Carl Watkins Email and Phone Number

Early Phase Project Director working within the Global Strategic Solutions team for Janssen

Global Project Management of Phase II-IV clinical studies

Associate Director in late phase clinical development. I am assigned to deliver a programme of studies within the infection TA , to lead a cross functional team to deliver the clinical components of the NDA and EMA submission, scheduled to submit during Q1 2015. And lead the team through the regulatory defence preparation and Day 120 response builds through to late 2015.

Clinical Project Manager within the Infection TA: Leading the submission of a new antibiotic to the EMA and rest of world MarketsAs clinical submission lead for a cross functional global product team I project manage the delivery of a number of infection phase III studies through from lock, clinical interpretation, CSR production. leading crossfunctional teams in the delivery of the MAA submission summary documentation and Rest of World markets. Successfully managed the regulatory defence and gaining approvals within Europe, Australia, Mexico, Russia , South America and numerous key markets. This programme of work has also included delivering Asia clinical phase III studies, including their respective marketing submissions within China, Korea,Taiwan, India.

Working as a CRA and later as a study leader delivering studies from Phase I through to Phase IVPh I: Three Clin Pharm for oncology submissionPh I FTIM in haematology, Lung cancer Ph IIb prostate cancer study/ survival studyPh II Two Breast cancer ISS and AZ sponsored studies.Ph III Breast Cancer study and associated sNDA, MAA submissionsPh III global Infection studies and associated MAA and ROW submissionsPhase IV Casodex/Tamoxifen prostate cancerClinical Communication Leader Breast Cancer studiesLifecycle management Rheumatoid Arthritis

Biomarker and gene identification research

Cancer research ;Gene cloning of cancer related genes involved in testicular cancer.

Genome cloning techniques and marker identification used in human genome mapping