Adagene Incorporated

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 The study physician is a responsible member of the clinical team providing medical expertise and medical oversight for the entire clinical trial, from initial study design through final study close-out. The medical monitor provides active medical contribution to a cross-functional clinical team for each study assigned in early development. The medical monitor is responsible for the medical monitoring, safety activities, assessment and understanding of drug induced safety findings in light of patient safety for each assigned trial. Essential Functions - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities - Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements. - Maintains oversight of the conduct of the studies at the study centers (site selection, start up, monitor adherence to protocols and Good Clinical Practices (GCP), applicable guidance and study closure) - Lead sponsor study process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets. - Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner. - Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors. - Vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation. - Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines - Oversees and support Clinical Site Manager(s)/CRAs in the conduct of the trials - Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team - Review and approve vendor invoices in collaboration with the accounting team to ensure investigator payments occur in a timely manner. - Collaboration with the Director of Quality and Compliance review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements. - Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures. - Accountable for developing and managing the Clinical Operations budget. - Review draft protocol and coordinate operations in order to meet protocol requirements. - Oversees EDC/CTM entries and provide appropriately QC'd study raw data to Medical Writing team for report completion. - Perform quality control of clinical reports by utilizing protocol and procedural deviations reports, sample inventory, and medical writers. - Confirm study medication is received and dispensed for assigned projects in a timely manner. - Coordinate study monitor visits, including file review and follow-up of findings/concerns. - Other projects or responsibilities as may be required. Qualifications: - Experience in designing clinical trial plans, organizing clinical trials, and writing summary reports independently. - Knowledge about research administration, experience with investigator initiated trials. - Substantial knowledge and understanding of federal regulations affecting clinical trials and medical research is preferred. - Knowledge of and experience in experimental design, and basic understanding of statistics and statistical methods is required. - In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. - Good therapeutic and protocol knowledge. - Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods. - Strong communication and interpersonal skills. Minimum Qualifications – Education and Experience - Trained and certified as MD (or equivalent), preferably a minimum of 3 years of experience in medical monitoring of clinical trial 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.

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 The Head of Global Regulatory Affairs is a key leadership position that will oversee and is accountable for global regulatory, quality strategies and policies for Adagene. This individual will be responsible for regulatory leadership and oversight to help develop global regulatory and quality compliance strategies, and guidance. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies. This individual must leverage their extensive experience to represent Adagene in regulatory affairs in discussions with internal and external stakeholders. This role will provide global regulatory expertise and contribute to the delivery of the Clinical, R&D and Operations strategies. This individual will lead cross-functional and multicultural team and diverse environment. The candidate must have an entrepreneurial mindset, highly motivated and purpose driven leader who is able to flexibly and effectively lead and interact with multi-disciplinary teams. This individual should have experience in championing new ideas in a dynamic, international, and innovative environment. The successful candidate will have a track record of accomplishments in global regulatory affairs, project management, strong collaboration, and communication skills. This position may require travelling to our company headquarters in Suzhou, China. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are aligned with company strategies and achieve operational objectives to gain product approvals. - Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to all company personnel. - Lead, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization. - Oversee preparation and filing of all regulatory documents with the FDA, CDE and other regulatory agencies. - Develop and maintain external relationships with key opinion leaders and regulatory officials. - Direct the development of systems, practices, and processes to ensure effective ongoing review of clinical development plan, product design and/or manufacturing changes and adverse events. - Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk. - Responsible for company’s product quality and reliability to meet or exceed regulatory. - Lead company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards. - Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities. - Support the quality system, provide effective leadership support, training, and guidance to all company personnel. - Serve as the ambassador to and develop strategies for responses to regulatory related inquiries from global regulatory agencies and ensure issues are addressed in a timely manner. - Responsible for leading all regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures. - Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions. - Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management. - Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible. - Champion initiatives that contribute to global process improvements, which have a significant impact on business. - Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization’s (CRO’s), material suppliers, consultants, and vendors. - 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 - A PharmD or PhD degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and international regulatory agencies is required for this position. - Minimum 10-15 years of progressively responsible Regulatory experience in a pharmaceutical, biotechnology or related environment. Position also requires a minimum of 5-8 years of leadership experience in a global regulatory affairs role. - Must have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business. - Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP GMP, CLP guidelines and relevant requirements - Substantial experience in all aspects of regulatory affairs, including Clinical, Commercial support, CMC, with a track record of successful submissions and license approvals with CDER and CBER - Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions. - Excellent working knowledge of the US, European and Asian regulations for drugs and biologics. - Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy. - Must be able to travel (US/international) up to 25%. Preferred Qualifications – Education and Experience - RAC Certification preferred 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.