Meet some of our team…
president & founder
Drug Safety/Pharmacovigilance professional with a cross section of Compliance, Quality Assurance, and a vast variety of Audit expertise. Detailed knowledge of end to end clinical and post-marketing Drug Safety/Pharmacovigilance, filing of IND, NDA, CSR, PSUR, PADER, PBER, RSI, annual updates, and product label updates. Establishment of interdepartmental SOPs, Work Instructions, and Corporate Policies. Integral roles in multiple implementations of Argus, ARISg and Oracle AERS, detailed knowledge of FDA, EMA, ICH, GXP, and GVP regulatory requirements. Audits including PAI, FDA, EMA, vendor, QA, 21 CFR Part 11, Core Labs, Pharmacy, Laboratory, and CRO. Therapeutic areas include, but not limited to: Oncology, Infectious Disease, and CNS.
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Strategic planning; cross-functional leadership and collaboration; lean startup; entrepreneurship; biotechnology accelerator engagement; venture capital fundraising; strategic partnering; business development; project management; medical affairs; clinical development; regulatory strategy; preclinical design and execution; translational science; One Health. Also, industry knowledge of: Medical devices; biologics; drug development; rare diseases; antibiotic resistance; antimicrobial alternatives; bacteriophages; microbiome engineering; next generation microbiologic sequencing.
Chief operating officer
Susan Shea is the Chief Operating Officer for Metis Consulting Services. She is a California native and graduate of the University of Redlands. She brings small business management experience to the table, with an emphasis on helping business shift to their next level. She is a lifetime learner, and among many pursuits, has enjoyed earning her Graduate Gemologist diploma from the Gemological Institute of America. Outside of work, Susan is a part time homeschooling mom to her two kids and enjoys playing Dungeons & Dragons with friends.
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Last Updated: 27 July 2019