Fran Newark

About Fran Newark

SummaryClinical operations executive with 12+ years of sponsor and CRO experience in global trial management from Phase I–IV. Proven track record in leading radiopharmaceutical studies, managing multimillion-dollar budgets, building high-performing teams, and driving operational excellence across trial planning, execution, and inspection readiness. Expertise spans regulatory strategy, cross-functional leadership, CRO/vendor oversight, and data quality. Recognized for transforming clinical operations models and achieving key development milestones.Key AchievementsTransitioned global trial management in-house, reducing costs while maintaining data integrity.Oversaw $50M+ clinical operations budgets, aligning timelines and deliverables with executive and board-level goals.Developed CRO selection/contracting process and co-led pivotal Phase 3 study protocol planning.Scaled and structured a growing clinical ops department, implementing onboarding and mentoring frameworks.Supported regulatory agency meetings, contributing to clinical development strategy and alignment.PharmaTimes Clinical Researcher of the Year 2020 – 2nd Place (CTM category)Therapeutic AreasCardiovascular: ACS, CAD, heart failure, hypertensionEndocrine/Metabolic: CKD, diabetes, dyslipidemiaNeuroscience: MigraineGastroenterology: Celiac, ulcerative colitisOncology: Lymphoma, melanoma, neuroendocrine, pan-cancerCONTACT INFO: Email: f••••••••@gmail.com

Experience

1. Vice President Clinical Operations

   Perspective Therapeutics

   Jan 2026 — Present · Durham, NC, US

   Lead global trial execution at Perspective Therapeutics from first-in-human through late phase. Expertise in radiopharma development, cross-functional leadership, vendor oversight, and building high-performing teams to deliver high-quality, inspection-ready clinical programs.

Education

• Furman University

  Bachelor of Music, Sacred Music

  2008 — 2012

Skills

• CRO
• Ich-Gcp
• Public Speaking
• Gcp
• Team Training Coordinator
• Clinical Trial Project Management
• Process Improvement
• Microsoft Excel
• Clinical Trials
• Mass Communication
• Clinical Research
• Regulatory Affairs
• Pharmaceutical Industry
• Business Process Improvement
• Spotfire
• Clinical Development
• Excel Dashboards
• Trial Management
• Team Management
• Edc
• Ctms
• Regulatory Submissions
• CRO Management
• Ms Excel Pivot Tables
• Electronic Data Capture (Edc)
• Clinical Trial Management System (Ctms)
• Clinical Operations
• Data Analysis
• Mail Merge
• Communication