Strategic Clinical Affairs Executive
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Skilled at strategic planning, due diligence, and managing teams to attain peak potential and engagement. Absorb and analyze information to help teams make better decisions. Possess a growth mindset and motivated by solving complex problems under tight timelines and in compliance, which are critical to organizations’ reputations and the ability to drive business objectives to completion.
Dedicated to continuous improvement and thriving when managing critical / crisis situations. Adept at problem-solving in the moment and anticipating issues to apply preemptive solutions. Reliably deliver quality clinical data for regulatory and marketing purposes.
OLYMPUS CORPORATION OF THE AMERICAS - Vice President, Global Head of Clinical Affairs
Owned all aspects of clinical study operations, strategy, and planning for > 50 projects worldwide with > 35 US, EU, and Japanese staff members with budget > $14M. Gained alignment from FDA and guided cross-functional team through root-cause analysis and study restart plan for business-critical, 522 Postmarket Surveillance Study.
Senior Director, Clinical Affairs, Interventional Surgery
Inspired associates to maximize engagement in projects and expand individual talents to accelerate timelines. Managed global clinical affairs strategy for products in hernia repair, breast reconstruction, and surgical hemostasis, including new business development and Post-Market Clinical Follow Up (PMCF) studies for compliance with European Union Medical Device Regulation (EU MDR).
C.R. BARD
Director, Clinical Affairs, Davol
Set department vision and mission. Built and maintained clinical affairs function in support of product development, maintenance of business continuity (e.g., problem-solving of manufacturing issues), and business objectives, including budget/contract/vendor management, and L&A activities. Grew and maintained strong internal and external relationships / partnerships through acquisition by and integration with BD.
JOHNSON & JOHNSON, INC. (J&J)
Manager, Clinical Research, Advanced Technologies and Regenerative Medicine
Led drug, device, and biologic clinical research in US, EU, Asia and Australia that included CRO/vendor management, strategic plans for reimbursement. Managed 11 full-time and contract resources across 3 J&J operating companies. Managed and forecasted departmental budget of $6M+. Created and implemented CAPAs (corrective and preventive action plans). Authored clinical content for IND, IDE, and 510k applications and verbal and written communications to FDA.
