Valerie Cullen

Senior Vice President, Head of Research and Translational Science

2024 - Current

Senior Vice President, Research

2021 - 2023

Head of research across three sites, responsible for all biology and translation efforts across three disclosed programs and other exploratory projects. Built research capabilities, oversaw assay development, and incorporated molecular pharmacology, biomarker discovery/omics and bio-informatics. Key team member during $80M Series B raise. Recruited and re-launched new SAB. Strategic thought partner to BD function regarding competitive landscape, scientific differentiation and partnering. Early stage clinical planning and TPP design.

Vice President, Translation & Development

2019 - 2021

Recruited as employee # 2, reporting to the CEO. Crafted and communicated the scientific vision during Series B fundraising, pharma diligence/collaboration activities, Scientific Advisory Board presentations and Board of Directors meetings. Drove all aspects of pharmacology and translational medicine for two programs focused on harnessing E3 ligase biology to target TFEB (autophagy) and AMPK (metabolism and energetics). Close collaborator for ADME, PK, CMC, toxicology regulatory filings and clinical planning.

Vice President, Program and Alliance Management

2017 - 2019

Member of executive leadership team, reporting to CEO. Program Lead and Program Manager for company’s lead program, a GCase allosteric modulator for Parkinson's Disease. Oversaw the integration of research, translational medicine, non-clinical safety/toxicology, CMC, clinical development and operations, regulatory affairs. Alliance manager with pharma partner and member of Joint Development Committee. Managed alliance from DC declaration through IND-enabling studies, CMC scale up, SAD/MAD and Phase 2a clinical development. Shaped strategy, drove decisions and monitored large R&D budget. Led on-time delivery of Development Data Package.

Senior Director, Translational Medicine and Program Management

2016 - 2017

Program Manager and lead for GCase program. Additionally, managed all translational medicine aspects of the program. Identified and collaborated with CRO partners for genetic, biomarker and PK testing in Phase 1 SAD/MAD and Phase 2a studies. Liaison and relationship management with key external parties: patient foundations, KOLs, clinicians, geneticists, advocacy group. Primary author for scientific portions of Investigator Brochure, Clinical Study Protocols, and Clinical Study Reports. Program updates to Board of Directors, leadership team, partner.

Director, Scientific Affairs

2014 - 2016

Director of Scientific Affairs at Aldeyra Therapeutics, a publicly-traded company with a novel aldehyde trapping technology platform. Broad portfolio managing preclinical and translational research in a number of neurological, inflammatory and dermatological indications, including those in the orphan disease space. Scientific, clinical and market analysis to support overall corporate planning and strategy setting. Engagement of multiple stakeholders including KOLs, academic partners, clinical investigators, patient foundations and executive team.

Independent Consultant

2014 - 2016

Provided expert consulting support on target biology and preclinical pharmacology for innovative biotech company. Managed key external relationships, designed and submitted grant proposals, reviewed regulatory documents, provided technical guidance on assay/biomarker development.

Associate Director, Preclinical R&D

2012 - 2014

Key member of Alzheimer’s and Parkinson’s Disease preclinical team and program Leader for all non-AD/PD research. Company leveraged bacteriophage biology to treat diseases of protein aggregation, raising over $110M to develop novel IgG-fusion proteins with specificity for amyloid beta sheets. Collaborated with academic groups and CROs to concept, design and execute preclinical efficacy studies: ALS, Huntington’s Disease, prion disease, TTR and AL amyloidosis. Built relationships with KOLs, foundations and patient groups (Prize 4 Life, ALS TDI, CJD Foundation, Amyloidosis Foundation). Integrated clinical and business factors with scientific strategy; guided decision-making for choice of therapeutic indication; advised executive team and board members on all aspects of programs. Two programs advanced to clinic: Alzheimer’s Disease, Light Chain Amyloidosis.

Independent Consultant

2012 - 2012

In depth consulting and project management services in a biotech setting.

Senior Scientist II

2010 - 2011

Senior Scientist

2007 - 2009

Senior scientist at innovative start-up company, conducting and leading studies aimed at small molecule drug development for neurodegenerative disease. Responsibilities include: conception, design and execution of in-house mechanistic studies; on-boarding of new technology/assay development; management of externally conducted in vivo studies including study design, vendor selection and liaison, budgeting, close-out; pharmacodynamic aspects and novel biomarker identification and validation; commisioning of consulting agreements; liaision with management team and scientific committee of board of directors re project proposals and strategy.