The incumbent is expected to demonstrate competency in setting up bioanalytical assays, development and implementation of strategic bioanalytical plans for key immune oncology assets, as well as providing scientific expertise and guidance to project teams and management.
Provide technical expertise for evaluation and selection of PK/ADA and Nab methodology approach and format.
Drive the development, qualification and validation of bioanalytical methods for PK, ADA and Nab assays in compliance with the appropriate regulations and regulatory agency expectations.
Identify and manage Contract Research Organizations (CROs) to support assay development, validation and clinical sample testing.
Provide logistical support in collaboration with the bioanalytical sample manager and CROs for clinical studies (including, but not limited to, sample collection/processing procedure, shipping instructions, sample reconciliation, etc.).
Oversee sample testing, monitor data quality and work closely with the clinical pharmacology group to support data analysis and interpretation.
Lead discussions and decisions related to bioanalytical assessment for each drug candidate and define the appropriate messaging associated with written documentation of such assessments.
Author, review and finalize validation reports, relevant sections of an IND and a BLA, and responses to regulatory agency questions regarding bioanalytical methods and sample analysis.
Effectively collaborate with a fully integrated team to facilitate the success of projects.
The candidate will have a proven scientific background with a
PhD or MS degree in Biochemistry, Cell Biology, Pharmacology or related field with a minimum of 10 years of relevant experience or a Ph.D. with a minimum of 7 years of pharmaceutical, biotechnology or CRO bioanalytical experience.
Extensive knowledge and hands-on experience in ligand binding and Nab assay method development and its application to PK/ADA as evidenced by laboratory skills and/or a good publication record is required.
Demonstrated knowledge of global regulatory requirements and expectations for nonclinical and clinical packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
Extensive experience in the outsourcing and external oversight of clinical bioanalytical studies conducted by qualified suppliers.
Knowledge of the biomarker assays and platforms for core therapeutic area programs in immune oncology is a plus.
Excellent oral and written communication skills and proven ability to work effectively as a member of a multidisciplinary team.
Demonstrated capacity to work in a fast-paced environment with strong attention to detail.