Michael Willett, PharmD

Experience

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  Wesley Long Community Hospital

  Jan 1987 - Jan 1988

  Clinical Pharmacist

  Responsible for providing pharmacotherapy consultative services to pharmacy, nursing and medical staff with an emphasis on critical care, cardiology, infectious diseases and pain management. Provided therapeutic drug monitoring (TDM) services for antibiotics, anticonvulsants, antiarrhythmic, anticoagulant and thrombolytic drugs. Promoted cost-effective use of antibiotics and other drugs. Involved in Pharmacy & Therapeutics Committee. Assisted in establishing nutritional support team and implementation of updated ACLS guidelines. Show less

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  Marion Laboratories

  Jan 1988 - Jan 1990

  Clinical Research Associate - Cardiovascular Section

  Responsible for Phase I-III clinical study monitoring and project management in support of cardiovascular drug development. Involved in clinical study protocol design, study data analysis and preparation of NDA clinical data technical sections, clinical study reports and regulatory agency advisory panel meetings.

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  Bristol-Myers Squibb

  Jan 1990 - Jan 1992

  Responsible for designing and managing Phase IIIb-IV clinical trials in support of cardio-renal drugs. Involved in providing medical operations support to sales and marketing staff. Liaised with key cardiovascular opinion leaders. Responsible for designing and managing Phase IIIb-IV clinical trials in support of cardio-renal drugs. Involved in providing medical operations support to sales and marketing staff. Liaised with key cardiovascular opinion leaders.

  • Assistant Director, Clinical Trials - Cardio-Renal Section

    Jan 1991 - Jan 1992

  • Medical Manager, Cardio-Renal Section

    Jan 1990 - Jan 1991
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  Health & Sciences Research, Inc. (HSRI)

  Jan 1992 - Jan 1994

  A full service clinical CRO providing Phase I-IV clinical testing services for new product development for pharmaceutical, biotechnology and medical device companies. Provided senior scientific, regulatory and strategic consultation and new product assessments for development stage companies. Provided senior scientific, regulatory and strategic consultation and new product assessments for development stage companies.

  • Director, Operations

    Jan 1993 - Jan 1994

  • Director, New Product Development

    Jan 1992 - Jan 1993

  • Associate Director, New Product Development

    Jan 1992 - Jan 1992
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  Advanced Biomedical Research, Inc.

  May 1994 - May 2009

  President, CEO & Founder

  ABR is a privately held full-service CRO managing Phase I-IV clinical trials in North America, Europe and Asia. Our CRO operations have managed and monitored multinational Phase II-III clinical trials in such indications as CNS, CV, metabolic and oncology disorders. We have a state-of-the-art 72-bed Phase I-II clinical pharmacology unit (FIHT, BE, BA, SAD, MAD, QTc) and a Phase II-III outpatient clinic in special populations, including early CV and metabolic disorders (endothelial dysfunction, hypertension, obesity, dyslipidemias, pre-diabetes, T2DM), postmenopausal women, osteoporosis, respiratory medicine, secondary hypogonadism and reproductive medicine. Show less

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  Frontage Clinical Services

  Jun 2008 - Sept 2009

  Dr. Willett serves as a senior scientific advisor in support of the Frontage Clinical Services (ABR) Phase I-IIa clinical pharmacology unit and it's early phase clinical activities. Frontage Clinical Services is the clinical division of Frontage Laboratories, with offices in North America (New Jersey and Pennsylvania) and Beijing and Shanghai, China. Frontage Laboratories is the parent company of Advanced Biomedical Research, Inc. (ABR).

  • Senior Scientific Advisor

    May 2009 - Sept 2009

  • President

    Jun 2008 - May 2009
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  Ready Clinical LLC

  Apr 2009 - now

  President & CEO

  ReadyClinical is a clinical and regulatory consulting and training services company to the pharmaceutical, biotechology and medical device industry. ReadyClinical provides senior project management, study monitoring, quality assurance auditing, data management, statistical analysis, medical writing and regulatory submission services. ReadyClinical offers GCP training and SOP development to early stage biopharma companies and investigators. Dr. Willett, Ready Clinical's Founder and President, provides senior clinical, scientific, regulatory, pharmacokinetic and medical writing consultative services to pharmaceutical and biotechnology companies and CROs in support of early phase clinical development. Show less

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  HCR America

  May 2009 - Feb 2010

  President & Managing Director

  HCRAmerica is the US affiliate of Harrison Clinical Research, GmbH a full-service international clinical CRO with a staff of 450 clinical research professionals and offices in 12 countries throughout the USA, Europe and Russia. HCR also has well established affiliated CRO partners in Canada, Scandinavia, South America, South Africa, Australia, India and Japan. Your full-TRUST CRO, Harrison Clinical Research has a 22-year track record of service excellence in providing Timely and Reliable performance of clinical trials. Harrison Clinical Research has the Understanding and Strategic network to offer a full range of clinical research activities throughout the USA, Europe and worldwide. Our Team is proud of its quality and is ISO 9001 certified for the performance of Phase I, II and III clinical trials. Show less

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  HCRAmerica, LLC

  Mar 2010 - Mar 2013

  Sr Director, Regulatory & Scientific Affairs

  Provide senior regulatory & scientific consulting support for USA and international clinical trials, clinical and regulatory strategic planning and regulatory submissions.

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  Frontage Laboratories, Inc

  May 2016 - now

  Executive Director, Strategy and Regulatory Affairs

  Dr. Willett provides senior regulatory, clinical, pharmacokinetic and medical writing services to the Frontage Clinical Services team.

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  AXIS Clinicals USA

  Mar 2019 - Feb 2020

  Senior Advisor, Clinical & Scientific Affairs

  Dr. Willett provided senior scientific input into the design and execution of early phase clinical trials in support of innovative drugs and biologics and enhanced 505(b)2 products.