
Mary Ann Lumiqued
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Mary Ann Lumiqued
- Current 3 years and 11 months, since Jul 2022
Vice President Program Management
Tubulis GmbH
Program Management Global Head responsible for advancing the development plans of Tubulis’ emerging antibody drug conjugate (ADC) pipeline by working with the various functions (Preclinical, Biomarker, CMC, Quality, Clinical) to effectively strategize, plan, and execute on the multiple oncology programs from development candidate selection, clinical development, regulatory submission and approvals, and commercial launch.
- 1 year and 9 months, Oct 2020 - Jun 2022MorphoSys AG
Global Medical Affairs - Head of Project Strategy and Operations
Responsible for developing and executing the process for the Medical Affairs strategy and tactical plans. Lead MA operations in close partnership with the leadership team, and drive alignment among external and internal partners in R&D and Commercial. Develop and execute the process for the medical strategy for MONJUVI/ tafasitamab, felzartamab, and future products.
Program Leader for MONJUVI / tafasitamab, the first FDA approved product within organization. Also with multiple trials ongoing and planned in Phase 1, 2 and 3 to treat B-cell malignancies including Diffuse Large B-Cell lymphoma, Follicular Lymphoma and Chronic Lymphocytic Leukemia. Lead cross-functional Global Program Team and Working Groups to develop, implement and achieve the overall program strategy and project objectives.
- 2 years and 4 months, May 2012 - Aug 2014
Director, Development Project Management
Acorda Therapeutics
• Led Core Teams of two commercial products to advance the overall strategy of the brands. Liaised among Upper Management, Teams and business partners to ensure corporate and team goals are achieved. • Directed operational teams supporting the various lifecycle management and development programs to ensure activities aligned with the internal strategy. • Drove cross-functional teams to produce the Strategic Plans, Integrated Development Plans, Target Product Profiles and Executive Summaries.
- 2010 - 2012
Senior Manager, Business Planning and Analytics
Ipsen
• Established cross-functional commercial teams for the therapeutic area groups with focus on thorough planning and more appropriate coordination and communication within and across products and functions, and between the U.S. Affiliate and headquarters. • With teams, developed and executed the strategic and annual tactical plans comprised of budgets, forecasts, timelines and key performance indicators (KPIs). • Managed Canadian partnership with EMD Serono.
- 2008 - 2010
Associate Director, Project Management
Oxigene
• Initiated, implemented and maintained the project management discipline within organization. Presented strategy and updates to Senior Management and Board. Managed program reviews with strategic drug development partner. • Led cross-functional Teams for drug candidates in Phases 1-3. Identified critical path activities and implemented mitigation strategies. • Developed Target Product Profiles utilized for strategic portfolio analyses.
- 2001 - 2008
Senior Manager, Program Management
Anesiva (formerly Corgentech)
• Led, managed and facilitated multiple cross-functional meetings (Core, CMC, Clinical-Regulatory, Launch, Device and Pre-Approval Inspection) for drug and drug-device programs in all phases of development. Core Team co-lead for company’s first approved product. • Designed and improved project management systems throughout the organization: risk mitigation and contingency planning, project opportunity assessments, lessons learned, go/no-go decision points. • Managed alliance with Bristol-Myers Squibb.
- 1998 - 2000
Lab Assistant III
Univ of CA, San Francisco: Dept of Preventive & Restorative Dental Sciences
• Supported lead scientists, postdoctoral fellows and graduate students with experiments and programs related to dental research.
- 1997 - 1998
Research Assistant
The Salk Institute: Peptide Biology Lab
• Conducted research (how stress and alcohol affect the brain) and gathered data required for final analysis. • Taught and managed part time students performing experiments.
Program Leader in the Biopharmaceutical Industry
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Detail-oriented Biopharmaceutical Project Management Professional (PMP) with over 20 years of experience leading drug and drug/device combination programs in all phases of development (Preclinical, Clinical, BLA/NDA/PMA/510(k) Filing, Approval) and commercialization (launch, lifecycle management). Experience in Oncology (solid tumors and haematology-oncology), Neurology, Endocrinology, Ophthalmology, Pain Management, Inflammation and Cardiovascular disease
Ausbildung von Mary Ann Lumiqued
- 2002 - 2003
Biotechnology Management: Emphasis in Project and Program Management
University of California, Santa Cruz Extension
- 3 years and 10 months, Sep 1993 - Jun 1997
Physiology and Neuroscience
University of California, San Diego
Biology, Psychology
Sprachen
English
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