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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE EMAIL AVAILABLEExperienced Technology Director with 15+ years of expertise in leading digital transformation initiatives, the pharmaceutical drug development lifecycle, data programming and analysis, and clinical data management. Proven track record building high-performing teams, vendor negotiation and management, and delivering quality assured work products in regulated industries. I enjoy building partnerships and fostering a culture of kindness, professionalism, and a strong work ethic.Leadership: Mentoring and developing talent, strategic planning, and a hearts-and-minds approach for promoting a culture of accountability and innovationManagement: value-driven, ownership approach to budget oversight, vendor selection and management, contract negotiation, RFP process, daily stand-ups to ensure on-time deliverables and highest possible quality Data Engineering & Management: SQL, PostgreSQL, electronic data capture (Medidata, Veeva), PharmacovigilanceStatistical Programming & Analysis: SAS, Python, R, CDSIC (SDTM, ADaM) Pharmaceutical Drug Development: NDA - Pulmonary Arterial Hypertension, BLA - antibody therapy for pediatric neuroblastoma, Device - PAH therapy + Implantable pump delivery. Regulatory Compliance: Title 21 CFR, ICH Good Practices, ISO-27001, ISO-9001, NIST 800-53/HIPAA Software Development & Project Management: Agile, Waterfall, SDLC, GitHub, ghcr.io, Jira, Confluence Project Management: Agile, Scrum, Atlassian Jira, Jira Service Management, Confluence Bioagilytix Labs, Durham, NC Director August 2020 - March 2024 Product manager for a cross-functional collaboration between Operations, IT, and Quality to digitize the Quality Management System (QMS) proof and records artifacts. This resulted in the deployment and improvement of an internally developed, Java-based solution that streamlined manual workflows, improved data governance, freed up valuable operational resources, reduced administrative overhead, and established a foundation for modern software development practices. Transitioned the technology function from waterfall to Agile methodologies, addressing the need for quick adaptation to changing business requirements and security concerns. This initiative significantly reduced lead and cycle times from months to days, empowering the engineering team and building trust with the customer. Project manager the implementation of sprint-based workflows and Atlassian products (Jira, Jira Service Management, Confluence) to enhance development operations. This streamlined communication, improved collaboration, and accelerated project delivery.Implemented bi-weekly open office hours to foster direct customer collaboration and feedback. This forum, attended by lead software engineers and project managers, ensured that customer ideas were documented, evaluated for feasibility, and prioritized based on business needs and technical constraints. Directed and contributed to the development of proof-of-concept features to validate customer ideas before full-scale implementation. This iterative approach made work visible and allowed for continuous feedback and refinement, ensuring that delivered solutions met or exceeded customer expectations and aligned with overall product goals.Clear Creek Analytics, LLC, Raleigh, NC Freelance Consultant / Programming April 2017 - August 2020 Engaged with various customers in the pharmaceutical industry, contributing to drug development initiatives through data programming and statistical analysis (SAS, R, Python), business process mapping (Lucid, BPMN2.0), technology enablement, vendor oversight, contract management, audit questionnaires, regulatory agency compliance, and technology infrastructure, including options assessments of major clinical data platforms (Medidata and Veeva; EDC, CTMS, Pharmacovigilance).United Therapeutics Corporation, Durham, NC Director, Statistical Programming Manager, Statistical Programming Sr. Data Programmer March 2006 - March 2017 Functional Leadership - Directed a dynamic programming and infrastructure team, managing a budget of $1M+ annually and overseeing vendor selection and process improvements for pulmonary arterial hypertension and pediatric oncology marketing applications. These efforts contributed to over $1.5B in revenue in 2022. Compliance and Data Integrity - Developed and validated SAS code for standards-compliant tabulation datasets, analysis output, ad-hoc data summaries, internal publication requests, and regulatory agency requests for information. Implemented version control in GitHub to ensure the quality, traceability, and auditability of the SAS codebase, resulting in zero critical findings during regulatory submissions. Systems Architecture - Led the transition from paper-based processes to the company's first electronic data capture (EDC) system. This transformation streamlined data management and clinical operations, reducing manual data entry errors by 40% and improving overall efficiency. Additionally, oversaw the design, contract negotiation, implementation, compliance, and maintenance of complex analytical computing environments. Regulatory Excellence - Maintained a flawless record of regulatory compliance throughout tenure, representing the data management function in all relevant FDA meetings. Contributed to successful NDA, BLA, and medical device submissions to FDA and EMA, ensuring data integrity and adherence to regulatory requirements. Contributed to the development and regulatory submission of a novel combination product involving medical device, drug, and biologic components. This experience involved collaborating with multiple FDA Centers (CDRH, CDER, CBER) to navigate a complex regulatory pathway and ensure a comprehensive review of the product's safety and effectiveness.North Carolina State University, Raleigh, NCJenkins MBA Candidate (admitted for Fall 2024)ST-511: Experimental Statistics I ST-512: Experimental Statistics II ST-505: Applied Nonparametric Statistics Undergraduate Certificate in Computer ProgrammingBachelor of Science in Biochemistry Bachelor of Arts in Chemistry |
