Dr. Frank Gary Renshaw

Dr. Frank Gary Renshaw

Clinical Development Lead; Consultant (fractional)

About

Doctor of Osteopathic Medicine, board-certified in Internal Medicine, Oncology, and Hematology, with active medical licensure in Michigan, Texas, Pennsylvania, West Virginia, New Jersey, and New York. Over two decades of pharmaceutical oncology and hematology drug development experience, with leadership in more than a dozen successful NDAs and over 30 INDs and EMA first-in-human submissions.Passionate about building high-performing clinical organizations and advancing transformative oncology therapiesTherapeutic Focus Areas:Breast cancer, ovarian cancer, colorectal cancer, NSCLC, hepatocellular carcinoma, pancreatic cancer, soft tissue sarcoma, multiple myeloma, and gastrointestinal cancers.Track record includes:12+ NDAs and global registration25+ successful IND submissions (US & EMA)Global Leadership of FIH, proof-of-concept, and Phase III programsExperience across solid tumors, hematologic malignancies, non malignant heme and internal medicine, immunology, cell therapy and targeted agentsFormer CMO and Head Clinical Development with deep expertise in;Early Development strategy and logisticsClinical pharmacology and translational medicineRegulatory submission and DSUR oversightProgram rescue and lifecycle optimizationData integrity and patient safety governanceCurrently leading clinical development at Mirror Biopharma, advancing T-cell therapy programs in Colorectal cancer and immuno-oncology as well as focusing on Phase I/Phase II drug development at Radyus Research (both fractional positions). Open to additional fractional positions or full time opportunities.

Country

United States

City

Greater Philadelphia

Industry

Biotechnology

Skill

Oncology Clinical Research, Clinical Study Design, Clinical Strategy, Trial Management, Regulatory Compliance, Global Drug Development, Global Regulatory Compliance, Clinical Research, Clinical Operations, Executive Management, Leadership, Strategic Planning, Statistical Data Analysis, Online Lead Generation, Business Strategy, Medical Writing, Pharmaceuticals, Biopharmaceuticals, Requirements Analysis, Pharmaceutical Sales

Experience

Radyus Research

Clinical Development Lead; Consultant (fractional)

Radyus Research

2026-4 - Present · 6 mos

Atlanta, GA

Mirror Biologics, Inc.

Consultant

Mirror Biologics, Inc.

LinkedIn
2024-9 - Present · 2 yrs 1 mo

United States

clinical study oversight, Strategic planning for current and future studies. Business development

Mirror Biologics, Inc.

Senior Medical Director

Mirror Biologics, Inc.

LinkedIn
2024-9 - Present · 2 yrs 1 mo

United States

Helix Biopharma Corp.

Chief Medical Officer

Helix Biopharma Corp.

LinkedIn
2019-12 - 2025-10 · 5 yrs 11 mos

Wayne, PA

Study review and publication, presentations at International conferences, Study design, onset, logistics, safety and efficacy review, pharmacology, pharmakinetics Business development

Bayer

Global Pharmacology Leader

Bayer

LinkedIn
2012-6 - 2018-11 · 6 yrs 6 mos

United States

Clinical pharmacology Lead in US and EU, Phase I and post marketing studies for full approval Global clinical lead for Xofigo, Copanlisib, and Regorafenib Clinical studies, pharmacology and regulatory submission

Education

Rowan University School of Osteopathic Medicine

Rowan University School of Osteopathic Medicine

LinkedIn

Medicine

1981-8 - 1985-5 · 3 yrs 10 mos

Dr. Frank Gary Renshaw's Contact Information

Email

******@***.com

Phone

(**) *** ****

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