Director of Bioanalytical Sciences

Location
San Diego, CA
Posted
Dec 02, 2021
Required Education
Masters Degree/MBA
Position Type
Full time
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 is currently seeking a highly motivated and team-oriented candidate for the position of Director of Bioanalytical Sciences. The successfully candidate will lead the pharmacokinetics and immunogenicity bioanalysis internally and through CROs for antibody therapeutics in discovery and clinical development. The position requires close collaboration with Discovery and Development project teams, clinical pharmacology, and other stakeholders, developing and executing PK/ADA bioanalysis strategies necessary to facilitate the advancement our pipeline.

Essential Functions

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

  • Work as an internal expert on pharmacokinetic (PK) and anti-drug-antibody (ADA) bioanalysis for Adagene’s antibody drug and prodrug development.
  • Act as a liaison between Bioanalytical Sciences (BAS) and clinical development team, work closely with groups within BAS, Quantitative Pharmacology/Clinical Pharmacology group, clinical study teams and other working groups to establish bioanalytical deliverables and timelines for multiple projects. Ensure they are achieved to support clinical development.
  • Contribute to design of preclinical efficacy, non-GLP/Exploratory toxicology, GLP toxicology, and clinical studies to ensure that bioanalytical endpoints are appropriately incorporated.
  • Drive the activities for PK/ADA bioanalytical analysis vendor evaluation and selection, and finalization of outsourcing contracts.
  • Provide scientific oversight to bioanalytical method development, validation, and transfer for pharmacokinetics, immunogenicity including neutralizing antibody (Nab) assays to support antibody drugs and prodrugs in both nonclinical and clinical studies; plan and conduct activities for key reagent generation and QC, experimental design and study conduct that are necessary for PK/ADA bioanalysis.
  • Coordinate with Central labs and Bioanalytical labs from CROs and contribute to the finalization of lab manual, lab specification, and sample management for clinical studies
  • Serve as a point of contact for external bioanalytical CROs to ensure execution of project goals.
  • Oversee the sample analysis of pharmacokinetic and immunogenicity from nonclinical and clinical studies. Review sample analysis plans and bioanalytical data to ensure the quality and integrity of data.
  • Prepare and review sample analysis documentation and nonclinical/clinical sample analysis reports. Contributes to regulatory submissions and responses to regulatory inquiries.
  • Review clinical PK/ADA study related documents including protocols, amendments, and clinical study reports (CSRs).
  • Review SOPs, publications, and guidelines to ensure the process for bioanalysis is compliant with industry practice and/or regulatory expectations.
  • Participate in internal and external project teams. Prepare and present scientific data at internal and external meetings
  • Mentor junior bioanalytical scientists to nourish scientific environment, 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.
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
  • Ph.D. in pharmaceutical sciences, or related discipline with over 5 years of industry experience, or over 10 years of experience performing progressively advanced bioanalytical duties beyond a B.S. degree.
  • Expertise in immunological techniques such as ELISA, ECL, MSD, and/or LC-MS/MS, with extensive hands-on experience developing biologics pharmacokinetics, immunogenicity, and neutralizing antibody assays to support large molecule therapeutics.
  • Strong experiences with assay development, transfer, qualification, and validation in a GLP/GxP environment, with demonstrated strong analytical and problem-solving skills.
  • Familiar with bioanalytical regulatory guidance and industry standard practice for conducting clinical bioanalysis highly preferred.
  • Experience writing/reviewing study reports and contributing to regulatory submissions
  • Strong project management and interpersonal skills, attention to details and ability to work independently in a fast-paced, collaborative team environment


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.