Jason Pinkstaff

WORK HISTORY

EDUCATION

ABOUT JASON PINKSTAFF

An accomplished leader with 20+ years of experience in pharmaceutical and biotechnology drug development with expertise in supporting drug development from early research to post-marketing, spanning multiple modalities and therapeutic areas. Supported a broad range of modalities in both large and small molecules including antibody-drug conjugates and gene therapies. Deep expertise in several therapeutic areas including oncology, endocrinology, autoimmune/inflammation, neurology, vaccines/anti-infectives, and rare diseases. Excel in designing and implementing nonclinical programs (including oversight and interpretation of preclinical / nonclinical studies), advancing drug candidates through collaboration, and delivering high-quality data. Authored nonclinical regulatory documents from pre-First-In-Person to post-marketed products (including 5 BLAs and several sBLAs) and interacted with FDA, EMA, PMDA and several other national agencies. My management experience includes overseeing Pharmacology, Toxicology, Clinical and Nonclinical PK/PD, Clinical Pharmacology, and Bioanalytical functions and personnel with experience levels ranging from entry-level research associates to director-level PhDs.*A leader, a mentor and a cross-functional collaborator with excellent team oversight.*Strong experience in developing successful nonclinical packages (including oversight) through non-GLP and GLP studies.*Health authority interactions include pre-IND/CTA, End of Phase 2, pre-BLA/NDA/MAA and scientific advice.*Regulatory submissions include IND, CTA, NDA, BLA, MAA, PIP, PSP, RMP, IB, product label, briefing books and responding to queries.*Experience with due diligence and external partnerships including key opinion leaders.*Experience with all nonclinical functions to enable a strong translation strategy for early clinical development.