Paresh Soni

Chief Development Officer (CDO) @Causeway Therapeutics

New London County, CT, US
EMAILS
p••••••••@causewaytx.com
MOBILE NUMBERS
+18•••••••27

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WORK HISTORY

Sep 2024 — Present

Chief Development Officer (CDO) @Causeway Therapeutics

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New London County, CT, US

Oversees strategy driving the clinical development of TenoMIR.

EDUCATION

N/A

University of KwaZulu-Natal

MBChB, Medicine

SKILLS

PharmaceuticsClinical TrialsCross-Functional Team LeadershipPharmaceuticalsLife SciencesClinical ResearchDue DiligenceMedical AffairsTeam BuildingStrategic PlanningStrategyBiotechnologyPortfolio ManagementR&DOncologyRegulatory AffairsLifesciencesCROInfectious DiseasesPharmaceutical IndustryDrug DevelopmentClinical Development

ABOUT PARESH SONI

Experience in large and small pharma with broad medical/scientific and corporate management background who has led teams across the entire development spectrum – from translational medicine to successful approval. Board-certified internist and gastroenterologist with experience leading global multidisciplinary project teams, and developing drugs for liver diseases. Proven record of submission of multiple NDAs leading to marketed products. Multinational experience across many Therapeutic Areas including GI/Hepatology, Rare diseases, CV/Metabolic, ID, Hematology, Urology/Sex Health. Led review of external pipelines and drug candidates for potential partnering, as well as creation and implementation of TA strategies, member of governance bodies. Line management of clinical and non-clinical personnel. Highly strategic leader who has led regulatory negotiations with US FDA, EU and international medicines agencies for all development milestones from IND to label and NCE approvals. Recapitalized publicly-traded small pharma company to commencement & completion of Phase 3 program, NDA submission and approval of lipid-lowering therapy (Vascepa®). Strategically directed the growth of the company from a small clinical-stage drug developer into a commercial enterprise of more than 400 employees. Member of executive management team at investor & earnings calls; participated in several capital raises. Extensively published; presented numerous papers at academic meetings and conferences; multiple awards and peer reviews.

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