related new technologies; maintain awareness of external competitive intelligence and regulatory developments that could impact the product development plan.
- What may be required
- Advanced clinical/science degree required (PharmD, PhD, MS, MSN, MPH, etc)
- Minimum of 7 years of clinical trial experience in pharma/biotech industry, with demonstrated ability in managing and executing key aspects of global clinical studies with minimal supervision.
- Demonstrated experience in developing and authoring study protocols, amendments, study procedures manuals, ICF and clinical study reports, etc.
- Knowledge of relevant regulatory guidelines and ICH/GCP; well-versed in medical aspects of GCP, ICH FDA, EMEA, NICE and other relevant guidelines and regulations.
- Proven expertise in the proactive identification of issues which may impact clinical programs, and ability to work with cross-functional teams and senior management for solutions
- Strong business acumen; has knowledge of the multidisciplinary functions involved in the drug development process and can proactively integrate multiple perspectives into the clinical development process for best end-results
- Excellent interpersonal, communication (oral and written), analytical and organizational skills.
- Attention to details; problem solver.
- Ability to travel (~25% and variable based on project needs)
- Fluency in Chinese language
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.