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Medical Director Clinical Trial

West Orange, NJ
January 31, 2024

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West Orange, NJ ***** 973-***-****

LinkedIn Profile

Medical Director, SME, Senior Medical / Business Professional in Medical Affairs and Ops. Able to manage Global Alliances, Program & Project Management Developing Efficiencies in Clinical Trials. Provides market-based Comp Intel - Therapeutics, Devices & Med Systems.

Highly Innovative Entrepreneurial Resourceful Problem Solver Digital Native

Areas of Expertise

• Strategy, Bus. Development and Implementation

• Competitive Med. Intelligence / Med. Market Analysis

• Program / Project Man. of all Sizes & Complexities

• Clinical Trial - Analysis, Efficiencies CRO / CMO Vendors

• Marketing - Global / Strategic / Targeted

• Epilepsy / CNS / Surgical / Launch Experience

• Med. Comm. Strategies / Programs Development

• Hospital Planning, Mergers, New Facilities

• Therapeutics / Devices / Technical Systems

• Medical Publishing / Portal Development

• Medical Alliance Man. & Grants Management

• Med. Software Eval. / A.I., Hardware Dev. / Dig. Native

• MD / KOL / Patient Recruitment / Advisory Boards

• High Level Negotiations – Able to Build Consensus

Accomplishments Medical / Business Consultant and Developer (25+ years):

•Currently Developing strategies/initiatives increasing clinical trial efficiencies Point B / Takeda (contract)

•Post Covid consulting projects have yielded numerous very successful entrepreneurial ventures.

•CNS Epilepsy – as Medical Director / Brand Ambassador for Engage Therapeutics (now UCB) helped recruit and manage their Phase II Clinical Trial and with daily CRO management responsibilities.

•US / International MD/KOL-Very successful marketing efforts helped complete the Phase II

Clinical Trial of Staccato Alprazolam - on-time and on-budget. Phase III Trial completion is expected to lead to release of Staccato Alprazolam in 2024 of a therapeutic rescue / inhaler designed to stop seizures. Great success - introducing Engage Therapeutics to UCB who acquired Engage in 2021.

•Device experience - Implantable epilepsy device experience DBS, RNS, VNS and Reveal Cardiac Monitors

•Marketing and Recruitment Strategies – Prior projects in Phase II/III/IV MD / KOL & Site Campaigns:

Designed direct mail outreach, and digital marketing / recruitment campaigns that specifically targeted

MDs, KOLs, and hard-to-locate patients in Orthopedics, Ophthalmology and Epilepsy and amongst others.

•Operations For (Pfizer Div. - Lederle Labs) Spearheaded design / fabrication the first computer-controlled Pharma warehouses. Helped coordinate development / rollout 1st Trivalent Polio Vax and Oncology meds.

•Hospital Planning Helped design regional merger plans for NE PA hospitals and the eventual construction of two major large medical centers in the Scranton-Wilkes Barre, PA area, post Susquehanna River flooding.

Highlights of Previous Development of Entrepreneurial Ventures:

•Owned and Developed two independent entrepreneurially-focused entities that later sold both I.P’s.

Developer of a family of MD Focused Medical Ed. Compendiums 18+ years and Med. Digital portals used as MD/KOL recruiting and marketing materials by Novartis, Pfizer, Boehringer Ingelheim, and Boots-UK.


MD Spartan Health Sciences University, El Paso, TX & St. Lucia, WI

Emphasis on Infectious Diseases / AIDS / Epidemiology All rotations completed in NYC / NJ hospitals

MBA University of Massachusetts, Amherst, MA

Health Care Marketing / Finance / Admin. w/ studies in MPH / MHA (Epidemiology / Hospital admin)

BA Boston University, Boston, Massachusetts

Genetics / Biological Anthropology / Initiated Boston’s first large-scale Tay-Sachs screening program.

Professional Experience:

First Mountain Healthcare Strategies, West Orange, NJ 2000 – Present

Medical Director: Focused currently on Strategic Projects, Alliance and Vendor Management

•Continuing to direct business outreach and projects, focusing on therapeutics, medical devices, medical systems, medical education (digital/print), and clinical trials.

•Oversaw all consulting projects, including competitive/business intel pharmaceuticals, devices, and systems. Managed healthcare B2B and B2C strategic programs, including content development, internet portals, communications, UIX development, and metrics collection.

•Evaluated and executed contract negotiations focused omnichannel marketing, market research programs.

•Developed clinical outreach strategies and corporate direction for global programs, including risk assessment.

•Implemented programs in real-world evidence (RWE), health economics and outcomes research (HEOR), patient-reported outcomes, safety, and pharmacovigilance.

•Managed complex medical alliances, medical doctors (MDs), key opinion leaders (KOLs), patient recruitment, and advisory boards.

Current & Recent Short-Term Strategic Level Consulting Projects During Covid-19 2018 - 2024

POINT B Consulting, Seattle, WA, SME & Sen Strategic Consult Clin Trials / Med. Affairs 7/23 - 2/24

For Takeda currently working as a Medical Director - SME focused on increasing the efficiency of Clin. Trials / Med Affairs and Med. Ed. initiatives. Developing in-depth analyses in support of new business initiatives for senor level corporate stakeholders on ways to change, update procedures, and streamline aspects of clinical trials, MD/KOL & patient recruitment, and Med. Education. Additionally, helping develop strategies for building interactive A.I.- driven digital clinical trial dashboards.

The Dunn Group, Totowa, NJ 6/23

Complete 360 Competitive Intelligence analysis including assessment of current and future medical value/need and Financial ROI focused on roll-out strategy, and marketing plans for a new FDA approved post M.I. cardio infusion therapy.

Reunion Neuroscience, Madison, NJ Medical Direction / Business Strategy 12/22 - 3/23 Provided medical direction and business strategy for a Phase I Clinical Trial focused on PPD (Postpartum Depression) in women. Consulted on financial strategies, trial recruitment, and safety considerations.

MedVector, El Segundo, CA 12/2022 – 3/2023

Contributed to the refinement and successful implementation of a strategy for the creation of a Hub / Spoke

Disseminated Clinical Trials venture focused on the recruitment of hard-to-reach & underserved populations.

Genome Insight, Seoul, S.K. Business / Medical Strategy Consultant 12/2022

Offered initial business and location analysis, along with implementation strategies for the US and global product localization and development. Advised on the formation of an MD Advisory Board for an international genetic sequencing company focused on precision medicine.

Gilded Financial: Middlesex, NJ (multiple projects) Start-up Strategy Consultant 5/22 - 12/22 Provided start-up strategy consulting / editorial positioning for compliance in medically focused hedge funds.

Sedulo Group, Seattle, WA (multiple assignments completed) 8/21 – 5/22 Sr. Consultant Conducted competitive intelligence analysis on emerging trends and competitors in gynecological pathology and IVD-R (In Vitro Diagnostic-Regulation) toolkits for an unnamed multinational oncology therapeutics company. Assisted in the development of a multi-specialization MD Advisory Board.

Gabriel Health, Chicago, IL (multiple assignments completed) 5/21 – 11/22 Strategic Business Development Consultant - Competitive Intelligence: Developed and implemented a sustainable CRM business model and strategic marketing campaign for US-manufactured personal protective equipment (PPE) such as nitrile gloves, gowns, shields, and other safety equipment during Covid-19 pandemic, Palo Alto, CA (multiple assignments completed) 9/20 – 4/21 Provided senior-level consulting for medical strategy, including competitive intelligence analysis.

Developed and executed marketing and business campaign models for Darcy™, an AI-based Sentinel digital technology using the Coral platform.

Engage Therapeutics (Now part of UCB Epilepsy) Summit, NJ 3/18 – 9/20 Medical Director, Alliance Management, Brand Ambassador Strategy.

Led various initiatives in medical affairs, global medical alliance management, market research, business development, and recruitment strategy for Staccato Alprazolam, a hand-held rescue inhaler for refractory epilepsy. Contributed to operational plans, patient safety, IRB management, pharmacovigilance, commercial development, competitive intelligence, digital marketing, and strategic collaborations. Assisted in Phase III planning, VA system entry strategy, and advocacy for epilepsy, & other CNS disorders.

Additional Selected Career Based Consulting Engagements with Outcomes 2000 – 2018

Elsevier's International Medical Education Division Med. Affairs: Digital Communications Strategies, Competitive Intelligence, and Medical Affairs/Med. Ed. Management Developed an oncology-focused market research program using digital medical abstracts. Created a competitive intelligence scoring system to evaluate therapeutic benefits of Celgene's oncological therapeutics and competitors' offerings.

RSI Communications: Consultant Project Director / Medical Director for Business Development Developed structural plans for competitive intelligence business / market research. Implemented a digital medical education campaign focused on regulatory compliance guidelines. Directed programs targeting consultant KOL MDs involved in pharma/device companies' clinical studies/product initiatives.

Consultant Univ. Pathology group: Design of Digital Cyto-Pathology Portal / Screening Database: Designed / promoted a digital pathology business for migrating analog pathology specimens to the web. Developed strategy and marketing plans, analyzed end-user needs, and devised migration strategy for existing databases. Enabled global pathology MDs to access annotated pathology specimens online.

CNS Therapeutics: Directed due diligence and clinical assessments. Implemented competitive intelligence, investment and market research, partnership, and clinical trial strategies. Initiated pharmacovigilance surveillance efforts for global alliances.

Schering and Merck –2x EPMO Directed / Architected - ERP, Enterprise-level scientific workstation migrations: Managed enterprise upgrade of 3500+ Macintosh scientific workstations for both Schering Plough and Merck. For Schering – Additionally, developed strategy for the development of Documentum / IBM ECM servers and modeled and then mapped the worldwide IT infrastructure using Visio.

Merck - Digital "Lab of the Future": Conducted digital needs analysis and implemented a development strategy for enterprise focused Lab Management System's software. Strengthened capacity and backbone.

Previous Medical Device Experience:

•Contributed to the technology, medical education, grants management, and global product rollout strategy for various medical devices.

•Projects include: Epilepsy delivery technologies, bone implants, intracranial drug delivery systems, OB/Gyn cervical oncology therapeutic delivery systems, auto-injectors, wound closures, sutures, staple guns, and handheld blood scanners.

•Development/Clinical Trial strategies & IVDR analysis:

•Consulted on hardware design specifications, and software for hand-held digital blood analysis devices. Advised on production costs, time to market, cooperative marketing, and 3rd party partnerships.

Respironics - Helped develop technically superior respirator masks for medical and military applications. Collaborated on the development of respirator masks for the Air Force, Navy, and Marine applications.

Publication Planning/Marketing Research Strategies: Designed and implemented digital/analog publication plans and global product omnichannel marketing research strategies. Focused on medical and direct-to consumer (DTC) audiences for a promotional medical communications company. Created slide decks and implementation plans.

The Medical Strategy Group, Montclair, NJ (< 2000)

Director of Business Development / Medical Program Director: Alliance Management

Promotional Medical Education and Clinical Program Planning projects. Development of medical and consumer utility software through long-term software consulting projects. Focused on developing and managing healthcare B2B and B2C consulting strategies.

Under a long-term contract for a leading-edge NJ based Medical Plastic Injection molding group who specialized in engineered materials for proof-of-concept product design and eventual medical fabrication.

Directed Marketing Strategy and Business Development:

•Collaborated with clients as Stryker (Howmedica, Div.), B D, J&J, Respironics, US Army, and US Navy.

•Stabilized Declining Corporate Interactions: Implemented processes to enhance corporate visibility and redefined buttressed relationships with clients affected company's stability following owner's incapacity.

•Omnichannel Marketing Strategy: Developed multiple project management initiatives, including clinical trial management, orthopedic coatings, surgical implants, Vacutainer® development, military/consumer products, and vendor/sub-contractor management.

•Implemented 9001/9004 certification process. Identified and credentialed medical/science consultants and managed contractual relationships. Responsible for Real-World Evidence (RWE)/Health Economics and Outcomes Research (HEOR), market research/outreach, and promotion.

US NAVY - Subcontractor National Medical Defense Strategy & Digital Initiative

Created and directed the development and implementation of a large, worldwide web-based Med Ed portal for secure real-time clinical and critical care management systems. Linked the program to major US Medical Centers to provide medical / surgical education and critical clinical support for US Navy ships and land-based learning for US Navy corpsmen.

BMS Digital Consultant Project Director for a large vendor Med. Ed company Morris Plains, NJ

Created an innovative, early web-based Medical Education MD portal. Designed to promote, market, and educate university-based radiologists globally on Bristol Meyers Squibb's "Prohance®" new contrast media.

Additional Related Previous Experience

Meducation International, Montclair, NJ Med. Pharma Pub. Dir. Medical Education / Bus. Development

Lederle Labs, NY (now part of Pfizer) Senior Management Engineer Pharma Develop / Polio Vaccines / Oncology Meds. (Operations, Marketing, Product Devel., Management of Systems, Manufacturing)

Health System Agency Scranton, PA. Associate Director Hospital Planning and Proposal Review

Skills - Technical:

•Medical Affairs / Compliance / PMP (Previous)

•Project Development, Analysis, Budgeting, Team Leadership, Med. Literature Pub. Review

•Marketing/ Market Research: Targeted Primary and Secondary Marketing.

•Strong experience in Behavioral Sciences, agency planning decisional / econometric modelling

•Management / Production Engineering. Finance-centric, significant Pharma / Device, GxP / ICH Drug Safety, Case and Medical Evaluations, Process scale-up

•Operations, Environmental (EPA) HazMat assessments & management, Procurement, Anti-Fraud / Security, Med Info. Systems, Epic/Cerner, C.I., EDC, ERP, CTMS, and some eTMF and GVP Module 5.

•Able to manage intracompany and inter-company stakeholders

•Software/IT: MS Suite, Project, Visio, OneNote, Teams, FileMaker/Access, InDesign, some: SAS, SharePoint, Smart Sheet, JIRA, Scrum Management, Knowledgeable Agile methods Innovative Digital Strategies, Documentum Servers

Professional Associations:

•American Epilepsy Society

•Epilepsy Therapy Project

•CURE Foundation Epilepsy Research

•Pharma Consultants Consortium NJ / PA. (PCCI)

•MAPS - Medical Affairs Professional

•NJIT Graduate School Incubator Entrepreneurial Mentoring Program.

•Summit Speech School Prior Member Board of Trustees, New Providence, New Jersey.

US Citizen Spanish – Intermediate

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