Head of Toxicology (U.S. Remote)

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.

The Head of Toxicology will lead our toxicology activities, act as internal expert to drive all/assigned Adagene projects for new drug discovery and development. This individual will be assisting management in developing regulatory risks assessment strategies, program budgets, and timing of toxicology studies in relations to regulatory and clinical milestones. In addition, the Head of Toxicology will communicate with discovery and development colleagues to develop overall toxicology development strategies and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of toxicology findings.

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

• Work as an internal expert on all/assigned Adagene projects with core teams, to guide, develop, and drive toxicology strategies and executions with the company for new drug discovery and development.

• Assist management in developing regulatory risk assessment strategies, program budgets, and timing of toxicology studies in relation to regulatory and clinical milestones.

• Recommend, identify and/or help develop toxicology animal models that would be likely predictive of human safety findings.

• Plan, design, and effectively manage/conduct and oversee designated toxicology programs to support lead(s) identification and candidate selection through close interactions with discovery, nonclinical and clinical development functions.

• Address and resolve toxicological issues arising in drug development programs, and effectively assess the relevance of any toxicological findings to human safety.

• Drive and develop necessary animal models for toxicology studies to prioritize potential drug candidates, and to understand mechanisms of toxicities observed non-clinically and/or clinically in order to drive mitigation and/or back-up strategies to minimize potential harm to patients.

• Help building and maintaining effective CRO relationships that support the execution of exploratory toxicology/biodistribution, non-GLP and GLP toxicology studies throughout the drug R&D stages.

• Effectively communicate toxicological findings to project teams, senior management, regulators and other relevant internal/external partners and collaborators.

• Prepare, review, and edit toxicology sections of internal and external regulatory documents (IBs, CTXs, INDs, BLAs, Expert Reports, etc.), and work as company’s nonclinical representative for worldwide regulatory interactions as needed.

• Lead efforts to comply and stay up to date with relevant regulations (e.g., GLP) and regulatory guidance (FDA, EMA, ICH, etc.) to support strategic planning and conduct of safety packages for IND filing, and throughout the process to BLA registration as needed. Serve as key opinion leader for health authority documentation (e.g., guidance for industry) review and comments.

• Mentor junior toxicology scientists to nourish scientific environment to enhance rapid communication and cross-functional evaluations as well as professional development for team building and interpersonal skills as needed.

• Other projects or responsibilities as may be required.

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.

• PhD in Toxicology/Pharmacology or related science with a minimum of 10 years’ experience in a drug-discovery and development settings of a biopharmaceutical company, accompanied by at least 5 years of proven leadership experience.

• 5 years’ experience in all aspects of toxicology including general, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology.

• Experience authoring regulatory documents and interacting with global regulatory agencies. Proven track record of making major contributions to the discovery or development of one or more marketed or in-development medicines.

• Proven ability to evaluates key business / scientific challenges and completes complex, ambiguous

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.