Verified recordBiotechnology Research

Mark Hope

SVP, Head of Regulatory and Quality at Mbx Biosciences, Inc

Based in United States

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Seniority

Director

Department

Other

Location

United States

Industry

Biotechnology Research

Company size

91

Contact information

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Email

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m•••••••@mbxbio.com

Phone

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Background

About Mark Hope

A dynamic global pharma and asset leader, well-respected for leadership, EQ-IQ balance, drug development, and regulatory across various therapeutic areas, with notable focus in Neurology, Immunology, CV-Metabolism, and Oncology- Delivers patient and organizational value through innovative drug development and efficient go-to-market strategy, balancing time, cost, and quality- Maximizes patient outcomes and experiences, focusing on innovation and evolving ecosystem through demonstrated strategic agility and entrepreneurial spirit- Encourages people and talent growth and performance improvement, achieving consistently high employee engagement scores- Natural curiosity for new trends, technology, and approaches; develops an inspirational mission that aligns and motivates employee base to ensure delivery of high patient value.Product Development | Regulatory | Asset Management & StrategyOrganizational Design | Team Development & Leadership | Business AcumenCAREER HIGHLIGHTS- Head of Neurodegeneration Mission, part of the Neurology business unit reporting into Neurology Patient Value Unit Head/EXCOM member, accountable for development of 1 late phase asset and brand management of 1 in-market asset. Successfully led development of corporate cross-functional strategies in Neurodegeneration and Gene Therapy- Global Head of Regulatory with accountability and oversight for all regions including US, EU, China, and Japan- Proven track record across entire regulatory and drug development value chain, including INDs / CTAs, NDA / MAA filings and approvals, and FDA / EMA Advisory Committees- Hands-on experience of US and EU / ROW regions with assignments in the UK, US, Switzerland, and Belgium; extensive experience with global health authorities. various therapeutic areas, with notable focus in Neurology, Immunology, CV-Metabolism, and Oncology.Graduate of the Stanford Executive MBA Program (SEP) 2018.

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