Professional Summary
Shane McGann is a seasoned leader in the pharmaceutical industry, currently serving as the Vice President and Head of Regulatory Affairs at Mythic Therapeutics, Inc. in Boston, Massachusetts. With over a decade of experience in regulatory strategy and management, he is an expert in navigating the complex regulatory landscape, particularly in the areas of oncology and skeletal dysplasias.
Professional Experience
Vice President, Head of Regulatory Affairs | Mythic Therapeutics, Inc. (2023-01-01 to Present)
- Oversee all regulatory affairs activities, ensuring compliance with global regulations and guidelines
- Develop and implement regulatory strategies to support the company's pipeline of innovative therapies
- Collaborate cross-functionally with research, clinical, and manufacturing teams to optimize regulatory submissions
- Serve as a key member of the executive leadership team, providing strategic guidance on regulatory matters
Senior Director, Head of Regulatory Affairs Strategy, Oncology & Skeletal Dysplasias | BridgeBio (2022-06-01 to 2023-01-01)
- Spearheaded the development and execution of regulatory strategies for the company's oncology and skeletal dysplasia drug candidates
- Managed a team of regulatory affairs professionals to ensure timely and successful regulatory submissions
- Partnered with clinical, scientific, and commercial teams to align on regulatory requirements and milestones
Associate Director, Regulatory Affairs | Agios Pharmaceuticals (2019-10-01 to 2021-03-01)
- Provided regulatory expertise and support for the company's oncology portfolio, including leading the successful submission and approval of a new drug application
- Collaborated with cross-functional teams to develop and implement regulatory strategies
- Mentored junior regulatory affairs professionals, contributing to the growth and development of the team
Academic Background
Shane holds a Ph.D. in Pharmaceutical Sciences from the University of Massachusetts Amherst, where he specialized in regulatory affairs and drug development. His academic achievements include several peer-reviewed publications and presentations at industry conferences.
Areas of Expertise
- Regulatory strategy and compliance
- Oncology and skeletal dysplasia drug development
- Global regulatory submissions and approvals
- Cross-functional team leadership and collaboration
- Mentorship and professional development
Professional Impact
Shane's expertise and strategic leadership have contributed to the successful advancement of multiple drug candidates through the regulatory process. His industry contributions include serving on the Board of Trustees at Albany College of Pharmacy and Health Sciences, where he provides valuable insights and guidance to the next generation of pharmaceutical professionals.
Conclusion
With his extensive regulatory affairs experience, proven track record of success, and deep industry knowledge, Shane McGann is a valuable asset to Mythic Therapeutics, Inc. and the broader pharmaceutical industry. He is well-positioned to continue driving the company's regulatory strategy and contributing to the development of innovative therapies that improve patient outcomes.
