Chief Development Officer
Current
New Era Drug Development
Global Regulatory, Clinical Development and Operations Strategist and Advisor
Jan 2021 - Present
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Wesley Day Email & Phone Number
Global Regulatory and Clinical Development Consultant
at
New Era Drug Development
1 work email found
@mt-pharma-us.com
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
New Era Drug Development
Role
Global Regulatory and Clinical Development Consultant
Location
The Colony, Texas, United States
Who is Wesley Day? Overview
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Quick answer
Wesley Day is listed as Global Regulatory and Clinical Development Consultant at New Era Drug Development, based in The Colony, Texas, United States. AeroLeads shows a work email signal at mt-pharma-us.com and a matched LinkedIn profile for Wesley Day.
Wesley Day previously worked as Chief Development Officer at New Era Drug Development and Vice President and Head Clinical Development at Mitsubishi Tanabe Pharma Development America. Wesley Day holds Ph.D. (Emerson Fellow), Pharmacology And Toxicology from University Of Maryland, Baltimore (Umb).
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{first}_{last}@mt-pharma-us.com
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Profile bio
About Wesley Day
Over 30 years experience in global clinical development and regulatory strategy. All stages from discovery/IND, POC to NDA/MAA and commercialization. Rare disease development in autoimmune, CNS and dermal. • Led company efforts resulting in multiple successful NDA/EU submissions and subsequent approvals: Evamist 505(b)(2) -2007, Qsymia – FDC, 505(b)(2) -2012, and Stendra 505(b)(1) -2012 and sNDA (2014). Led Company efforts for EU MAA approval for Spedra (2013) and label expansion 2015. • Possess expert understanding for design and conduct of complex endpoint clinical trials. Have been responsible for successful trials in rare/orphan disease, dermal, immunology, women's health, CNS, metabolic diseases, CV, sexual health, TQT and various safety pharmacology designs. • Expert leadership of global Health Authority written and verbal communication, negotiations and strategy (FDA, EMA and EU member states). Presenter and moderator for FDA Advisory panels (2010, 2012), and also for the European CHMP Qsiva Oral Hearings (2012, 2013).• Possess expert safety risk management skills. Can effectively predict regulatory safety hurdles and design development program to mitigate risk. Have extensive experience negotiating how to address safety issues with FDA and EU health authorities.• Have built departments supporting preclinical, toxicology, and clinical research/development/operations, regulatory, and medical/safety functions, as well as other clinical functions, including clinical finance, medical writing, data management and biostatistics. • Oversaw the clinical efforts supporting medical affairs and the launch/commercialization of Qsymia.• Extensive global experience in setting of due diligence, alliance management, clinical studies, and health authority interaction for EU, Japan, China, South America, Australia and Hong Kong. • Over 100 publications/abstracts and, 6 issued and 19 patent applications
Listed skills include Clinical Development, Clinical Trials, Drug Development, Regulatory Affairs, and 46 others.
Current workplace
Wesley Day's current company
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New Era Drug Development
6 roles · 32 years
Wesley Day work experience
A career timeline built from the work history available for this profile.
Vice President And Head Clinical Development
Over a period of almost 4 years, delivered 6 INDs, rare disease/orphan drug designation and POC/EOP2 for global pipeline. Reporting to the President of MTDA, Dr. Day led the global clinical development for Mitsubishi Tanabe. The creation of this role aligned with Mitsubishi Tanabe’s medium term strategy of shifting key global drug development leadership roles from Japan to the US in the areas of project management, stage gate governance, and certain development functions including clinical science, operations, finance, regulatory and vendor management in order to optimize the development and commercialization of the company’s expanding portfolio.KEY RESPONSIBILITIESManaged Clinical Science, Clinical Operations, Data Science, Medical Writing Clinical Finance and Project Management functions.Working closely with the US President and other colleagues in the US, the EU and in Japan, served as a key contributor to the implementing organizational vision for Global Development.Directed and managed Early Development Team Leaders (EDTLs) and clinical operation team leaders (COTLs) supporting clinical development, clinical operations, drug safety and regulatory affairs.Directed the execution of clinical development from preclinical through late stage development globally. Key deliverables included development of clinical development plans, creation of clinical protocols, overseeing clinical operations, data science, finance and budgets, project management and medical writing.Develop the organizational capability to support global clinical development.Chaired the Protocol Review Committee (PRC).
Aug 2016 - Mar 2020
Chief Development Officer
New Era Drug Development Inc
Providing Consulting Services in the following: Regulatory :• Specializing in creation of 505(b)(2) and fixed-dose combination (FDC) strategy for purposes of designing stream-lined drug development programs and supporting pre-IND meeting planning. • NDA /MAA planning and writing, • US and EU advisory committee meeting preparation and conduct, • Complex global health authority communication and negotiations.Clinical: • Specializing in early to late stage clinical trial design, strategy, operations, large trial design and global trial management. Regulatory Safety and Pharmacovigilance: • Safety strategy and assessment in global development programs• Development of risk management plans, complex safety issue management, pharmacovigilance, and health authority communication and negotiation. Clinical/Regulatory Documentation - • Specializing in complex medical writing and messaging, including pivotal regulatory submissions such as IND, IB, briefing documents, eCTD development and writing - modules 1, 2, 4 and 5.
Jan 2016 - Aug 2016
Vice President Clinical Development
Most senior Executive team member responsible for global non-clinical and clinical research/development/operations/submissions and associated functions, including regulatory strategy. Served as the most senior scientific/clinical leader for the company regarding external presentations, health authority interactions or analyst meetings. Responsible for global clinical research and development organization and all clinical trials from pre-clinical to Phase III/IV and commercialized products including oversight and management of clinical data management functions. Oversaw the clinical research activities including design and conduct of clinical trial protocols, data management strategies and systems, development of required reports and regulatory filings to gain product approval. Developed operational plans for managing clinical research activities, including activities to be performed in-house or through third-party relationships, and clinical trials according to the strategic plan to support product approval in US and EU. Interacted with various groups within the company, and external to the business, in the execution of clinical research/development activities. Managed strategic level decisions regarding regulatory strategy and negotiations worldwide regarding all aspects of clinical development and approval submission processes. Served as primary moderator and presenter for Qsymia FDA Advisory Panels (July 2010 and Feb 2012) and was recognized as the “architect” behind the novel complex clinical program supporting this product’s approval. Qsymia and Stendra named by Forbes as 2 of top 7 new drugs of 2012. Extensive product launch support with commercial/marketing and medical affairs involving market access, payers, training, interaction with, KOLs, analysts/investors. Major accomplishments include:• NDA Evamist –Approved 7/2007• NDA Stendra –Approved 4/2012• NDA Qsymia – Approved 7/2012 • MAA Stendra – Approved 6/2013• sNDA Stendra – Approved 9/2014
Oct 2005 - Dec 2015
Adjunct Associate Professor
Graduate student advisor and course instructor for PhD and PharmD level courses including drug development, toxicology, and pharmacology and therapeutics for metabolic disease, cardiovascular, ophthalmology and oncology.
1995 - 2014
~19 yrs
Various Roles
Dr. Day held a variety of positions with Pfizer, Inc. from 1993 until his departure in October 2005. Most recently, Dr. Day was the Senior Director/Therapeutic Area Head - Oncology and Ophthalmology in Risk Evaluation and Documentation/Worldwide Regulatory Affairs - from September 2003 until his departure. Prior to this position, Dr. Day served as the La Jolla Site Head and Senior Associate Director, for Safety Risk Management in Worldwide Regulatory Affairs from August 2001 to 2003, Associate Director II, Global Safety Leader in Worldwide Regulatory Affairs from 2000 to 2001. Prior to joining Worldwide Regulatory Affairs, Dr. Day was a clinician in Clinical Development - Associate Director I - responsible for phase 2 and phase 3 clinical programs from 1999 to 2000 and, Senior Clinical Research Investigator leading metabolic disease and women's health clinical programs from 1997 to 1998. Dr. Day started his career in Drug Discovery running a pharmacokinetics/ADME lab - Senior Research Scientist from 1995 to 1997 and Research Scientist from 1993 to 1994.
Feb 1993 - Oct 2005
4 education records
Wesley Day education
Ph.D. (Emerson Fellow), Pharmacology And Toxicology
University Of Maryland, Baltimore (Umb)
Bachelor Of Science (Bsc) Highest Honors, Biology
The University Of Texas-Pan American
Education record
Oral Roberts University
Ort, Surgical Technology
Texas State Technical College
FAQ
Frequently asked questions about Wesley Day
Quick answers generated from the profile data available on this page.
What company does Wesley Day work for?
Wesley Day works for New Era Drug Development.
What is Wesley Day's role at New Era Drug Development?
Wesley Day is listed as Global Regulatory and Clinical Development Consultant at New Era Drug Development.
What is Wesley Day's email address?
AeroLeads has found 1 work email signal at @mt-pharma-us.com for Wesley Day at New Era Drug Development.
Where is Wesley Day based?
Wesley Day is based in The Colony, Texas, United States while working with New Era Drug Development.
What companies has Wesley Day worked for?
Wesley Day has worked for New Era Drug Development, Mitsubishi Tanabe Pharma Development America, New Era Drug Development Inc, Vivus Inc., and University Of Maryland Baltimore.
How can I contact Wesley Day?
You can use AeroLeads to view verified contact signals for Wesley Day at New Era Drug Development, including work email, phone, and LinkedIn data when available.
What schools did Wesley Day attend?
Wesley Day holds Ph.D. (Emerson Fellow), Pharmacology And Toxicology from University Of Maryland, Baltimore (Umb).
What skills is Wesley Day known for?
Wesley Day is listed with skills including Clinical Development, Clinical Trials, Drug Development, Regulatory Affairs, Pharmaceutical Industry, Pharmacology, Clinical Research, and Fda.
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