Elizabeth Wagner

Biopharma operations, clinical development, and corporate development executive with 20+ years leading the full arc of early-stage drug development (from protocol strategy and hands-on trial delivery to deal execution and Board-level governance) across peptide, large- and small-molecule, and cell-therapy organizations spanning rare disease, cardiovascular, neurology, and oncology indications. As the senior-most operator at lean, founder-stage companies (including three simultaneously at Tarix), has built governance structures, quality/SOP frameworks, program-management functions, and vendor ecosystems from scratch, and has personally made real-time clinical, quality, and regulatory judgment calls across the trial lifecycle. Direct experience spans clinical operations (multi-region trial execution, CRO/vendor governance, inspection readiness), regulatory strategy (FDA, EMA, Israel MOH engagement; 5+ ODDs, 3 RPDDs, INTERACT/PIND/IND filings), corporate and business development (a $30M out-licensing deal, BD evaluation from $10M–$200M), and program/portfolio governance (decision-ready dashboards and stage-gate cadences for CEOs and Boards).

MIT MBA/MS, thesis on biopharmaceutical portfolio risk; former MIT Lecturer; PMP in progress (exam scheduled Oct 2026).

Interim Chief Operating Officer and Advisor — Cell therapy company, rare metabolic disorders at Glafabra Therapeutics (2025-05 – Present)

• Serve as strategic thought partner and operational lead to the executive team for a rare metabolic disease, IND-enabling cell-based gene therapy program moving toward first-in-human execution, making day-to-day calls on protocol, regulatory, and vendor issues.
• Led Orphan Drug Designation strategy and submission (granted Mar 2026); directed FDA engagement planning, including an INTERACT briefing document and RPDD request, translating complex disease biology and regulatory data into decision-ready recommendations for leadership.
• Built program tracking tools, dashboards, and governance-ready reporting giving leadership real-time visibility into milestones, risk, and resourcing across a matrixed organization; directed cross-functional alignment of the CDMO/CRO/site vendor ecosystem on scope, budget, and timeline.
• Built board- and investor-ready strategic materials and led fundraising and diligence meetings with VCs and strategic partners in support of capital-raising decisions, the BD/alliance counterpart to the program's operational execution.

President — Fractional/interim strategic operations, program management, and clinical operations consultancy at Crestline Therapeutics Consulting (2024-10 – Present)

• Serve as fractional/interim advisor to multiple biotech and pharma companies concurrently on integrated program planning, clinical operations, CRO/vendor governance, regulatory strategy, and corporate-development activities.

Chief Operating Officer / VP, Program Management and Development at Constant Therapeutics, LLC (2017-01 – 2024-10)

• Served as the integrated-portfolio owner and governance lead for a peptide/small-molecule portfolio spanning chronic stroke (cardiovascular), DMD cardiomyopathy (neuromuscular/cardiology), and Epidermolysis Bullosa (rare/orphan disease) — directing CMC/manufacturing, clinical, and regulatory functions and external partners around shared milestones, budget, and risk.
• Directed development planning and execution for 3 Phase 2-ready assets and 2 initiated Phase 2 trials conducted in Israel, personally signing off on monitoring plans, risk assessment and mitigation plans (RAMPs), and protocol deviations, and resolving protocol interpretation, safety, and vendor issues that exceeded study-team resolution.
• Led corporate development execution behind a $30M out-licensing deal for a small-molecule asset: quarterbacked cross-functional diligence, built the data package, and prepared deal and strategy materials for governance-level and VC-acquirer review.
• Directed regulatory strategy for 5 Orphan Drug Designations, 2 Rare Pediatric Disease Designations, 1 IND, and 2 Israel MOH filings; built quality and regulatory governance processes from scratch, including CSR generation and protocol development oversight, ensuring GCP compliance and inspection readiness across the portfolio.
• Directed the company's pandemic pivot, standing up 3 investigator-initiated COVID-19 studies, including a 510-patient NIH-sponsored trial, while maintaining continued execution and scientific/regulatory rigor across the existing portfolio.
• Secured $850K in non-dilutive funding from a coalition of patient organizations for Epidermolysis Bullosa, building and managing a multi-stakeholder relationship; advanced an oral peptide formulation through GMP production, coordinating CMC, clinical, and regulatory input.
• Recruited, trained, and mentored the program-management, clinical operations, consultant, and vendor-management team supporting the portfolio; partnered with Finance on budget planning, forecasting, and investment prioritization.

Chief Operating Officer / VP, Development at Tarix Pharmaceuticals, Tarix Orphan & TarixCVM (2011-10 – 2016-12)

• Directed clinical development strategy, operations, and regulatory administration (manufacturing, preclinical/clinical, and regulatory) across three lean (3–5 person) companies simultaneously as a founding operational leader, personally building SOPs, governance, and quality standards from scratch for each entity.
• Led PIND and IND regulatory strategy for FDA submission in Duchenne muscular dystrophy (a neuromuscular/neurology indication); led close-out for 3 oncology studies spanning cord blood and peripheral blood transplant patients with leukemia, lymphoma, or myeloma.
• Led preclinical scientific evaluation of a NASH (hepatic) asset, directing the data review and go/no-go analysis that informed the decision not to advance the program into clinical development.
• Recruited, led, and coached a team of consultants and vendor representatives from scratch; performed business development activities including valuation modeling and authored grant applications for non-dilutive financing.

Vice President, Corporate Development at Pathfinder Cell Therapy, Inc. (2011-10 – 2016-12)

• Led corporate development for an early-stage cell therapy technology: assessed commercial potential through primary/secondary market research and financial analysis, negotiated contracts, and optimized IP positions with academic research partners — direct in-licensing and alliance-management experience at the discovery stage.
• Built cash-flow analyses and strategic documents that directly informed company and portfolio strategy and investor conversations.

Lecturer, Biomedical Enterprise at Massachusetts Institute of Technology (2014-01 – 2017-12)

• Taught a biomedical engineering seminar for ~45 PhD students, redesigning curriculum each semester across medical/research ethics, biomedical business, global health, and health policy; designed varied learning formats (guest lectures, case studies, role-play simulations) for cross-disciplinary audiences.

Clinical Research Associate II (promoted from CRA I/Coordinator) at Genzyme Corporation (2004-06 – 2008-07)

• Monitored 10 clinical research sites across 3 Phase 1 studies with a clinical pharmacology focus, including a Parkinson's disease trial, alongside idiopathic pulmonary fibrosis and ITP studies — making real-time site-level judgment calls on dosing compliance, safety data, and protocol adherence.
• Developed the initiation plan for an international Phase II study and oversaw close-out of a large Phase III pivotal study for rare/orphan-disease enzyme replacement therapy.
• Selected to serve on an 8-member Global Harmonization Team that standardized 32 investigational product document databases, reducing redundancies and increasing productivity organization-wide; trained 16 international physicians and 9 study coordinators on electronic diary systems.
• Represented a 150-person U.S. clinical research department on a 5-member FDAAA 2007 Task Force assessing the impact of regulatory change on all active and future trials.

Corporate Development Intern at Cubist Pharmaceuticals (2011 – 2011)

• Evaluated $10M–$200M BD deals; developed an emerging-markets growth strategy.

MBA Summer Intern, Pipeline & Portfolio Planning at Genentech (2010 – 2010)

• Built a portfolio-overview framework for senior leadership review; analyzed portfolio risk and recommended follow-on studies.

MBA Summer Intern, Commercial Leadership at Amgen (2009 – 2009)

• Led sales-strategy analyses informing a $2M investment decision.

Part-time Associate at CBT Advisors (2008 – 2010)

• Supported a biotech start-up investor pitch and conference-facing materials.

MBA; MS – Massachusetts Institute of Technology — MIT Sloan / Harvard-MIT Division of Health Sciences & Technology (2011)

MA in Clinical Investigation – Boston University (2003 – 2006)

BS in Pre-Medicine – University of Notre Dame (1998 – 2002)