Reena Lynam
Sr. Director, Clinical Operations
- Role
- Sr Director Clinical Operations at Ratio Therapeutics
- Location
- Sarasota, FL, US
- LinkedIn followers
- 500 followers
About Reena Lynam
Clinical Operations | Building and Scaling Clinical Teams | Global Phase Oncology & Rare Disease | Operational Innovation & AI Integration | Board EngagementClinical Operations Executive with 20+ years of experience leading global Phase programs across oncology and rare disease within both public and private biotechnology companies, including Cue Biopharma, Leap Therapeutics, and Biogen.Throughout my career, I have built and scaled clinical operations functions, overseen multi-million-dollar development portfolios, and led Phase trials contributing to regulatory approval of Alprolix®. My experience spans registrational studies, IND-enabling programs, CRO and vendor governance, and cross-functional partnership across Regulatory, QA, Biometrics, and Medical Writing.I regularly partner with executive leadership and Boards on clinical strategy, risk mitigation, and portfolio execution, aligning operational infrastructure with long-term development goals.
Experience
Sr Director Clinical Operations
Nov 2025 — Present · Boston, MA, US
Lead clinical operations for biotechnology firm developing best-in-class targeted oncology radiotherapeutics, reporting to Vice President, Clinical Operations. Oversee broad operational scope, including audit readiness, service provider oversight. • Establish clinical standards and quality frameworks aligned with GCP and regulatory requirements.• Strengthen operational infrastructure, SOP development and inspection readiness• Integrate AI-driven tools into clinical workflows to enhance efficiency, CRO identification and scalability.
Education
Suffolk University
Master Health Administration
Cedar Crest College
Bachelor of Science
Skills
- Clinical Monitoring
- Clinical Trial Management System (Ctms)
- Clinical Research
- Ich-Gcp
- Regulatory Submissions
- CRO
- CRO Management
- Clinical Development
- Edc
- Cell Culture
- Ctms
- Oncology
- Biotechnology
- Drug Development
- Gcp
- Pharmaceutical Industry
- Fda
- Clinical Trials
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