The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
Directing bioanalytical CROs in development and validation of bioanalytical assays (PK and immunogenicity) to support clinical development of biological therapeutics. The position will work closely with clinical project teams and be responsible for managing sample analysis projects from Phase 1 to Phase 3, and accountable for scientific integrity, quality, as well as timeline of data provision from bioanalytical CROs. This position is also responsible for providing support or contributing content to bioanalytical related write-ups in IND, IMPD, NDA/BLA/MAA, IB, CSRs and other regulatory documents.
Primary responsibility for working with bioanalytical labs to develop and validate PK and immunogenicity assays of investigational biological therapeutics. Review and/or contribute methodology related contents to clinical study documentation (protocol, CSR, IB, ICF, etc.) and regulatory submission (CTD). Oversight the establishment of bioanalytical assays meet Daiichi-Sankyo project requirements for quality, time and cost.
Primary responsibility for delivery and certification of data quality to the clinical teams under agreed timelines and address special needs
Working with clinical study teams to ensure implementation of appropriate logistics of sample movements
For individual clinical study, providing standardized sample collection, storage and transmission specifications for clinical protocol and central lab documentations (Central Lab SOW, Lab Manual), to ensure the integrity and validity of bioanalytical samples
Establish, maintain and improve standardized working processes, to ensure uniform and cost effective practices in clinical bioanalysis
Providing active and knowledgeable support regarding novel assay methodologies, especially in the early lead optimization and PoC phases.
Bachelor's degree, Ph.D. degree (or equivalent) in analytical chemistry, biology, chemistry, pharmaceutical science, or related areas
7-10+ years industry (5+ years in clinical development), including bioanalytical CRO management
Compensation and seniority level/title will be commensurate with experience and qualifications. Duties and responsibilities may vary based on the position level/title
Broad and in-depth experience with developing/troubleshooting/validating PK, PD, and immunogenicity/neutralizing bioassays for biological therapeutics. Experiences with novel and emerging new therapeutic modalities (e.g. mRNA, peptides) are preferred.
Experience with assay development for antibody-drug-conjugate (ADC) drugs, as well as critical reagent development.
Experience in addressing inquiries from regulatory agencies regarding specific issues on bioanalytical methodology. Able to contribute to or formulate, if needed, strategy for regulatory interactions.
Ph.D. degree (or equivalent) in analytical chemistry, biology, biochemistry, chemistry, pharmaceutical science or related scientific field, with 10+ years relevant industry experience (5+ years in clinical development), including CRO monitoring.
Strong communication skills, ability to prioritize, skills in project management.
General knowledge of clinical pharmacology and pharmacometrics to support model-based drug development, as well as specific therapeutic area development experience (e.g. oncology, cardiovascular and metabolic diseases, pain, etc.).
Job Title Associate/Director Clinical Bioanalysis
City Basking Ridge
Functional Area QCP
State New Jersey Associated topics: dietary, disease, drug, drug discovery, nephrology, nutrition, pharmacology, protein, therapeutic, trauma
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.