Tom Goodin Email & Phone Number

Boston, MA, US

Marlborough, MA, US

• Individual contributor role evolved into a co-lead of the SUN-101 NDA submission for a nebulized bronchodilator to treat COPD. SUN-101 is a glycopyrrolate solution inhaled into the lungs using an innovative electronic.
• Co-developed presentation strategy for pre-NDA briefing book
• Responsible for strategy and authorship of clinical study reports (CSRs), ISE, ISS and Clinical Overview.
• Co-authored the CMC Device Performance Overview to support CDER and CDRH reviews. Global Program Leader-Respiratory August 2016. Led cross-functional development team and provided a shift to a vision, mission and.
• Responsible for FDA information requests during NDA review and approval.
• Internal and external product champion for 5 respiratory portfolio products (handheld DPI and nebulized); including communication of clinical information to internal and external stakeholders.

Cambridge, MA, US

Led a team of high-performing Directors who integrated scientific and broad operational expertise to develop effective and innovative Clinical Development Plans (CDP) in close collaboration with Medical Research and other functional subject matter experts across the entire development portfolio including CNS and rare diseases (~ 120 studies). The Directors.

US

Responsible for integrating MCDA (multiple criteria decision analysis) modeling into R&D portfolio, project and in-licensing strategies and investments as an Experimental Medicine and Science department corporate initiative.Expand and develop departmental translational medicine capabilities.Interim Respiratory Therapeutic Area Head (September 2012-June.

US

Served as clinical sub-team leader and PDTL included responsibility and accountability for leadership in a matrix team responsible for the development and implementation of commercial, scientific and regulatory strategies for the clinical development/registration of aclidinium bromide for all indications throughout the product life-cycle with an ex-US.

Honolulu, HI - Hawaii, US

Key management hire to provide leadership in the development and implementation of corporate business/finance, scientific, clinical and regulatory strategies. Cardax is a small biotech company developing a platform of novel natural product derivatives (i.e. carotenoids) for the treatment of acute and chronic disease states characterized by oxidative.

Paris, France, FR

Responsible for operational oversight and primarily post-marketing support of US Cardiovascular-Thrombosis Therapeutic team including the Plavix®, Lovenox®, Avapro®, Avalide® and Multaq® brands that collectively accounted for approximately $6B in US sales. The primary responsibilities of this position included: local and global brand planning, clinical.

Paris, France, FR

Responsible for operational oversight and primarily post-marketing support of Uroxatral®, Ambien® and Eloxatin® clinical programs. The primary responsibilities of this position were clinical trial oversight/design, personnel management, and departmental/corporate administrative responsibilities including budget planning/management. Developed preliminary.

US

The primary responsibilities of this position include strategic development of clinical programs, clinical trial oversight/design, personnel management, and departmental/corporate administrative responsibilities.Developed strategy to stimulate enrollment in a multicenter (40 sites) Phase II prostate cancer trial. Shared corporate award with Oncology team.

US

The primary responsibilities of this position included strategic development of clinical programs, clinical trial oversight/design (Phase I-IV), scientific consultant to the corporate business development group, personnel management, and departmental/corporate administrative responsibilities.Worldwide clinical program leader for the Phase I-III development.

Recruited as an original employee of the company and was responsible for setting-up, equipping and staffing the corporate laboratories.Designed and managed developmental, GLP pre-clinical safety/pharmacology and efficacy evaluations of a synthetic oxygen carrier, Oxyfluor, from product conception through IND approval (IND #5015: Perfluorochemical Emulsions.

Irvine, CA, US

Research efforts focused on the use of a rodent exercise model for evaluating oxygen transport physiology in animals hemodiluted with crystalloid solutions or a stroma-free hemoglobin solution. Preliminary results from these developmental studies suggested that the physiological parameters of exercise may be a useful means to quantitate the oxygen.

Cambridge, Massachusetts, US

The research collaboration with Dr. Robert Geyer resulted in the development of a number of fundamental biological, toxicological and physiological methods for perfluorocarbon emulsion evaluation. These methods were utilized in both rodents and primates to evaluate the safety and efficacy of: 1) Fluosol-DA which was being commercialized by Alpha.

Doctor Of Philosophy (Ph.D.), Physiology

Bgs, Biological Sciences