Stacey Lense Page * September ****

STACEY LENSE

Hartsdale, New York ad1b70@r.postjobfree.com

516-***-**** linkedin.com/in/stacey-lense-967357

SENIOR EXECUTIVE CLINICAL OPERATIONS LEADER

Accomplished, executive-level, cross-functional leader with 30 years of experience. Encompasses a highly proactive “roll up her sleeves” attitude, while exceeding expectations daily. A strong communicator and business partner, effective in navigating ambiguity and leading by example. Comfortable in a start-up environment or one seeking innovation. Performance-oriented with unique, interrelated expertise in Pharmacovigilance, Strategy, Medical Research, Clinical Operations, Regulatory Affairs, Data Management, and Medical Writing. Recognizes the importance of keeping a team connected, empowered, and collaborative while assuring a safe and inclusive environment. Passionate about mentoring individuals to bring their best selves forward, supervising with humanity, and delivering an exceptional client experience. Procured and directed $500+ million in research activities FDA approval on 8 drugs and 1 device

2 drugs currently in review at FDA and another completing NDA submission in 2024 Experience

Synergy Research, Inc., Hackensack, NJ

Contract Research Organization specializing in start-up companies with growing pipelines and expanding programs Senior Vice President, Global Operations 2021 – Present Vice President, Clinical Operations 2010 – 2021

Reporting to the Chief Executive Officer. Extensive history in team building, leading business operations, and overseeing complex development programs, along with corporate initiatives and culture. Strategically manage all phases of Sponsor research and vendor relationships. Establish clear and focused priorities to obtain key results on-time and within budget. Effective in networking and developing strong business and personal connections with KOLs, C-Suite executives, and Clinical Investigators, with an emphasis on long-term relationship building.

• Sets vision, budgets, and processes for clinical/business operations excellence to guarantee flawless execution

• Drives Synergy’s strategic plans and resource allocation to ensure 100% client satisfaction and extraordinary service

• Provides strategic input and leadership on decision-making issues affecting the organization, with an emphasis on evaluating potential acquisitions or partnerships

• Prevailed in tripling the company’s resources in a methodical yet aggressive approach while overseeing end-to-end clinical, regulatory, data management, medical writing, and pharmacovigilance development strategies

• Ongoing interpretation of clinical trial and efficacy data for strategic, regulatory, and pharmacovigilance observation

• Partners with CEO for business development activities and ensures prosperous executive client relationships

• Develops and upholds the company’s culture and mission/vision

• Never received an FDA Form 483 or have been placed on clinical hold

• Proven leadership of 18+ direct reports and in charge of a group of 50+ Sideromics, Inc., East Stroudsburg, PA

Novel drug company working to develop anti-infectives Vice President, Clinical Operations 2014 – September 2022 Reported to Chief Executive Officer and President. Managed non-clinical discovery programs and contributed to company-wide strategic planning, budget development, and financial management. Managed corporate communications, prepared updates/status reports for Executive Management and Board of Directors defining critical path and risk mitigation.

• Oversight and management of nonclinical operations

• Collaborated to identify which candidate therapy had the greatest probability of success and assess its safety

• Reviewed regulatory documentation in support of IND, NDA, PMDA submissions

• Point-person coordinating intial activities for a successful transition of non-clinical research to a clinical setting

• Responsible for the operations of the Institutional Animal Care and Use Committee (IACUC)

• Strategic partner to Board of Directors and key executives to establish short-term objectives and long-range goals

• Served as the company's external representative to investors, stakeholders, employees, and public Stacey Lense Page 2 September 2023

Veritas Research, Inc., Massapequa, NY

Contract Research Organization specializing in assisting start-up companies grow their teams and act as a liaison with their vendors

Principal and Executive Vice President 2000 – 2013 Successful strategic advisor to start-up drug and biotech organizations. Deep operational experience in creating, scaling, and running services and support functions in high-growth businesses. FDA panel member (2006 – 2007) that worked to help reduce healthcare disparities for human subjects participating in clinical trial research.

• Business development activities included networking with potential partners resulting in $75 million in new business

• Examined risks and program potential while estimating partners' needs and goals

• Evaluated the company’s financial, operational, sales, and marketing structures to plan for continual improvement and increase inefficiencies

• Built, mentored, and managed a team of 30+ internal employees/consultants and external vendors to support advancing business activities

• Supervised and managed clinical trial protocols, clinical study reports, IND safety reports, AE/SAE narratives, DSURs, White Papers, ICFs, and Phase 1 to 3 Investigator’s Brochures

• Conducted Global Phase 3 Investigator Meetings and led Scientific Advisory Boards

• Secretary and facilitator of numerous Data Monitoring Committees

• Vetted, selected, and managed long-term relationships between large CROs and Sponsor clients

• Developed first-in-class Blackberry App CRA Toolbox™ to provide CRAs with a customized calculator, converter, and data/process confirmation tool built expressly for monitors by monitors International Pharmaceutical Research, Inc., Norwalk, CT Contract Research Organization

Sr. Project Manager 1998 – 2000

Project Manager and Manager, Clinical Data Reviewers 1997 – 1998 Quality Assurance Associate 1992 – 1997

• Planned and managed all aspects of clinical trials including Sponsor relationship, site selection and initiation, supervised IRB submissions, resource allocation and scheduling, interactions with data management and statistics, Investigator Meeting planning, and budgeting and assured compliance with SOPs, GCPs and ICH Guidelines

• Coordinated multi-disciplinary project team development and strategic planning

• Established and designed an in-house Clinical Data Reviewers (CDR) department

• Contributed to the development and operation of IPR’s in-house auditing department

• Contributed to the development of the first fax-based remote electronic data monitoring system

• IRB administrator

Continuing Professional Development and Affiliations Drug Information Association (DIA)

Association of Clinical Research Professionals (ACRP) Pharmacovigilance & Drug Safety Network

Regulatory Affairs Professionals Society (RAPs)

Department of Health and Human Services – OSDBU – 2003 Steering Committee Member- Health Disparities and Minority Health Education

Nassau Community College

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Stacey Lense Page 3 September 2023

Indication/Drug/Device Experience

Orphan indications

• Fabry disease

• Gaucher disease

• Cystinosis

• Hunter syndrome

• Paroxysmal Nocturnal Hemoglobinuria

Oncology

• Drugs

o NSCLC – Drug approval KEYTRUDA®

o Large tumors

o Thyroid – Drug approval Lenvima®

o Hepatocellular carcinoma

o Breast – Drug approval Halavan®

o Prostate

o Pancreatic

• Colorectal Cancer Diagnostic Device

• Gene therapy

Ophthalmology

• Drugs

o In review with FDA – Wet AMD (Feb 2023)

o NDA submission – 2Q2023 - Pain relief post-cataract surgery o Thyroid eye disease

• Device for cataract surgery

Hematology

• Drug approval PNH- Empaveli®

• Hyperbilirubinemia in neonates

Endocrinology

• Drug approval – Type 1 and Type 2 diabetes - Afrezza®

• Fidarestat

• Device

Pulmonology

• Drug for chronic cough

Central Nervous System

• Alzheimer’s – Aricept® post-market

Psychiatry Agent

• Disulfiram – off label indication

Diagnostics

• Breast cancer

• Colorectal cancer

Gynecology

• Device marketed- CSafe®

Stacey Lense Page 4 September 2023

• Pelvic inflammatory disease

Urology

• Device for pelvic organ prolapse

Infectious Disease

• Anti-infective

Gastroenterology

• Rx OTC Switch

o Pepcid®

o Prevacid®

o Prilosec®

o Zantac®

Nutraceuticals

• Cold-eeze®

• Urea-NA®

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