Mark Hope Email and Phone Number
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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.
Mbx Biosciences, Inc.
View- Website:
- mbxbio.com
- Employees:
- 61
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Svp, Head Of Regulatory And QualityMbx Biosciences, Inc.San Diego, Ca, Us -
Short Sabbitical For Remainder Of Year Following Transition Of Cerevel Portfolio/Team To AbbvieSelf-Employed Nov 2024 - Present
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Svp, Head Of Global Regulatory And Access SolutionsCerevel Therapeutics Jan 2023 - Nov 2024North Chicago, Illinois, UsSenior Executive accountable for ensuring successful delivery of early and late phase assets to patients combined with broader Enterprise level leadership. - Lead organizational preparedness for upcoming late phase pipeline and NDA filings. - Lead global Regulatory and Value and Access function ensuring delivery of high quality regulatory and access/reimbursement strategies. - Provide enterprise level advice, input and decision making as member of executive governance and decision committees. - Provide senior leadership and mentoring across the company at all levels. - Establish and manage key external partnerships, including Health Authorities and external partners. - Further develop and build Regulatory and Value and Access function and individuals into world class organization with strong focus on people and leadership development. -
Chief Development And Regulatory OfficerLeal Therapeutics 2021 - 2022Senior Executive and C-Suite /Leadership Team member accountable for clinical development and regulatory strategy and delivery. - Provide senior leadership, advice and mentoring across the company at all levels - Establish and manage key external partnerships, including Health Authorities and CROs - Design and deliver FIH clinical development and regulatory strategy and plans - Advise on requirements and build plans for future IND submission -
Senior Fellow/Strategic AdvisorBrazen Bio Aug 2021 - Nov 2021Senior Fellow and member of the Faculty/Advisory Board providing strategic advice and guidance to start-up Biotech companies. -
Svp, Head Of Neurodegeneration Mission At UcbUcb 2020 - 2021Brussels, BeMission Head with expanded accountability for different products in varying stages of development, commercialization, and global brand management for an in-market asset of ~€350M in revenue. Led team of 70-100 FTEs. Managed multimillion-dollar budget, in-market neurodegeneration assets, and implementation leadership of future corporate strategy. - Delivered against plan for Phase I/II asset, completing study, CMC development, and scale up on time / budget; implemented market access, go-to-market, and launch excellence strategies. Projected to achieve multibillion-dollar revenue impact. - Led cross-organizational team in developing / implementing future neurodegeneration and gene therapy strategies (5-10 years). -
Svp, Global Head Of Tau MissionUcb 2018 - 2020Brussels, BeLed Mission / Mission Core Leadership Team for key therapeutic assets with oversight and accountability for all asset and sub-team deliverables: development, approval, market / commercial, patient access, technical development, and alliance management, with each sub-team leader as a direct report. Recruited key talent into Mission Leadership. - Transitioned from Early Solutions to Neurology Business Unit; recruited and built high-performing Mission Leadership team and implemented / delivered development plans according to time and cost. - Implemented next step in clinical development program, CMC development, scale-up, and Medical / Coms plans. -
Svp, Global Head Of Regulatory AffairsUcb 2015 - 2018Brussels, BeLed team of ~200, accountable for global regulatory deliverables across value chain and ~€40M budget (Therapeutic Global Heads, Regulatory Policy and Intelligence, APAC / Japan Regional Heads, CMC Regulatory, Regulatory Operational Excellence). Representative on governance and review committees – early / late-stage portfolio, Benefit Risk Board, Development and Medical Practice Leadership.- Led and implemented a significant organizational redesign within the Regulatory function, including hiring and placement of key regulatory leadership team positions. - Strengthened and expanded global regulatory function, focusing on Japan and China, resulting in successful filings and approval of 2 major assets in China and Japan. - Designed and led corporate-wide initiative on implementing a New Development Paradigm, delivering patient solutions through innovation; reduced time and cost and maximized probability of successful differentiation and patient value. -
Global Head Of Neuroscience And Ad-Interim Head Of Eu/International Regulatory AffairsHoffmann-La Roche 2014 - 2014Led global team up to 80 accountable for Neuroscience portfolio products (Neurodegeneration, Neurodevelopmental, Psychiatry; franchise heads, global regulatory leaders, US / EU regulatory partners, program managers). Ensured deliverables were met across CNS product portfolio (strategic input into projects teams, filings, Health Authority interaction management). - Delivered a strong EU affiliate network; strengthened intelligence and policy team by leading EU / International Regulatory Group (45 FTEs) comprised of Emerging Markets Regulatory Affairs, EU / International Clinical Trials, EU Regulatory Intelligence / Policy. - Ensured appropriate consideration of regulatory needs and balanced time, cost, and risk as representative and member on Global Regulatory Leadership team and several portfolio, governance, and review committees within therapeutic area.
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Global Head Of Cns And Metabolic, Regulatory AffairsRoche 2011 - 2014Switzerland 🇨🇭 , ChReported to Global Head of PDR. Led team of ~45 people with responsibility for CNS and CV / Metabolism product portfolio. • Built and implemented new team / organizational design. • Implemented and completed regulatory deliverables (CTA filings, HA interactions), ensuring on-time initiation and completion of number of clinical assets across entire value chain. -
Head Of Eu/Row Oncology Regulatory AffairsRoche 2009 - 2011Switzerland 🇨🇭 , ChLed ~55 regulatory staff with responsibility for portfolio of oncology and virology products. Ensured regulatory deliverables were met and provided strategic advice to regulatory program managers. Ensured strong talent development and growth. Achieved key approvals for new MAAs/line extensions, including Herceptin, Avastin, and Tarceva. -
Head Of Program Management, Regulatory AffairsRoche 2007 - 2009Switzerland 🇨🇭 , ChAccountable for ~35-40 program management staff working across portfolio within various therapeutic areas. Ensured regulatory strategic input into development programs, regulatory filings, license maintenance, and people / performance management and development. -
Global Regulatory Leader And Group Leader - VirologyRoche 2006 - 2007Switzerland 🇨🇭 , ChLed group of program managers (GRLs, EU Partners) across virology projects inc. Tamiflu and Pegasys. Global Regulatory Lead for Tamiflu during intensive period of product lifecycle (FDA Pediatric Advisory Committee and intensive Health Authority interactions with Japanese PMDA and MHLW). Directed ~25 managers across 4 program management groups covering oncology and CNS. -
Group Director - Oncology, Regulatory AffairsHoffmann-La Roche 1999 - 2006Oversaw US / global regulatory strategy and implementation for various products, IND and NDA filings, maintenance, and FDA interactions. Directed orphan drug applications, advisory committee participation, due diligence, and advertising and promotional review. Managed oncology product portfolio, leading program managers US Partners, and GRLs; mentored / guided projects, general line management, goal setting, and performance, achieving filings and approvals, including for Boniva.
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Senior Regulatory Program Manager, Regulatory AffairsRoche Products Ltd 1993 - 1998
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Scientific AssistantSmithkline Beecham 1987 - 1990Brentford, Middlesex, GbScientific Assistant working in Chemical Pilot Plant and part of Drug Chemical Development Group
Mark Hope Skills
Mark Hope Education Details
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Stanford University Graduate School Of BusinessStanford Executive Program (Sep) -
Topra/University Of CardiffRegulatory Affairs -
University Of NottinghamChemistry
Frequently Asked Questions about Mark Hope
What company does Mark Hope work for?
Mark Hope works for Mbx Biosciences, Inc.
What is Mark Hope's role at the current company?
Mark Hope's current role is SVP, Head of Regulatory and Quality.
What is Mark Hope's email address?
Mark Hope's email address is ma****@****ucb.com
What schools did Mark Hope attend?
Mark Hope attended Stanford University Graduate School Of Business, Topra/university Of Cardiff, University Of Nottingham.
What skills is Mark Hope known for?
Mark Hope has skills like Drug Development, Regulatory Affairs, Oncology, Pharmaceutical Industry, Clinical Development, Clinical Trials, Regulatory Submissions, Ind, Fda, Biotechnology, Nda, Drug Discovery.
Who are Mark Hope's colleagues?
Mark Hope's colleagues are Sarah Swanson, Tiffany Dombrosky, Stephen Sullivan, Austin Bongen, Cpm, Angela Merkley, Christine Bach, Piotr A. Mroz, Phd.
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