Reginera

Fractional Head of Clinical Operations & Regulatory Strategy

Accelerating Global Clinical Programs with Precision, Compliance, and Innovation

Senior clinical leadership for biotech, CROs, AI startups, and medical device companies navigating complex trial, regulatory, and operating demands.

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Strategic leadership for complex clinical programs

Fractional leadership for organizations that need executive-level discipline without permanent executive overhead.

Why Fractional Clinical Leadership?

In today's dynamic life sciences environment, organizations need senior clinical expertise without the commitment of full-time executive hires. Fractional leadership provides immediate access to decades of experience, regulatory insight, and operational excellence scaled precisely to program needs.

Whether advancing a pivotal Phase III trial, navigating complex EU MDR requirements, or integrating AI-driven clinical technologies, the right strategic partner can accelerate timelines, ensure compliance, and optimize resource allocation across global operations.

Delivering Results That Matter

From IND submissions to database lock, from site activation to regulatory inspections, every clinical milestone demands precision execution. With proven experience across 20+ years and partnerships with Bristol Myers Squibb, Merck, Pfizer, and Genentech, you gain an advisor who understands both the science and the systems.

Transform clinical complexity into competitive advantage with leadership that combines deep operational expertise, regulatory acumen, and forward-thinking innovation.

Meet Michael Adamkiewicz, MSc

Operational discipline, regulatory fluency, and AI-forward clinical strategy.

01

20+ Years of Excellence

Directing Phase I-IV clinical studies across oncology, autoimmune, infectious disease, and metabolic disorders for leading global pharmaceutical organizations.

02

Global Regulatory Expertise

IND/CTA/CTR submissions, EU MDR compliance, FDA interactions, and international frameworks across North America, Europe, and Asia-Pacific.

03

AI-Forward Mindset

UC Berkeley Haas certification in AI Strategies and Business Applications, connecting clinical operations, innovation, and compliance.

Michael partners with biotech, medtech, CRO, and digital health firms that need senior clinical leadership on a fractional or project basis, helping teams achieve faster, compliant, and data-driven results without the overhead of permanent executive placement.

Comprehensive consulting services

A five-part operating architecture for clinical execution, regulatory strategy, vendor oversight, AI adoption, and MDR readiness.

01

Clinical Operations Leadership

End-to-end global trial oversight ensuring on-time, on-budget delivery with quality excellence.

  • Strategic study planning and execution across Phase I-IV programs
  • Site identification, feasibility, and startup optimization
  • Risk-based monitoring strategy development and implementation
  • Database lock management and clinical data review
  • Cross-functional team leadership and stakeholder alignment

Strategic consulting across life sciences

Tailored expertise for organizations advancing clinical innovation through smarter, faster, and compliant operations.

Biotech & Pharma

Accelerating Phase II-III programs

Strategic operational leadership that bridges scientific innovation and regulatory requirements through pivotal trials, submissions, and inspection readiness.

CRO Partnerships

Strengthening governance and oversight

Overflow management, quality assurance audits, regulatory alignment, sponsor-CRO governance, and performance frameworks.

AI-Enabled Startups

Connecting automation with compliance

Predictive analytics, automated workflows, intelligent monitoring, and digital trial infrastructure with rigorous quality standards.

Medical Device Companies

Navigating MDR transition and market access

PMCF strategy, Clinical Evaluation Reports, post-market surveillance systems, Notified Body interaction, and technical documentation.

Proven results across global programs

Program leadership measured through scale, complexity, and execution under pressure.

0+Years Experience
0+Clinical Sites
0Top Pharma Partners
EU CTR

EU CTR Submissions

Directed successful European Clinical Trial Regulation submissions for complex fibrosis studies at Bristol Myers Squibb, achieving timely approval across multiple member states.

Phase III

Oncology Leadership

Managed KEYTRUDA Phase III global oncology trial across North America, Europe, and Asia-Pacific for Merck, coordinating hundreds of sites with exceptional data quality.

Data Lock

On-Time Database Lock

Delivered on-time database lock for Pfizer's pivotal global oncology program through risk-based monitoring and focused clinical data review.

EU MDR

MDR PMCF Development

Led PMCF protocol development under EU MDR requirements for ICU Medical, designing surveillance strategies that satisfied regulatory expectations.

What clients say

Calm leadership for clinical programs where alignment, quality, and regulatory confidence matter.

Michael brings exceptional clarity, regulatory insight, and calm leadership to complex global trials. His ability to align diverse teams across continents is unmatched.
Global Study Director, Bristol Myers Squibb
A reliable and strategic partner who understands both the science and the systems behind clinical delivery. His combination of operational expertise and strategic thinking made him invaluable.
Director, Clinical Operations, Merck

Let's accelerate your clinical milestones

Ready to transform your clinical operations?

If your organization needs immediate senior clinical or regulatory leadership to navigate complex development challenges, overcome operational bottlenecks, or accelerate critical milestones, let's connect to define the right engagement model.

Schedule a Consultation Review Services
Email michael.adamkiewicz@reginera.com Phone 510-292-7750 LinkedIn Michael Adamkiewicz