Lead discovery and development programs and provide strategic advice to advance company strategy and intellectual property.

Responsible for all toxicology programs at Kintai. Managed and coordinated all toxicology activities, budgets, and timelines in conjunction with the heads of CMC, DMPK, Clinical, and Program Management. Managed regulatory and nonclinical development strategies for discovery candidates to advance them into IND-enabling programs.

Serve as Global Early Development Lead (GED-L) for development projects (overseeing Toxicology, DMPK, Biomarker, Clinical Pharmacology and Companion Diagnostic development), primarily for biologics at this time. Management of projects in drug development beginning at exploratory development through to marketing authorization, including life cycle managment for Nonclinical Safety and GED-L. Currently developing an immunotherapy compound with novel MOA.

Provide expertise on Non-Clinical Safety (general & safety pharmacology and toxicology) and represent Non-Clinical Safety (NCS).Contribute to Program/Project Teams including appropriate NCS testing strategies in alignment with line functions, the clinical development program and the target product profile (TPP) in an environment of highly complex and international regulatory requirements, depending on product class, mode of action, therapeutic area, patient population and medical need.Analyze data/results of in silico, in vitro, in vivo studies and bibliographic data, put into strategic NCS assessments.Contribute to the safe administration of development compounds and prepare recommendations for decision by relevant governance bodies; between decision points, analyze new NCD/NCS relevant information, foresee impact on project and program strategyEnsure appropriate content and format of NCS parts of all regulatory relevant documents including Investigator Brochures, IMPD/INDS, global marketing authorization applications (e.g. BLA/NDA) and other filings in compliance with current regulatory requirements, global and internal standards.Represent Non-Clinical Development within Program/Project Teams as NCD-Leader (NCD-L)and facilitate provision of high quality expertise on DMPK, and biomarker technology including testing strategies, strategically oversee contributions of other NCD representatives on the program and act as multilateral interface between PT-Leaders, NCD team members, NCDline functions and NCD management, and other functions.Contribute to in- and out-licensing activities

Providing expertise and management of all aspects of preclinical drug development. I can assist in strategic development, design, implementation, and oversight of preclinical, IND enabling toxicology programs, ADME, and efficacy work associated with small molecule, protein-based, and RNAi drug development. Expertise in indications such as cancer, metabolic, neurodegenerative and immunologic diseases. I also have significant experience in evaluation of drug development opportunities for companies involved in due diligence and partnering activities (acquisition or out-licensing). Also available to support with development of nonclinical portions of regulatory filings in support of INDs, IMPDs, BLAs, IBs and other technical regulatory documents

Providing comprehensive preclinical support for Acucela's ocular therapies in glaucoma, dry eye, and macular degeneration. In addition, heading up an early stage in-house research effort capitalizing on Acucela's unique knowledge in ocular drug development.

Provide expertise in toxicology and ADME from early lead optimization through phase 3 and registration. Responsible for the design, implementation, and oversight of preclinical, IND enabling toxicology programs as well as support for ADME and efficacy work associated with small molecule and protein-based drug development. Significant expertise in evaluation of drug development opportunities for companies involved in licensing and drug development partnering activities (acquisition or out-licensing).Assistance with REACH implementation, training, toxicology evaluation, and IUCLID also available for clients in the chemical industry.

Responsible for the design and oversight of contracted drug safety studies (primarily oncology therapeutics) performed in support of clinical trials and for facilitating the progression of clinical development plans. Participate in the preparation of Investigational New Drug applications, clinical investigator brochures, and other regulatory documents. Responsibilities also include working closely on Product Development Teams with individuals from Clinical, Manufacturing, Quality Control, Chemistry and Regulatory Affairs in order to meet corporate drug development goals. Other responsibilities also include a role as an in-house toxicology/ADME expert on interdisciplinary teams involved in evaluating potential in-licensing opportunities and drug collaborations with other biopharmaceutical companies. Participation to date includes evaluation of over 60 companies, with ~10 resulting in comprehensive due diligence investigations.

Responsible for directing nonclinical studies in the areas of acute, subchronic, and chronic toxicology. Duties included the overall technical conduct of the study, as well as the analysis, interpretation, documentation, and reporting of the results. Compound experience includes antibodies, small molecule, natural products, cosmetic ingredients, localized gene therapy, and protein therapeutics. Substantantial experience with all routes of exposure (oral, dermal, subcutaneous, IV) with a particular emphasis in parenteral drugs.

Project manager for one of AMUR's proprietary drug development projects. This included the design and supervision of toxicology and efficacy studies for compounds including implementation of a telemetric analysis system for cardiac and blood pressure assessment in rats. Also managed laboratory resources and directly supervised four research associates.