Niki Low

Vice President, Project Management @Biomea Fusion

San Francisco, CA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Apr 2021 — Present

Vice President, Project Management @Biomea Fusion

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EDUCATION

N/A

Iowa State University

Bachelor of Science (BS)

N/A

The University of Texas at Dallas

MBA Degree

N/A

UC Berkeley Extension

Software Project Management Program

N/A

University of California, San Francisco

Entrepreneurship for Life Sciences and Healthcare Startups

N/A

Stanford University

Advanced Project Management Program

SKILLS

Product DevelopmentLeadershipDrug DevelopmentGcpBiotechnologyStrategyPharmaceutical IndustryFdaMarketing ResearchValidationCrm21 Cfr Part 11IntegrationProgram ManagementCtmsComputer System ValidationProduct MarketingGxpCross-Functional Team LeadershipClinical DevelopmentIT StrategyChange ControlLife SciencesProject Management

ABOUT NIKI LOW

Strategic, Tactical and Result-driven Leader with 20+ years of Program Mgmt. experience in Pharmaceutical and Diagnostics industries. Strong integrator with direct Project / Program / Alliance mgmt. and team leadership skills with proven track record in leading and managing technically complex, cross-organizational, multi-stakeholder programs/portfolios/projects successfully. Expert with the start-up and execution of preclinical and clinical-stage programs from Phase 1 to Phase 4, including driving milestone regulatory submissions such as IND, CTA, BLA and NDA.Excellent collaborative & interpersonal skills in building relationships with diverse stakeholders. Proficient in leveraging resources to meet diverse business demands. Expert in creating positive team environment to recruit, manage, mentor and supervise teams globally. Decisive leader with strong analytical and problem solving skills.Competencies:Portfolio / Program Management | Drug & Clinical Development | EMR / EHR / HIE management | Product Development / Strategy | System Requirements Gathering | Agile Development | Resource Planning & Utilization | Software Design, Application and Implementation | Alliance Management with collaborators, vendors & partners | Continuous Process Improvement | Risk Assessment & Mitigation | Systems Integration and Migration | Mobile Development | CRM / ERP Implementation | Manufacturing & Laboratory Migration | Contract Management |Supply & Material Chain management | Organization Transition & Change management | BI Reporting Metrics & Analysis | Regulatory & Quality Management |

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