Maggie Pugh Email & Phone Number

Boston, MA, US

Boston, MA, US

Durham, North Carolina, US

• Oversaw conduct and operational activities of clinical studies in Phases I/II - III
• Led study start-up for over 30 clinical sites, including regulatory document collection, IRB submissions, investigator budget negotiations, finalization of agreements, and Trial Master File (TMF) establishment
• Managed clinical research associates, reviewed site monitoring visit reports, prepared materials for pre-study and site initiation visits, and participated in monitoring visits as needed
• Served as the primary point of contact with study sponsors, vendors, coordinators, data management, and monitors to ensure that the studies were running as planned within SOPs, GCP, and ICH guidelines
• Forecasted and maintained clinical trial timelines and budgets and led study team meetings
• Established and managed vendors such as central labs, specialty labs, and site payment systems

• Worked as part of a small, cross-functional team to accelerate pharmaceutical development of a lead drug candidate, bringing it to Phase 1 clinical trials less than one year after acquisition
• Managed seven Chemistry, Manufacturing, and Controls (CMC) vendors across 20+ projects spanning the pre-clinical drug development stage through Phase 1/2 clinical trials
• Led drug manufacturing campaign with an international vendor and external consultants, developing a novel chemical synthesis route that lowered costs by ~40% and reduced production time by ~50% while increasing product.
• Oversaw RFP process for 10+ CMC projects, including crafting request for proposal documentation, reviewing vendor responses, and selecting providers based on key criteria
• Prepared and reviewed CMC regulatory documentation for Phase 1 clinical trial submissions in Australia and UK, and pre-IND filings in the U.S. for a novel anti-inflammatory small molecule drug
• Served as the company representative at ten different site audits of manufacturing and contract research organization facilities

• Screened 200+ drug candidates in ex vivo cellular migration assays using flow cytometry to analyze immune cell populations
• Performed data analysis to evaluate drug candidates and prepared PowerPoint presentations for senior management

Boston, Massachusetts, US

• Initiated, designed, and implemented a new line of studies investigating the efficacy of the company’s lead drug candidate
• Conducted in-house exploratory preclinical studies in animal models of cardiovascular, CNS diseases, and cancer to identify new disease indications and refine drug dosage regimens

• Developed a 3-D cell culture system for modeling kidney collecting duct tubulogenesis
• Isolated embryonic mouse kidneys and extracted RNA for microarray analysis

Boston, MA, US

• Graduate Student, Dr. Michail Sitkovsky’s Lab New England Inflammation and Tissue Protection Institute
• Thesis: “In vivo Studies of the Hypoxia-Adenosinergic Tissue Protection Mechanism”
• Conducted in vivo and in vitro experiments on the role of the hypoxia-adenosinergic tissue protection mechanism in inflammation and cancer
• Taught Genetics & Molecular Biology Laboratory for ~40 undergraduates per semester

Cambridge, MA, US

• Associate Scientist II, Dr. Steve Perrin’s Lab, Transcriptional Profiling
• Oversaw all aspects of Affymetrix microarray core pipeline supporting multiple research divisions
• Implemented a Beta-release Sciclone automation platform for the Affymetrix process and validated its use in production, increasing throughput by 6-fold
• Assisted in the development and troubleshooting of an in-house Laboratory Information Management System (LIMS) that allowed for accurate sample tracking and quality control

Westbrook, Maine, US

• Summer Intern, Dr. Valerie Leather’s Lab
• Assisted in development of veterinary diagnostic tests (ELISAs, PCR-based, and rapid serologic assays)
• Prepared and tested diagnostic kits for field trials

B.S., Molecular, Cellular, & Developmental Biology

M.S., Biology

High School Diploma