building sustainable future for LIFE-SCIENCE ventures

Summary

MONIKA ROGOZINSKA
Entrepreneurship is the pursuit of opportunity beyond resources controlled - Professor Howard Stevenson, Harvard Business School.
Senior life science executive with solid business acumen and entrepreneurial expertise. Creates and advances global drug and CDx development strategies for the USA, Europe, China, Japan until and beyond commercial launch through product lifecycle management. Manages operations, complex R&D portfolios, and strategic alliances with Fortune 500 pharma and small biotech companies. Accountable for pre-revenue P&L forecasting and $500M annual budget management. Builds and quickly scales up organizations with less than 5 to up to 300 employees. Demonstrated capabilities in contract negotiations, implementation of international opportunities and technologies. Advises start-ups on optimizing and achieving maximum results with minimum time, effort, expense, or risk.

Timeline

  1. -
    Strategic Advisor, Life-Sciences, Startup Organizations
  2. -
    Board Member, Peer Health Exchange

    Boston's Board & Development Committee Member

  3. -
    Advanced Certificate for Executives , Massachusetts Institute of Technology
  4. -
    SVP & Chief Development Officer, Adial Pharamceuticals
  5. Clinical Pharmacology & Therapeutics Article

    Author of "Can the Use of Novel Digital Devices Improve the Productivity of Drug Development?", Clinical Pharmacology & Therapeutics
    DOI: 10.1002/cpt.989

    http://onlinelibrary.wiley.com/doi/10.1002/cpt.989/abstract

  6. -
    General Management Program/EMBA alternative, Harvard Business School
  7. -
    VP, Consulting, Clinical Programs & Portfolio, ECRC LLC (consulting company)
  8. -
    Program Executive, Bavencio®, ImmunoOncology, Merck
  9. -
    Director, Clinical Project Management, Pfizer

Skills (YEARS)

  • clinical development
    20+
  • R&D strategy & OPS
    20+
  • GLOBAL REGULATORY AFFAIRS
    20+
  • alliance & VENDOR management
    20+
  • Oncology & RARE DISEASE
    15
  • change management
    15
  • COmmercial & BIZ Dev
    15
  • Risk MANAGEMENt
    15
  • product Life cycle management
    15
  • P&L, BUDGETS
    15
  • Project Management
    18
  • program management
    15
  • Portfolio MANAGEMENT
    12
  • Medical devices, CDx
    15

VALUE PROPOSITION

What do I bring to the table?

*Operational & Strategic Expertise*
As a Chief Development Officer at Adial Pharmaceuticals and Program Executive at Merck KGAa, I built business operation & product strategies, reporting structures, and governance frameworks. I advance global drug & device development strategies, applying best-in-class life science practices.

*Global Regulatory & Risk Proficiency*
I am adept in assessing the risks and effects of global drug development regulations directives and laws (Europe, USA, China, Japan) that may impact the organization or the relevant operating environment, both positively and negatively. I led product development in North and South America, Europe, Australia, and Asia.

*Competence in Defining R&D Vision and Goals to Foster Innovation*
I have expertise in defining and formulating the organization's fundamental values, purpose, and drivers and translating vision and goals to inspirational and effective strategies.

*Change & Growth Leadership*
I led Pfizer's, Merck's, and Adial's teams through rapid scale-up and change. I identified internal change agents and championed new approaches to strategy and execution. I managed research-oriented organizations to commercial product launches.

Proudest Accomplishment

Development and commercial launch of Bavencio® under 4 years from IND

Experience Highlights

  • Global Drug and Medical Devices Development & Commercialization
    Europe, China, Japan, USA
  • Portfolio, Program and Project Management
  • Formation and Management of Strategic Partnerships
  • R&D Operational Models & Governance
  • Change Management & Organizational Transformation
  • Life-Science Startups
    biotech, MedTech, pharma
  • For-Profit and Nonprofit Fundrising

Education Highlights

  • Massachusetts Institute of Technology
    -Advanced Certificate for Executives in Management, Innovation, and Technology (ACE)
  • Harvard Business School‎
    -General Management Program (GMP24)
  • Harvard Business School Executive Education
    -Foundation of private equity and venture capital
  • Harvard Business School Executive Education
    -SucceEding as a corporate director
  • Project Management Institute
    -Project Management Professional (PMP®)
  • Nicolaus Copernicus University, Collegium Medicum, Poland
    -Master of Science (MSc), Laboratory Medicine

Causes

  • I support following organizations:
    Peer Health Exchange

MEMBERSHIP

  • Harvard Business School Association of Boston (Alumni)
  • HBS Angels of Boston (Angel Investors)
  • Harvard Alumni Entrepreneurs
  • MIT Club of Boston (Alumni)
  • MIT Technology Review Global Panel
  • Tomouh Community of Leaders (TCL)
  • American College of Corporate Directors
  • Project Management Institute