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.
The Associate Director or Director of Quantitative Pharmacology (QP) will lead our model-informed drug development (MIDD) activities in preclinical, translational and clinical stages, and act as internal pharmacokinetics (PK)/pharmacodynamics (PD) expert to drive Adagene’s portfolio advancement. This individual will serve as a modeling and simulation (M&S) leader on project teams interacting with stakeholder departments, responsible and accountable for developing robust, innovative and fit-for-purpose computational approaches to enable effective study designs and data analysis (e.g., preclinical and clinical), compound development plans, regulatory submissions/health authority interactions and efficient decision-making.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Responsible for the planning and execution of MIDD strategies via application of quantitative tools to integrate knowledge of nonclinical data (e.g., biology, pharmacology, toxicology), PK, PD (e.g., target engagement, biomarker, efficacy, safety), patient characteristics, disease states, competitive landscape to influence go/no-go decisions, support dose and dosing regimen selection (e.g., first-in-human dose, efficacious dose projections, recommended Phase 2 dose, etc.), and optimize preclinical and clinical study designs throughout drug discovery and development.
- Plan, develop, perform, and/or provide oversight for appropriate quantitative analyses (e.g., population PK/PD, mechanism, Quantitative Systems Pharmacology (QSP)), including preclinical-clinical translation and reverse translation of internal and external data to inform portfolio entry (e.g., key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape), modality selection, lead/candidate optimization/selection and other relevant R&D activities.
- Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses, as well as reporting with respect to their impact on a discovery or development program.
- Apply appropriate regulatory (e.g., FDA, EMA, NMPA, ICH) guidelines in the design and execution of preclinical and clinical development plans and studies.
- Define regulatory strategies for Quantitative Pharmacology (QP), including Clinical Pharmacology (CP) and prepare QP/CP contributions to regulatory documents including IBs, ND’s, briefing books, submission packages, responses to health authority questions, and other regulatory documents.
- Represent QP/CP in relevant external regulatory meetings (e.g., pre-IND, IND, End of Phase 1, End of Phase 2, Advisory Committee meetings) globally.
- Work effectively in a matrix environment, managing QP/CP deliverables in accordance with timelines and overall program goals.
- Participate in relevant business development (BD) activities as a QP/CP subject matter expert.
- Introduce new approaches to problem-solving, process enhancements, and improvement of efficiencies.
- Foster working environment that promotes collaboration, innovation, creativity and inclusion.
- Stay abreast of QP/CP, model-informed drug development (MIDD), modeling methodologies, regulatory guidelines and overall drug R&D process by engaging with the scientific communities (e.g., publishing, presenting at meetings, participating in interest groups within professional societies) and identify new opportunities for scientific and technical advancement within Adagene.
- Other projects or responsibilities as 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.
Minimum Qualifications – Education and Experience
- A PhD or a relevant postdoctoral training in Pharmaceutical Sciences, Clinical Pharmacology, Biological Sciences, Bioengineering, Chemical Engineering. Applied Mathematics or relevant disciplines is required.
- A minimal of 3 years (for Associate Director) or 5 years (for Director) of experiences in (bio)pharmaceutical industry or related fields is required.
- Expert knowledge and understanding of PK, PD, PK/PD, Translational Medicine and their applications in MIDD is required.
- Track record of applying QP/CP principles in IND submission and early clinical development is required.
- Understanding of industry standard and advanced M&S analysis methods, and hands-on experiences in at least one of the modeling tools (e.g., NONMEN, Mondolix, R, Winnonlin, Matlab) are required.
- Demonstrated ability to apply quantitative tools to enable rational and effective preclinical and clinical pharmacology, as well as drug discovery/development strategies is required.
- Broad experiences in pharmacometrics, mechanism-based PK/PD modeling, Quantitative Systems Pharmacology (QSP) modeling, and research of biologic therapeutics are preferred.
- Excellent written and verbal communication skills in leading meetings and interacting with team members, stakeholders, and regulatory authorities are preferred.
- Established expertise and scientific reputation through peer-reviewed publications and conference presentations is required.
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.