Open to opportunities

KittyKat User

@kittykatuser

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I am a Clinical Pharmacology leader driving model-informed drug development and regulatory success.

United States

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What I'm looking for

I seek leadership roles in clinical pharmacology or pharmaceutics to apply MIDD and regulatory strategy, mentor teams, and accelerate drug development in a collaborative, risk-aware environment.

I am a Clinical Pharmacology leader with 16+ years advancing small molecules, biologics, and fixed dose combination development across oncology, virology, immunology, metabolic diseases, and rare diseases.

I have a proven track record from pre-IND to NDA submission, with expertise in dose selection, PK/PD strategy, regulatory submissions, and cross-functional leadership. I have authored CTD content and led Clinical Pharmacology submission packages and global regulatory responses.

I am hands-on with advanced modeling and software including NONMEM and Phoenix NLME, and routinely perform popPK, exposure–response, NCA and PK/PD modeling using WinNonlin, R-GUI, S-PLUS and Berkeley Madonna. I have built internal capability through training, courses, and collaborative model development.

I combine technical rigor with strategic judgment honed by six years as an entrepreneurial commodity trader, applying resilience, risk-based decision-making and big-picture planning to accelerate development, reduce program cost, and deliver regulatory-ready documents.

Experience

Work history, roles, and key accomplishments

Current

Associate Director, Clinical Pharmacology

Current

Servier

Mar 2023 - Present (2 years 5 months)

Led Clinical Pharmacology submission for Japan J-NDA, authoring CTD Modules 2.7.1/2.7.2 and coordinating RtQ responses and meetings with PMDA; authored global Clinical Pharmacology responses for FDA, EMA, MHRA, Swissmedic, CDE and ANVISA. Serving as Clinical Pharmacology lead for China CTA planning and Phase III bridging strategy.

Clinical Pharmacology Regulatory Submissions PK PD Strategy RtQ Responses NONMEM Phoenix NLME

Independent Strategist – Commodity Trading

Yulin Heritage LLC

Feb 2017 - Feb 2023 (6 years)

Built and managed an entrepreneurial commodity trading business, applying advanced risk assessment, scenario planning, and strategic patience to navigate volatile markets and inform high-stakes decision-making. Developed frameworks for uncertainty tolerance and risk-based judgment transferable to pharmaceutical program strategy.

Risk Management Strategic Planning Trading Strategic Decision Frameworks Risk Based Judgment

Associate Director, Clinical Pharmacology

Bristol-Myers Squibb

Jan 2010 - Jan 2017 (7 years)

Led Clinical Pharmacology for T2DM, NASH, obesity and fibrotic disease programs across small molecules, biologics and an FDC, designing and executing over 20 clinical protocols and guiding PK/PD and MIDD strategy through post-marketing commitments. Prepared regulatory documents (IB, IND, CTD, CCDS) and performed hands-on population PK and exposure–response analyses.

Pharmacometrics Population PK NONMEM Phoenix NLME Regulatory Submissions

Principal Scientist, Clinical PK/PD

Boehringer Ingelheim

Jan 2004 - Jan 2010 (6 years)

Provided Clinical PK leadership for virology and immunology programs from preclinical transition through early clinical phases, advancing antiviral programs to Phase II and leading data analysis and study document standardization across sites. Designed PoM and Phase 0 studies to inform go/no-go decisions and biomarker strategies.

Clinical Pharmacology Biomarker Strategies Drug Development Regulatory Interactions