The Director, Biostatistics leads clinical development programs for the Biostatistics function and helps lead the biostatisticians within the Data Science Department (covering Biostatistics, Clinical Data Management, Statistical Programming, Study Endpoints, & HEOR).
Manage IT strategy, application roadmap, and project portfolio for R&D functions including lab and research informatics solutions (ELN, LIMS, CDS, Compound registration/inventory, Assay data management, SAR, PK/PD), clinical informatics (EDC, Data Management, eTMF, RIM, Adverse Event, SAS), and Quality solutions (QMS, LIMS). Work with R&D, IT, Finance, and Quality Systems partners to prioritize efforts to best align with function and company goals and to align with overall IT strategy and architecture.
Senior leader and brand management innovator who drives successful marketing and revenue growth for our U.S. GI product, LINZESS (linaclotide). Strategic thinker and analytical professional with proven leadership skills.
The Drug Safety & Pharmacovigilance Department (DSPV) Q&C Manager is responsible for supporting the DSPV Quality & Compliance activities based on relevant regulations, procedures, and contractual requirements. Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will support the management of all DSPV SOPs, CAPAs and inspection related activities, as well as leading a QC system for all DSPV documents.