Peter Lyn Email & Phone Number

La Grange, New York, United States

Leader of family business with the purpose of building young farmers and soccer players. Created a farm from scratch. Learned principles of all-natural (pesticide-free) regenerative farming and built farm-related business enterprises (Pick Your Own Blueberries, Pumpkins, Strawberries, and year-round Superfoods Market) with minimal startup costs. Supported internships, volunteerism, and agricultural programs to benefit schools, charities, chefs, restaurants, and the local community.

Summit, New Jersey, United States

Performed/managed all activities related to execution of contracts with clinical investigators, vendors, consultants, and other agreements as needed. Developed processes, procedures, and agreement templates. Facilitated the development of SOWs and budgets related to Medical Affairs research agreements for MDS/AML, MM, and CLL Registries, Investigator Initiated Trials with KOLs, and Cooperative Groups. Identified critical issues and collaborated with Legal. Tracked, monitored, and reported the progress of agreements to top management. Performed Fair Market Value benchmarking when analyzing budgets.

Berkeley Heights, New Jersey

Products/Business Areas: Pomalyst (MM), Medical Affairs, CONNECT MM, CLL, MDS/AML RegistriesPerformed/managed all activities related to the development of study budgets and execution of contracts with CROs and ancillary vendors performing clinical trial services. Prepared and oversaw study specific RFPs, competitive bidding negotiations, vendor selection, benchmarking and sourcing strategy. Prepared contracts; negotiated legal terms and conditions, scope and costs. Ensured timely change order finalization and implementation for high complexity projects. Developed and utilized metrics and benchmarking to monitor vendor performance and control budgets. Contributed to strategy and new processes, identified new best practices and continuous improvement. Cascaded business intelligence as appropriate.

Raritan, New Jersey

Products/Business Areas: Stelara (IBS, Crohn’s)Negotiated Phase I-IV services agreements related to clinical studies in Immunology. Escalated issues and implemented corrective actions. Conducted robust contract reconciliations.

New York, New York

Interim Operational Lead responsible to introduce and manage Aquavit’s startup activities.

Jersey City, New Jersey

Products/Business Areas: Bystolic (HTN), Celexa (Depression)Strategic Sourcing Lead for R&D Services related to clinical trials. Developed and conducted formal corporate-wide sourcing assessments and strategies. Negotiated MSA and SOW templates, terms and conditions. Improved performance management by establishing minimum requirements/service levels and milestone-based incentives/penalties. Optimized RFP templates. Relationship and performance management, financial reporting and resourcing.

Products/Business Areas: Zometa (Prevention of bone fractures in cancer patients), Gleevec/Glivec/Tasigna (CML), Femara (Breast Cancer), and Exjade (Chronic Iron Overload), Oncology adaptive design trials. Oncology Global Clinical Operations: 2005-2009Associate Director, Oncology Outsourcing (Contracts/Vendor Management & Strategy): Successfully developed the Oncology-specialized Phase I thru IV preferred provider selection and management strategy, specializing in adaptive design for targeted therapies. Ensured service providers delivered high quality services on time and within budget. Received Novartis Oncology Global Innovation Quality & Productivity (IQP) Award for Best Customer Service initiative by minimizing startup times for Medical Affairs trials. 2001-2005Senior Project Liaison Manager: Negotiated and optimized global allocations and recruitment and managed internal and external resources. Asia-Pacific Growth Champion.

Rahway, New Jersey

Products/Business Areas: COX-II inhibitors, VIOXX (osteoarthritis and rheumatoid arthritis).1997 - 2001Global Clinical Trial Manager for COX-II inhibitor trials. Led internal and external cross-functional teams to accelerate the execution of large Phase II and III clinical trials in patients with osteoarthritis and rheumatoid arthritis. Oversaw all aspects of clinical trial planning and conducted budgeting and forecasting/accruals. Ensured ICH/GCP and Regulatory compliance. Negotiated CRO/vendor and site contracts, and managed performance and metrics. Co-authored protocols and consent forms. Performed UAT EDC testing, data review, issued and resolved queries to lock clean databases. Completed patient safety packages for adjudication committees. Wrote SAE narratives, Clinical Study Reports, and Integrated Summaries.1996 - 1997 Data Coordinator, Clinical Biostatistics and Research Development Systems: Developed EDC. Performed data imports and reconciliation. Wrote SQL queries. Performed protocol-specific presentations at investigator meetings. Designed standard and protocol-specific CRFs. Coded, verified, queried, and tracked incoming CRFs. Created and maintained data handling guidelines, and facilitated interim analyses.

Products/Business Areas: Cisplatin Regimens, Carboplatin Regimens, Taxol (GU Oncology Investigational)1994 - 1996Research Coordinator, Epidemiology and Biostatistics:Developed and implemented institution-wide clinical research database and patient registration systems. Database design, testing, quality control and assurance. Standardized electronic and paper data collection forms and tools. Mentored and trained study coordinators.1992 - 1994 Study Coordinator, Genitourinary Oncology: Managed chemo, radiation and surgical oncology clinical trials for over 300 cancer patients. Supervised clinical trials processes and personnel. Performed IND safety and IRB submissions. Supported pharmaceutical and government sponsor monitoring visits and audits. Conducted patient screening, recruitment and follow-up. Collected, synthesized and reported patient status and study updates.