Melanie Gloria
Thousand Oaks,CA
Overview
22
22
years of professional experience
Work History
Chief Operating Officer
ACELYRIN
11.2021 - Current
- Supported company build from inception to current state (R&D portfolio with early, mid, and late stage assets and employee base of ~145 people)
- Led in partnership with CFO multiple rounds of corporate financing inclusive of a $540M IPO
- Developed and led corporate and portfolio governance to ensure robust decision making
- Led development of corporate values, tenets, and culture
- Oversaw day-to-day operations across multiple departments. Functional responsibilities included oversight of Facilities, IT, CMC, Clinical Operations, Biometrics, Regulatory, PV, Project and Portfolio Management, Quality and Compliance
- Developed talent and recruitment strategy to support growing portfolio and recruitment of top talent to deliver high quality clinical development programs
- Played a critical role in mergers and acquisitions activities; including due diligence processes, negotiations, integration planning, and execution efforts to ensure seamless transitions.
Senior Vice President, Development Operations
Horizon Therapeutics
07.2018 - 10.2021
- Responsible for global oversight of clinical operations, pharmacovigilance, regulatory, project management and R&D compliance and standards
- Responsible for oversight and execution of Phase 1-4 clinical studies across therapeutic areas
- Drove the strategy and implementation of the expansion of responsible functions within R&D
- Reported directly to the CEO and represented R&D on Executive Team/Board Meetings
- Drove efficient approaches to planning and implementing operations leveraging technology
- Oversaw overall R&D budget and finances
- Responsible for resource planning and management
- Oversaw and fostered strategic partnerships with key alliance partners
- Developed procedures to ensure compliance with regulations and oversaw successful global regulatory inspections.
Senior Director Strategic Clinical Operations
AbbVie
11.2017 - 07.2018
- Provided oversight for a global organization of over 450 employees responsible for Compliance, Standards, Vendor Management, Training, Medical Writing, Safety Management, and Document Management Functions
- Accountable for driving continuous improvement to achieve globally efficient and cost-effective operations
- Provided strategic direction and maintains oversight of the GCP Quality System used by all AbbVie personnel in the conduct of GCP activities
- Ensured alignment with global and local regulatory requirements across all countries operating clinical trials [60+ countries]
- Responsible for people growth and development.
Director/Senior Director Clinical Program Development
AbbVie
08.2014 - 11.2017
- Provided strategic leadership and direction to the Clinical Program Development, a global organization operating clinical studies in 60+ countries and with a staff of 275+ employees and contractors in multiple countries around the world
- Responsible for on-time within budget delivery of clinical programs across Immunology, Virology, and General Medicine Therapeutic Areas
- Oversaw 4 NDA/MAA filings for New Molecular Entities and 10 sNDAs/supplemental indications for established products
- Led the team through successful regulatory inspections globally
- Responsible for people growth and development.
Several Positions With Increasing Responsibility
Abbott Laboratories/AbbVie
04.2002 - 08.2014
Education
Bachelor's of Science - Nursing -
University of Illinois, Chicago
05.1999
Skills
- Executive Leadership
- Operations Management
- Cross-Functional Teamwork
- Strategic Planning
- Process Improvement
- Contract Negotiation
- Performance Management
- Financial Management
- Corporate Communications
- Organizational Development
- Recruitment and retention
- Change Management
Awards
- 2019- Crain's Notable Women in Health Care Awardee
- 2021 - Pharma Voice 100 of the Most Inspiring People; Change Agent Category
Timeline
Chief Operating Officer
ACELYRIN
11.2021 - Current
Senior Vice President, Development Operations
Horizon Therapeutics
07.2018 - 10.2021
Senior Director Strategic Clinical Operations
AbbVie
11.2017 - 07.2018
Director/Senior Director Clinical Program Development
AbbVie
08.2014 - 11.2017
Several Positions With Increasing Responsibility
Abbott Laboratories/AbbVie
04.2002 - 08.2014
Bachelor's of Science - Nursing -
University of Illinois, Chicago
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