Mary Lynn Baniecki
Sr. Director Translational Medicine @ Pfizer | Pharmaceutics, Clinical Development
- Role
- Head of Anti-infectives Translational Medicine at Pfizer
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Mary Lynn Baniecki
A life sciences professional with 20+ years in therapeutic and diagnostic development. Proficient in translational medicine, advancing drug discovery from proof of concept to clinical phases (1-3) and post-marketing approval. Skilled in developing translational biomarker strategies, including omics and real-world data, to support clinical development for a range of diseases such as respiratory, inflammatory, metabolic, and viral conditions. Experienced in FDA interactions and submissions, including EUA, NDA (PAXLOVID), and 510K (Lucira). Responsible for translational strategies and authoring components of the target product profile/claim, clinical development plan (CDP), investigator brochure (IB), regulatory documents and core labelling, and post marketing approvals and label expansion. Experienced in global regulatory submissions and agency engagement. Demonstrates expertise in molecular diagnostics, biochemistry, and multi-omics (proteomics, genomics, metabolomics) approaches, fostering collaboration to enhance drug development pipelines and patient outcomes. Adept at integrating genomic and molecular-based diagnostics into clinical development, while leveraging leadership skills to build effective teams. Committed to driving science-led solutions to improve patients’ lives.
Experience
Head of Anti-infectives Translational Medicine
Jul 2023 — Present · Cambridge, MA, US
Education
Gannon University
Bachelor’s Degree, Biology
1990 — 1995
Broad Institute of MIT and Harvard
Fellow, Chemical Biology/Infectious Disease
2006 — 2008
Stony Brook University
Doctor of Philosophy (Ph.D.), Molecular and Cellular Pharmacology
2000 — 2003
Northeastern University
Master’s Degree, Pharmacology
1996 — 1999
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