Mark Hope

Mark Hope Email and Phone Number

SVP, Head of Regulatory and Quality @ MBX Biosciences, Inc.
San Diego, CA, US
Mark Hope's Location
San Diego Metropolitan Area, United States, United States
Mark Hope's Contact Details

Mark Hope personal email

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.

Mark Hope's Current Company Details
MBX Biosciences, Inc.

Mbx Biosciences, Inc.

View
SVP, Head of Regulatory and Quality
San Diego, CA, US
Website:
mbxbio.com
Employees:
61
Mark Hope Work Experience Details
  • Mbx Biosciences, Inc.
    Svp, Head Of Regulatory And Quality
    Mbx Biosciences, Inc.
    San Diego, Ca, Us
  • Self-Employed
    Short Sabbitical For Remainder Of Year Following Transition Of Cerevel Portfolio/Team To Abbvie
    Self-Employed Nov 2024 - Present
  • Cerevel Therapeutics
    Svp, Head Of Global Regulatory And Access Solutions
    Cerevel Therapeutics Jan 2023 - Nov 2024
    North Chicago, Illinois, Us
    Senior 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.
  • Leal Therapeutics
    Chief Development And Regulatory Officer
    Leal Therapeutics 2021 - 2022
    Senior 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
  • Brazen Bio
    Senior Fellow/Strategic Advisor
    Brazen Bio Aug 2021 - Nov 2021
    Senior Fellow and member of the Faculty/Advisory Board providing strategic advice and guidance to start-up Biotech companies.
  • Ucb
    Svp, Head Of Neurodegeneration Mission At Ucb
    Ucb 2020 - 2021
    Brussels, Be
    Mission 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).
  • Ucb
    Svp, Global Head Of Tau Mission
    Ucb 2018 - 2020
    Brussels, Be
    Led 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.
  • Ucb
    Svp, Global Head Of Regulatory Affairs
    Ucb 2015 - 2018
    Brussels, Be
    Led 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.
  • Hoffmann-La Roche
    Global Head Of Neuroscience And Ad-Interim Head Of Eu/International Regulatory Affairs
    Hoffmann-La Roche 2014 - 2014
    Led 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.
  • Roche
    Global Head Of Cns And Metabolic, Regulatory Affairs
    Roche 2011 - 2014
    Switzerland 🇨🇭 , Ch
    Reported 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.
  • Roche
    Head Of Eu/Row Oncology Regulatory Affairs
    Roche 2009 - 2011
    Switzerland 🇨🇭 , Ch
    Led ~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.
  • Roche
    Head Of Program Management, Regulatory Affairs
    Roche 2007 - 2009
    Switzerland 🇨🇭 , Ch
    Accountable 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.
  • Roche
    Global Regulatory Leader And Group Leader - Virology
    Roche 2006 - 2007
    Switzerland 🇨🇭 , Ch
    Led 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.
  • Hoffmann-La Roche
    Group Director - Oncology, Regulatory Affairs
    Hoffmann-La Roche 1999 - 2006
    Oversaw 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.
  • Roche Products Ltd
    Senior Regulatory Program Manager, Regulatory Affairs
    Roche Products Ltd 1993 - 1998
  • Smithkline Beecham
    Scientific Assistant
    Smithkline Beecham 1987 - 1990
    Brentford, Middlesex, Gb
    Scientific Assistant working in Chemical Pilot Plant and part of Drug Chemical Development Group

Mark Hope Skills

Drug Development Regulatory Affairs Oncology Pharmaceutical Industry Clinical Development Clinical Trials Regulatory Submissions Ind Fda Biotechnology Nda Drug Discovery Biopharmaceuticals Life Sciences Gcp Cro Virology Regulatory Requirements Pharmacovigilance Medical Affairs Pharmacokinetics Therapeutic Areas Technology Transfer Lifesciences Ctms Translational Medicine Vaccines Pharmacology Biologics Biomarkers Infectious Diseases Glp Sop Market Access Ectd Clinical Study Design

Mark Hope Education Details

  • Stanford University Graduate School Of Business
    Stanford University Graduate School Of Business
    Stanford Executive Program (Sep)
  • Topra/University Of Cardiff
    Topra/University Of Cardiff
    Regulatory Affairs
  • University Of Nottingham
    University Of Nottingham
    Chemistry

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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