Monika Rogozinska's Workfolio

Monika Rogozinska's WorkfolioMonika Rogozinska's WorkfolioMonika Rogozinska's Workfolio
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Monika Rogozinska's Workfolio

Monika Rogozinska's WorkfolioMonika Rogozinska's WorkfolioMonika Rogozinska's Workfolio
  • Professional Workfolio
  • Explore & Engage
  • Contact
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Welcome!

Welcome to my professional webpage, where I showcase my professional journey and connect with like-minded individuals in the pharmaceutical and biotechnology industry. Here, you'll discover insights into my background, accomplishments, and aspirations, fostering meaningful connections and opportunities.

About Monika Rogozinska

Professional Profile

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, and 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 $250M annual budget management. Demonstrated capabilities in contract negotiations and implementation of international opportunities and technologies. Advises start-ups on optimizing their portfolio strategies to achieve commercial product launches with minimum time, effort, expense, and risk. Builds and quickly scales up organizations with less than 5 to up to 300 employees.

Connect on Linkedin

Industry Experience

Monika has worked for a variety of companies in the pharmaceutical and biotechnology industries, ranging from large Fortune 500 corporations to small startups. Her extensive experience has provided her with a unique perspective on the dynamic and transformative nature of this field. Monika is enthusiastic about sharing her knowledge and experience with you, inviting you to explore the diverse tapestry of this ever-evolving landscape alongside her.

Core Competencies

  • R&D Leadership: As the Chief Development Officer at Adial Pharmaceuticals and VP of Pipeline and Programs at Dynamicure Biotechnology, Monika has consistently demonstrated effective leadership in shaping business operations and driving R&D initiatives. She has successfully developed robust pipeline and product strategies, established efficient reporting structures, and implemented effective governance frameworks to ensure organizational success.


  • Global Regulatory & Risk Management: Monika possesses extensive expertise in assessing the risks and implications of global drug development regulations, directives, and laws across key regions, including Europe, USA, China, and Japan. Her keen ability to navigate and anticipate regulatory requirements positively impacts organizational operations and fosters compliance in diverse operating environments. Monika has led successful product development efforts across North and South America, Europe, Australia, and Asia.


  • R&D Vision & Innovation: With a deep understanding of the industry, Monika excels in defining an organization's core values, purpose, and drivers, setting a visionary R&D path. She formulates and executes strategies that inspire innovation, driving sustainable growth and positioning the organization at the forefront of advancements in the field.


  • Change & Growth Leadership: Throughout her accomplished career at Pfizer, Merck, and Adial, Monika has consistently showcased effective leadership in leading teams through periods of rapid scale-up and change. She adeptly identifies internal change agents and champions new approaches to drive organizational growth. Monika's leadership has successfully guided research-oriented organizations through the transition from R&D to commercial product launches, fostering a culture of innovation and propelling growth.

Notable Achievements

  • Created a center of excellence for project management at DynamiCure Biotechnology, which implemented innovative practices that resulted in significant improvements in efficiency and effectiveness.
  • Joined a pre-IPO pharma company and built the entire operation & product development strategies from the ground up, including hiring personnel, creating reporting structures, and establishing governance bodies. Contributed to the S1 filing, which led to a successful IPO (NASDAQ: ADIL).
  • Single-handedly developed and executed strategic plans to solve regulatory hurdles and maintain the submission timelines and goals, which led to the successful start of a pivotal study of leading Adial's ph3 asset.
  • Led the Bavencio® (avelumab, anti-PD-L1) team through Pfizer's due diligence process, which resulted in a $2.85 billion worth alliance with Pfizer to develop jointly and market avelumab (recognized by Licensing Executives Society Deals-of-Distinction-Award).
  • At Merck KGAa, developed jointly with Pfizer, clinical development and operational plans, which led to 30 ongoing clinical programs and nine pivotal studies with investigational anti-PD-L1 (avelumab), with approximately 2,200 patients being treated across more than 15 tumor types. Led team until BLA filing, concluded with the commercial launch of Bavencio® in March 2017, just four years after the first IND. It was Merck's first successful product commercialization in 10 years.
  • Managed a significant scaleup (personnel growth from 35 to 300 in 1.5 years).
  • Led the program strategy and supported the operations team for the timely 2015 start of 6 phase 3 in 2015 & 11 studies in total (=300% increase in the number of projects for Merck Pharma).
  • Achieved the dose selection within seven months, PoC in 17 months, and first phase 3 start in 25 months from FIH first subject in (Merck 2015 CEO's award winner for unprecedented speed).
  • Led Merck's development team during a due diligence process resulting in obtaining $200M in financing from private equity firms and strategic investors.
  • At ECRC LLC, led due diligence on the clinical and pre-clinical molecules for a VC company leading to several successful transactions in the biotechnology sector.
  • Accountable for pre-revenue P&L forecasting and budget management. Managed R&D program budgets up to $250 mln/year within a 1% variance.

Advisory Boards Service

Advisory for Startup Accelerators

Monika is a passionate advisor to startups, and has been fortunate to work with two innovative accelerators: Creatella Impact and ReachBack.


Creatella Impact (NYC, Singapore)

Creatella Impact is a non-profit accelerator that provides early-stage social enterprises with the resources and support they need to scale their impact. Monika has been an advisor to Creatella Impact for the past three years, working closely with some amazing entrepreneurs who are dedicated to solving some of the world's most pressing problems.


ReachBack (Atlanta)

ReachBack Inc,  is an entrepreneurial, experiential learning pre-seed accelerator that provides business and professional training. Monika has been an advisor to ReachBack Inc for the past two years, collaborating with exceptional entrepreneurs who are dedicated to building successful businesses

Education and Interests

Monika is a dynamic professional who combines expertise in science with a deep understanding of business and innovation. With a Master's degree in Laboratory Medicine from Nicolaus Copernicus University in Poland, Monika possesses a strong scientific foundation. She further enhanced her skills through the General Management Program (GMP) at Harvard Business School, an extensive executive program that granted her alumni status, connecting her to a global network of accomplished professionals.


Monika's commitment to continuous learning is exemplified by completing prestigious programs that have broadened her expertise across different areas. She successfully completed the Advanced Certificate for Executives in Management, Innovation, and Technology (ACE) at MIT, another comprehensive program that provided her with a deeper understanding of management, innovation, and technology. This program also conferred upon her alumni status, allowing her to tap into a vast network of innovators and thought leaders.


Building upon her foundation in science and business, Monika pursued specialized programs to expand her skill set. She completed the Venture Capital and Private Equity program at Harvard Business School, followed by the Early Startup Investments program at Columbia University, focusing on angel investing and early-stage startups. Additionally, Monika honed her expertise in mergers and acquisitions through the M&A program at Columbia University. To complement her strategic abilities, she also completed the Sales program at Kellogg School of Management, equipping her with the necessary skills to excel in sales and drive business growth.


Her interdisciplinary knowledge spans diverse areas, including blockchain, digital business strategy, and data monetization, positioning her at the forefront of innovation. Monika excels in bridging the gap between science and business, envisioning and implementing cutting-edge solutions.


Discover more about Monika's expertise and how she can contribute to your organization's success by visiting her LinkedIn page.

In the News

Adial Pharmaceuticals (NASDAQ: ADIL): Achievements and Milestones

Press release, Jan 9, 2020

Adial Pharmaceuticals Receives Approval to Commence Phase 3 Trial.

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Press release, Sep 25, 2019

Adial Provides Update on Clinical Activities; Filing to Commence Phase 3 Trial on Track for Q3 2019.

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Press release, Nov 14, 2018

Adial Pharmaceuticals Provides Business Update for the Third Quarter of 2018.

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Press release, Aug 15, 2018

Adial Pharmaceuticals Announces Appointment of Monika Rogozinska as Senior Vice President of Drug and Business Development.

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Monika Rogozinska's Resume

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Monika Rogozinska

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