Pharmaceutical Non-clinical R&D Leader with proven track record as a drug hunter in a major global pharmaceutical organization. Expertise in toxicology and drug metabolism / pharmacokinetics delivered as a project team member and as a senior functional manager to projects from early discovery through worldwide regulatory submissions and product defense. Dynamic leader who has built new departments,
Pharmaceutical Non-clinical R&D Leader with proven track record as a drug hunter in a major global pharmaceutical organization. Expertise in toxicology and drug metabolism / pharmacokinetics delivered as a project team member and as a senior functional manager to projects from early discovery through worldwide regulatory submissions and product defense. Dynamic leader who has built new departments, and also maintained motivation and productivity of staff during periods of restructuring and significant change
• Built integrated, multi-disciplinary department that reduced safety-related attrition of candidate drugs through use of novel technologies and screening cascades
• DMPK representative on project team that applied pk/pd to develop and register new oncology product in
Quantitative Pharmacology and Drug Disposition (QPD) Project Representative @ Represent the QPD department on project teams from discovery through late stage development, and due diligence activities. Responsible for writing the PK sections of the NDA/MAA dossier for a Phase 3 oncology project, and the coordination and integration of the nonclinical activities and regulatory document preparation by the experts from the 2 companies responsible for the joint development of this project. From August 2013 to Present (2 years 5 months) Principal @ • Preparation of Pharmacokinetics, Safety Pharmacology and Toxicology sections of INDs and IBs for clients
• Project team representative for non-clinical sciences. Coordinate outsourcing of nonclinical studies (DMPK, Bioanalysis, Safety Pharmacology, Toxicology)
• SAB member for startup company developing novel platform for early safety screen From February 2013 to Present (2 years 11 months) Greater Boston AreaPharmaceutical Non-clinical R&D Expert @ Have intimate knowledge of drug discovery and development processes via previous experience as a functional project team representative from drug metabolism and toxicology.
Experienced member of multiple management, project and scientific governance and review bodies focused on quality underpinning decreased safety-related attrition
Hardworking and enthusiastic scientist/project team rep/manager/leader with passion for innovative problem solving From August 2012 to July 2013 (1 year) Global Head, Safety Assessment Operations @ • Implemented new toxicology and safety pharmacology outsourcing strategy and partnership with one major CRO.
• Redeployed studies without impacting any project timelines when one of the two internal, large GLP toxicology / safety pharmacology sites was closed
• Line manager accountable for the Resource Planning/Scheduling, Outsourcing, Documentation, Archiving, Communications, IS/IT units that supported the global toxicology function From March 2012 to August 2012 (6 months) Executive Director, Safety Assessment US @ • Represented Safety Assessment (toxicology and safety pharmacology) on Neuroscience and Infection Discovery project team review and governance bodies
• Led the harmonization of the Global Safety Assessment Discovery Toxicology strategy across all sites and regions.
• Contributed to the development, review and implementation of predictive toxicology and reactive metabolite screening strategies
• Department head of an experimental toxicology department that included anatomic pathology / clinical pathology, investigative molecular toxicology, safety pharmacology and in vivo toxicology capabilities
• Retained 90% of staff when leading relocation of staff and experimental capabilities from Wilmington, DE to Waltham, MA. From 2009 to 2012 (3 years) Director, Safety Assessment US @ • Directed department of 55 FTEs distributed across 3 research centers in North America that supported Neuroscience, Infection and Oncology therapeutic areas
• Fostered introduction of new technologies and Dx support screening strategies that reduced safety related attrition From 2000 to 2008 (8 years) Associate Director, Drug Disposition and Metabolism @ • Drug metabolism / pharmacokinetics representative on the global ARIMIDEX® development project team. PK/PD assessment of an efficacy biomarker was essential for appropriate dose selection and underpinned completion of the development program in less than 5 years. The program came from behind to achieve worldwide registration ahead of a competitor, and went on to become the #1 prescribed aromatase inhibitor for the treatment of breast cancer.
• Line manager of sections with accountability for in vitro and in vivo ADME, bioanalysis, pk, discovery support
• Initiated, assembled and led a cross-functional team of scientists from drug metabolism, pharmaceutical development, physical chemistry and toxicology supporting Discovery project teams From May 1988 to 2000 (12 years)
Postdoctoral Fellow, Pathology department @ CIITPhD, Biochemistry, Center in Environmental Toxicology @ Vanderbilt UniversityAB, Biochemistry @ Dartmouth College Martin Dyroff is skilled in: Toxicology, Drug Metabolism, Drug Discovery, GLP, Pharmaceuticals, Life Sciences, In Vivo, IND, Regulatory Submissions, Biochemistry, Pharmaceutical Industry, Lifesciences, Clinical Development, In Vitro, Pharmacology
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