Lynn D. Email & Phone Number

Bridgewater Nj

Contribute to a multi-disciplinary effort to design, supervise, and interpret toxicity studies, and prepare written reports and summaries for regulatory submissions (including IND's, MAAs, CTXs, and NDA's); 2) serve as Project Team Representive on small molecule and biotherapeutic Project Teams, as needed, and design and coordinate the nonclinical safety programs for drugs in development; 3) participate in PCS Department research activities, special projects or inter-industry working groups, as needed; 4)mentor other PCS personnel and provide scientific advice and recommendations to PCS management; 5) evaluate external opportunities from the nonclinical perspective, as needed, and 6) serve as internal expert for scientific issues related to nonclinical safety issues.Part of multidisciplinary team responsible for the development and registration of avalglucosidase alfa (Pompe Disease) and Aubagio (Multiple Sclerosis).

Bridgewater, Nj

Director, Toxicology, DSAR-PS, sanofi, Bridgewater NJ.

Bridgewater, Nj

Dedicated Project Expert, MS DPU, Sanofi-Aventis, Bridgewater NJ. Provided dedicated preclinical safety expertise to the Multiple Sclerosis (MS) DPU by contributing to designing programs, issue resolution, innovation, and performance. Support the MS DPU in internal meetings as well as meetings with regulatory agencies, IRB, etc. Support due diligence efforts. Support other Units as required.

Bridgewater, Nj

Associate Director, Toxicology, DSE Projects (US), Sanofi-Aventis, Bridgewater NJ. Supervise two PhD Toxicologists. DSE Project Team Representative on early and late stage project teams. Prepare technical summaries and address Regulatory Authority comments relating to applications. Toxicology Study Director.

Collegeville, Pa And Bridgewater, Nj

Lead Research Investigator, Drug Safety Evaluation, Sanofi-Aventis / Aventis / Rhone-Poulenc Rorer, Bridgewater NJ / Collegeville PA. Toxicology Lead (manager) of two PhD Toxicologists and mentor of a third PhD safety pharmacologist. Project Team Leader on CNS and respiratory development compounds. DSE Project Team Representative on early and late stage project teams. Prepare technical summaries and address Regulatory Authority comments relating to applications. Study Director and Study Monitor on GLP and non-GLP toxicity studies.

Malvern, Pa

Principal Research Investigator, Toxicology, Sanofi Research / Sanofi Winthrop / Sterling Winthrop, Malvern PA / Collegeville PA. Supervisor of Report Writing Group and Toxicology Archives. Study Director on GLP and non-GLP toxicity studies. Toxicology Project Team Representative on multiple development project teams. Prepared technical summaries and position papers. Addressed Regulatory Authority comments relating to applications.

Collegeville, Pa

Senior Research Investigator, Safety and Experimental Toxicology, Sterling Winthrop / Sanofi Winthrop, Collegeville, PA. Study Director on GLP and non-GLP toxicity studies. Toxicology Team Representative on multiple development project teams. Prepared technical summaries and position papers.

Spring House, Pa

Scientist / Senior Scientist, Drug Safety Evaluation, R.W.J. Pharmaceutical Research Institute, Spring House, PA. Study Director on GLP and non-GLP toxicity studies. Developed models for continuous intravenous infusion in rats and dogs, and active systemic and passive cutaneous analyphylaxis testing in guinea pigs. Toxicology Team Representative on multiple discovery and development project teams. Supervised full-time technicians and co-op students. Prepared technical summaries for submissions. Prepared MSDSs. Reviewed and evaluated in-license candidates. Prepared numerous position papers on excipients and contaminants.