DYNE-251
Dystrophin-targeted conjugate. Completed the nonclinical package substantiating safety on the program's timeline.
IND cleared
Career record
Ten roles, two worlds, one discipline.
Eleven years inside large-pharma drug safety research, followed by functional safety leadership across five venture-backed genetic medicine companies. The full record, most recent first.
At a glance
Programs by company
DT-168
Novel trinucleotide-repeat-binding construct with no established regulatory precedent to draw on.
IND cleared — no preclinical inquiries
DT-216
Held safety and pharmacology accountability across the preclinical portfolio.
Safety & pharmacology owned
SRP-1001
Study strategy and endpoint selection through to data interpretation and internal risk position.
Nonclinical safety owned
SRP-1003
Run in parallel with AAV work, requiring separate toxicology judgement per modality.
Nonclinical safety owned
SRP-9010
Authored the preclinical safety content underpinning the program's regulatory progression.
Regulatory advancement supported
STX-001
One of four candidates on a lipid-nanoparticle mRNA platform.
IND documentation authored
STX-003
Design choices matched to both the scientific question and regulatory expectation.
GLP & non-GLP program delivered
STX-004
Platform-level safety agenda rather than candidate-by-candidate response.
GLP & non-GLP program delivered
STX-005
Submissions kept to schedule across the candidate set.
GLP & non-GLP program delivered
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Full history
Roles
Oct 2024Jul 2025
Toxicologist, Nonclinical Safety
Sarepta Therapeutics
Mixed-modality nonclinical safety across two siRNA candidates and an AAV gene therapy program.
- Held nonclinical safety ownership across SRP-1001, SRP-1003, and SRP-9010.
- Shaped study strategy and endpoint selection, then carried the work through to data interpretation and internal risk positions.
- Wrote the preclinical safety content underpinning SRP-9010's regulatory progression.
- Scrutinized contract-laboratory reports, closing gaps that would otherwise have surfaced during health-authority review.
Jun 2023Apr 2024
Senior Director, Nonclinical Safety
Strand Therapeutics
Owned the safety agenda for a lipid-nanoparticle mRNA platform spanning four development candidates.
- Planned and delivered the GLP and non-GLP program behind STX-001, STX-003, STX-004, and STX-005.
- Produced the regulatory documentation supporting IND filings and kept submissions to schedule.
- Ran cross-functional teams spanning discovery, development, and regulatory.
- Introduced operational frameworks that sharpened resource allocation against research priorities.
May 2022May 2023
Senior Director, Nonclinical Safety
Design Therapeutics
Took DT-168 through IND filing with no preclinical inquiries raised by the agency.
- Cleared the DT-168 IND with no preclinical inquiries.
- Held safety and pharmacology accountability across DT-216, DT-168, and the wider preclinical portfolio.
- Worked on novel DNA trinucleotide-repeat-binding polyamide constructs with no regulatory precedent available.
- Read toxicology data early enough to influence candidate direction before liabilities became sunk investment.
Aug 2021May 2022
Senior Director, Preclinical Development
Dyne Therapeutics
Delivered IND clearance for a dystrophin-targeted antibody-oligonucleotide conjugate.
- Completed the nonclinical package substantiating DYNE-251's safety on the timeline the program required.
- Authored the preclinical safety sections, structured for clarity under reviewer scrutiny.
- Applied conjugate-specific toxicology judgement to an interacting-liability modality.
Dec 2020Aug 2021
Director, Preclinical Safety — Project Team Lead
Novartis Institutes for BioMedical Research
Preclinical safety lead across gene therapy programs directed at neurological disease.
- Designed and executed GLP and non-GLP studies across internal laboratories and external providers.
- Wrote preclinical safety sections spanning multiple programs at differing stages of maturity.
- Acted as the preclinical voice in partnerships, keeping scientific, clinical, and regulatory stakeholders aligned.
Mar 2019Nov 2020
Senior Director, Head of Nonclinical Safety
Sarepta Therapeutics
Headed the function with full accountability for a $25M portfolio and a team of seven.
- Held accountability for a $25M portfolio centered on exon-skipping oligonucleotides and AAV delivery.
- Managed five toxicologists and two immunologists across concurrent programs.
- Set the strategy determining which liabilities were investigated, monitored, or escalated.
- Prepared nonclinical sections of INDs, NDAs, and investigator brochures, and defended positions to health authorities.
Oct 2017Jan 2019
Director, Investigative Toxicology
Pfizer
Mechanistic toxicology feeding therapeutic development decisions across the portfolio.
- Devised strategies to mitigate toxicities arising in gene therapy platforms.
- Designed nonclinical studies purpose-built to support clinical development rather than satisfy checklists.
- Evaluated and endorsed GLP and carcinogenicity study designs.
- Pursued why a toxicity occurred, not only whether it did.
Feb 2017Oct 2017
Global Molecular Pathology Lead
Pfizer
Defined mechanistic sequencing methodology and coordinated pathology across research units.
- Defined RNA sequencing methodology for mechanistic investigation.
- Coordinated molecular pathology support across multiple research units.
- Maintained regulatory compliance across Investigative Molecular Pathology Laboratory operations.
Jan 2012Feb 2017
Senior Principal Scientist
Pfizer, Inc.
Ran the Investigative Molecular Pathology Laboratory within Drug Safety Research and Development.
- Served as molecular pathology lead to the global DSRD investigative ADC team.
- Authored four lab-developed-test reports submitted to the FDA as IND amendments supporting phase 1b trials.
- Established target-expression characterization in primary tumours using western blot, qRT-PCR, ISH, and IHC.
- Confirmed absence of expression for two oncology targets, ending those programs before clinical spend.
- Implemented the RNAscope assay on automated staining instruments with Advanced Cell Diagnostics.
May 2008Dec 2011
Principal / Senior Principal Scientist
Pfizer
Early patient-selection assay development and in vitro toxicity prediction.
- Led early development of patient-selection assays for ADC programs.
- Developed in vitro models improving prediction of organ damage.
- Coordinated practice network members across sites.
