Theresa Matkovits, Ph.D.

Theresa Matkovits, Ph.D. Email and Phone Number

Chief Development Officer @ Kaléo
New York, NY, US
Theresa Matkovits, Ph.D.'s Location
New York City Metropolitan Area, United States
Theresa Matkovits, Ph.D.'s Contact Details

Theresa Matkovits, Ph.D. work email

Theresa Matkovits, Ph.D. personal email

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About Theresa Matkovits, Ph.D.

I am a C-Suite Business Leader and Board Director with extensive experience building global multinational pharmaceutical, mid-size, and small biotech companies. I have proven success in developing global programs, leading all phases of drug development through commercialization, and successfully negotiating with the FDA and global health authorities.Additionally, I have significant board experience advising both publicly traded and private companies in healthcare.Executive Highlights Include:► Global development head, leading the successful build-out, growth, and management of global drug development organizations and portfolios as COO and CDO across several therapeutic areas and companies including Endocrine Disorders, Cardiovascular, Anti-infectives, Antivirals, Central Nervous System Disorders, Women’s Health, as well as a number of orphan indications.► Commercial success leading global development for approved and registered products – Orbactiv, Natpara, Clozaril, Fanapt, and Valdoxan – and late-stage products including biologics, small molecules, and devices. Additionally, co-led building, staffing, and operationalizing NPS Pharma International commercial organization in US, EU, Japan, and Latin America to support the approval and launch of Revestive and Natpara/Natpar.► Deep regulatory expertise working with regulatory bodies worldwide, including FDA, EMA (European Union), C-FDA (China), PMDA (Japan), and health authorities in India and Australia. Led NPS through a successful Advisory Committee Meeting with the FDA which was pivotal to the $5.2B acquisition of NPS by Shire.► Selected member of the inaugural class of Women in Bio/GW University Boardroom Ready Program.► Serve as the face of companies with investors/potential investors, Board of Directors, regulatory authorities, analysts, potential partners, and clinicians, translating/communicating value story, corporate strategy, and clinical data.

Theresa Matkovits, Ph.D.'s Current Company Details
Kaléo

Kaléo

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Chief Development Officer
New York, NY, US
Theresa Matkovits, Ph.D. Work Experience Details
  • Kaléo
    Chief Development Officer
    Kaléo
    New York, Ny, Us
  • Kaléo
    Chief Development Officer
    Kaléo Oct 2024 - Present
    Virginia, United States
  • Goodcap Pharmaceuticals Inc.
    Chairperson Of The Board
    Goodcap Pharmaceuticals Inc. Jan 2022 - Present
    Board Director, Compensation Governance Committee Member for life sciences company delivering psilocybin-based therapeutics.
  • Appili Therapeutics
    Lead Independent Board Director
    Appili Therapeutics Oct 2018 - Present
    Halifax, Nova Scotia
    Lead Independent Board Director; Audit Committee Member; Chair of Compensation, Governance and Nominating Committee for Canadian biotech company.
  • Biosurplus
    Independent Director
    Biosurplus Jan 2017 - Present
    Greater San Diego Area
    Board Director for a leading provider of pre-owned laboratory instruments and equipment management services.
  • Matinas Biopharma
    Chief Development Officer
    Matinas Biopharma Oct 2018 - Oct 2024
    Bedminster, Nj
    Brought on as Chief Development Officer to drive the development of clinical-stage portfolio for public, biopharmaceutical company developing a proprietary drug-delivery platform targeting treatment of infectious diseases, inflammation, and oncology areas. Serve as the clinical face of the company to investor community including banks, Analysts, and Life Science Investors, delivering clinical and scientific perspectives on value proposition of portfolio.
  • Aradigm Corporation
    Board Director
    Aradigm Corporation Jun 2018 - Feb 2019
  • Contravir Pharmaceuticals, Inc.
    Chief Operating Officer
    Contravir Pharmaceuticals, Inc. Dec 2017 - Oct 2018
    Member of the ContraVir Executive Team, establishing and building out a global development organization and highly successful clinical-stage Antiviral portfolio. Represented ContraVir to key internal/external stakeholders – ContraVir Board of Directors, Health Authorities, Analysts, Investors, Bankers, potential partners, and Clinicians – translating and communicating ContraVir’s value story, corporate strategy, and clinical data.Built and oversaw +50% of the company including Clinical Development, Regulatory Affairs, Pharmaceutical Development & Manufacturing, Quality, and Program Management. Realized $10M in savings and 3 years in development time across two programs.Led successful negotiation with FDA of a 505(b)2 accelerated and streamlined regulatory pathway for Tenofovir Exaledex (TXL) and accelerated Phase 2 development pathway for CRV431.
  • Contravir Pharmaceuticals, Inc.
    Executive Vice President, Head Of Drug Development
    Contravir Pharmaceuticals, Inc. May 2015 - Oct 2018
  • Center Point Clinical Services Llc
    Board Member
    Center Point Clinical Services Llc Nov 2016 - Jan 2017
  • Nps Pharmaceuticals
    Research & Development Program Leader
    Nps Pharmaceuticals Feb 2014 - May 2015
    Recruited to serve as Global Team Leader for this rare disease-focused biotech company to lead two programs through successful FDA approval and commercialization.Led integration of two commercial assets acquired from Takeda into NPS, partnering with CEO and Chief Commercial Officer to drive NPS international expansion into 4 major markets – EU, Japan, Canada, and Latin America.Led development team to secure positive FDA Advisory Committee vote and subsequent approval of the BLA for Natpara, pivotal to Shire’s $5.2B acquisition of NPS Pharma (Jan 2015). Selected as R&D lead for Shire/NPS Integration Team.
  • Matkovits Enterprises, Llc
    President And Founder
    Matkovits Enterprises, Llc Mar 2013 - Feb 2014
    New Jersey
    Pharmaceutical Executive providing leadership, strategic, and operational global pharmaceutical support and services to biotech and pharmaceutical client base.
  • Matkovits Enterprises, Llc
    President And Founder
    Matkovits Enterprises, Llc Mar 2013 - Feb 2014
  • The Medicines Company
    Vice President, Innovation Leader Infectious Disease
    The Medicines Company Oct 2010 - Mar 2013
    Joined as co-lead of Global Infectious Diseases Business Franchise. Drove development and execution of compound strategy for a marketed novel Anti-Infective (Orbactiv). Led strategy, recruited senior leadership, built teams, and executed operational infrastructure – Clinical, Regulatory, Toxicology, and Product Management.Formulated business case to support pricing, integrated marketing, and reimbursement strategies for Orbactive, maximizing the value of the asset as member of the Commercial Launch Team.Delivered positive Phase 3 results ahead of schedule, within budget, contributing significant shareholder value with first-pass approval of NDA by FDA and EMA.
  • Novartis
    Executive Director, Head Strategic Planning And Operations
    Novartis Sep 1997 - Oct 2010
    Managed $250M budget, led team of 80, and oversaw all US products excluding Oncology, providing strategic direction and execution for all Phase 2-4 compounds and in-line brands within the General Medicines portfolio. Led a department of 50+ associates, including 7 direct reports.Developed Skill Center of Excellence for Risk Evaluation and Mitigation Strategies (REMS) and Plans. | Established Compliance function within US Medical and Drug Regulatory Affairs. | Led development of Organizational Development & Learning Strategies, building “best-in-class” US Clinical Development, Medical Affairs & Regulatory Affairs organizations.Responsible for driving Annual Strategic Brand Planning Process in US Medical and DRA, ensuring robust aligned Medical Brand Plans developed, maximizing brand value for payors, regulators, and customers, driving top-line growth.
  • Organon Pharmaceuticals
    Clinical Research Scientist
    Organon Pharmaceuticals 1994 - 1997
    Responsible for running clinical studies in the profertility, osteoporosis, and anesthesia product.

Theresa Matkovits, Ph.D. Education Details

Frequently Asked Questions about Theresa Matkovits, Ph.D.

What company does Theresa Matkovits, Ph.D. work for?

Theresa Matkovits, Ph.D. works for Kaléo

What is Theresa Matkovits, Ph.D.'s role at the current company?

Theresa Matkovits, Ph.D.'s current role is Chief Development Officer.

What is Theresa Matkovits, Ph.D.'s email address?

Theresa Matkovits, Ph.D.'s email address is tm****@****rma.com

What schools did Theresa Matkovits, Ph.D. attend?

Theresa Matkovits, Ph.D. attended University Of Medicine And Dentistry Of New Jersey -New Jersey Medical School, Alfred University.

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