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.

Job Summary

Adagene’s Clinical Development organization is responsible for strategic planning, advancing and execution of clinical development programs of our innovative and differentiated immuno-oncology therapeutic assets from Phase I through NDA and commercialization. The Director of Clinical Operations, a key member of the clinical operations staff and a core member of the Global Product Team (GPT), will lead the clinical operations team in the planning, execution, and completion of clinical trials with high quality, on time and within budget. The incumbent will ensure resources and operational efficiencies to support clinical trials, and will lead, develop, and mentor the clinical operations team members as well as managing cross functional relationships with internal and external stakeholders. This is a high visibility position with great impact potential.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Leads the clinical operations team (CTMs, CRAs, and CTAs) and cross-functional clinical trial team in the planning, execution, and completion of clinical trials – ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines
  • Manages resources (including clinical trial budget) and drives excellence in the overall clinical operations activities associated with clinical trials execution, e.g., CRO bid defense, vendor and PI contracts, site selection, activation, and PI/CRS communication, etc.
  • Develop and oversees study recruitment plans, enrollment goals and timelines.
  • Supports Sr Management and GPT with clear timeline projections and assumptions.
  • Participates in protocol review meetings and contributes to ICF template development; participates in protocol deviation listing reviews/meetings, and reviews table, figure, data listings and clinical study report.
  • Provides oversight for the setup, maintenance, and close-out of all study-related materials and systems (e.g., the Trial Master File) and ensures audit readiness. Facilitates GCP QA compliance and contributes to quality variances investigations and audits.
  • Develops and leads presentations and trainings for clinical sites, team, and investigator meetings.
  • Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalated study-related issues, risks, and mitigation plans to management in a timely manner.
  • Fosters a high-performance culture that attracts and retains the best talent. Develops, trains and mentors team members to create and maintain a highly motivated, cohesive and productive team.
  • Interacts with and participates in strategy discussions with other functional areas and key stakeholders including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (i.e., central laboratory, CROs) as needed to support clinical trial activities.
  • Other projects or responsibilities as may be required.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the job.

Minimum Qualifications – Education and Experience

  • Bachelor’s degree in biological science required; advanced degree preferred
  • Minimum of 10-yrs of global clinical research experience (including 5+ years of direct clinical study and team management experience). 5+ years of working in a biotechnology company environment. Oncology study management experience.  Line management experience.
  • Prior success of developing, implementing, and managing Phase 1 through Phase 3 clinical trials
  • Prior demonstrated experience selecting and managing CROs and/or consultants
  • Proven excellence in clinical operations strategy including oversight of multiple trials and programs simultaneously
  • Demonstrated ability to develop and sustain effective relationships with external partners, vendors, investigators, and colleagues
  • Ability to contribute technical expertise to all aspects of the clinical trial process
  • Working knowledge and practical applications of industry standards as applied to ICH guidelines, GCPs and the CFR
  • Excellent interpersonal and communication, writing and presentation skills; including the demonstrated ability to work alongside senior leadership
  • Demonstrated ability to assess complex issues and propose viable, practical solutions
  • Experience with monoclonal antibody and/or biologics clinical development a plus
  • Ability to travel (~25% and variable based on project needs)

Preferred Qualifications – Education and Experience

  • Fluency in Chinese speaking and writing is a plus

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.