PIR International supports appointment of VP Regulatory Affairs at Gilgamesh Pharmaceuticals
Gilgamesh Pharmaceuticals is a US headquartered clinical-stage neuroscience biotech founded in 2019 by a highly accomplished team with deep expertise across leading biopharma companies, successful venture-backed startups, and top-tier academic institutions. The company is a clinical-stage neuroscience biotech developing innovative, best-in-class new chemical entities (NCEs) that transform the treatment paradigm of psychiatric diseases, moving away from symptom management towards rapid-acting and durable therapies.
Leveraging world-class medicinal chemistry capabilities alongside an advanced AI-enabled discovery and translational platform, Gilgamesh has built a highly differentiated pipeline. This includes its lead clinical programme, GM-1020, currently in Phase 2 clinical development for Major Depressive Disorder (MDD), as well as several high-potential preclinical assets. The company’s scientific strength and strategic value were further validated by the $1.2 billion sale of its clinical asset GM-2505 to AbbVie, an ongoing collaboration with AbbVie to develop next-generation neuroplastogen candidates, and a grant from National Institute on Drug Abuse (NIDA) to advance ibogaine analog engineered NCES to avoid cardiovascular safety liabilities. Together, these milestones reinforce Gilgamesh’s position as a leading innovator in the resurgence of precision psychiatry.
As Gilgamesh continues to advance its pipeline through critical clinical milestones, the company recognised the need to strengthen its regulatory leadership with a senior executive capable of operating effectively in a fast-paced, growth-stage biotech environment. Gilgamesh partnered with PIR International to identify an accomplished Vice President of Regulatory Affairs with the expertise, strategic insight, and adaptability to design and execute global regulatory strategies. The successful candidate would bring a proven track record of leading regulatory submissions, engaging directly with the FDA, and navigating complex regulatory pathways across multiple development programmes.
Following a comprehensive, US-centric search led by Tom Bradley, Stuart Penney, and Robaya Akter, PIR International successfully appointed Bridget Walton, MS, RAC (DRSc cand.) into this pivotal leadership role. The appointment represents a critical addition to Gilgamesh’s executive team, bringing high-impact regulatory expertise at a time of significant momentum for the business. With strong visibility internally and across the broader industry, the role is positioned to play a meaningful part in shaping Gilgamesh’s future success and accelerating the delivery of transformational psychiatric therapies to patients.
Comment from Jorge Quiroz, MD MBA, Chief Strategy & Development Officer, Gilgamesh Pharmaceuticals:
As Gilgamesh enters its next phase of growth, strengthening our regulatory leadership was a strategic priority. Bridget brings the experience, judgment, and executional rigor required to guide multiple programs through global regulatory interactions and position the company for long-term success. Thank you to Tom and Stuart for steering a highly collaborative, professional and efficient process.
Comment from Bridget Walton, VP Regulatory Affairs, Gilgamesh Pharmaceuticals:
I am excited to join Gilgamesh at such a pivotal time. The company’s differentiated science and commitment to transforming psychiatric care present a unique opportunity to build thoughtful, forward-looking regulatory strategies that can efficiently advance these promising therapies to patients.
