Experience

Tarsus Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Vice President Clinical Development

  • Aug 2022 - Present



Sight Sciences

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• • Jun 2020 - Aug 2022

• • May 2018 - Jun 2020

  Direct and oversee short-term and long-term planning of regulatory submission initiatives.Review and change ongoing projects as needed.Negotiate with outside agencies as needed to resolve key regulatory issues.Expedite approvals of product and services and design and support clinical trial needed to support such approvalsPrepare responses to inquires from regulatory authorities.Prepare and submit applications and reports.Submit supplements and amendments to update registered product information.Prepare outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.Provide guidance to project teams and staff. Show less



Johnson & Johnson Vision

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Manager Clinical Research

  • Apr 2017 - May 2018

  Design and execute clinical trials in POC to post marketing phases for ophthalmic equipment for refractive and cataract surgery platforms. Responsible for writing clinical documents for submissions to regulatory committees. Develop recruitment strategies, provide clinical trial materials and guidelines, and manage the clinical trial. Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion. Have responsibility for the financial management of the clinical trial program including budget planning, resource allocation and preparation of reports. Coaching of CRAs in various aspects of management (eg HR, budgets, resource allocation) that are relevant to particular project issues. Implement training programmes for CRAs and other clinical staff with topics that include: principles and GCPs of project management, team communication, protocol and CRF writing, adverse event reporting and budget control and reporting. Provide scientific and clinical expertise to core teams and clinical teams. Develop clinical sections of product labeling. Provide insights in risk assessments and target product profile development. Show less



Allergan

• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Oct 2015 - Apr 2016

  Serve as a scientific expert in the ocular disease area. Ensure the medical/scientific validity and integrity of the clinical development program and study protocols. Support clinical study planning and execution through the development starting with the creation of the clinical development plan (CDP) and clinical study protocol synopsis, input into the clinical study protocol and clinical study report and clinical sections of the CTD for regulatory submissions. Work collaboratively with the cross-functional clinical Team to assess study data, integrate summaries of safety and efficacy, risk / benefit assessments, etc. Assist in building agency briefing packages, investigator brochures, clinical program feasibility, top line study data communication plan, and regulatory documents, including the clinical modules for submissions. Liaise with external experts/ key opinion leaders and provide regular scientific-medical disease state updates, etc. Represent the clinical team in the core project team. Ensure the development and execution of the clinical strategy. Show less

• • Jan 2013 - Oct 2015

  As a scientist and a project lead at Allergan, I developed ocular and visual disease models. Designed novel functional and structural endpoints to evaluate drug efficacy for neuroprotection, visual restoration, visual enhancement and disease reversal. Carried out experiments of high complexity independently, convert preliminary models into routine assays. Supervise and lead multidisciplinary project team. Act as KOL to provide clinical advise. Tested topical, oral, intravitreal, sub-tenons, peri-ocular and intracameral routes of drug delivery with endpoints such as psychophysics, electrophysiology (ERG, VEP), imaging with fluorescein angiography (FA), funds photography, ocular coherence tomography (OCT), autofluorescence, Heidelberg retinal tomography (HRT), slit lamp biomicroscopy, gonioscopy, laser photometry, specular microscopy, ultrasonography and blood flow, intraocular pressure (IOP), FLIO ophthalmoscopy, and histology. Show less



Actavis plc (now Allergan)

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pr Clinical Scientist

  • 2015 - 2016

  Ensure the medical/scientific validity and integrity of the clinical development/research program and study protocols. Support clinical development starting with the creation of the clinical development plan, study protocol, CSR and clinical sections of the CTD for regulatory submissions. - Collaborate to analyze and interpret clinical data. To integrate summaries of safety and efficacy, risk / benefit assessments, etc. To debrief topline data - Assist in building agency briefing packages, investigator brochures, procedure manuals, clinical program feasibility, top line study data communication plan, and regulatory documents, including the clinical modules for submissions. - As a member of ad-board liaise with external experts/ KOLs and provide regular scientific-medical disease state updates, etc. - Supervise and advise team to design and execute SQVs and eCRFs using EDC - Active involvement in budget planning Show less



University of California, Berkeley

• United States
• Higher Education
• 700 & Above Employee

• Research Assistant

  • Jan 2009 - Dec 2012

  -Conducting clinical research focused on identifying relationships and associations of structural and functional retinal damage in diabetes. -Using wide gamut of electrophysiological testing like mfERG, EOG and pattern ERG studying layer specific retinal damage in diabetes. -Performing retinal imaging using the adaptive optics scanning laser ophthalmoscope to study retinal blood flow in diabetes and analyzing the health of the photoreceptors. -Conducting clinical research focused on identifying relationships and associations of structural and functional retinal damage in diabetes. -Using wide gamut of electrophysiological testing like mfERG, EOG and pattern ERG studying layer specific retinal damage in diabetes. -Performing retinal imaging using the adaptive optics scanning laser ophthalmoscope to study retinal blood flow in diabetes and analyzing the health of the photoreceptors.



UC Berkeley

• UC Berkeley, School of optometry

• Graduate student instructor

  • Jan 2009 - Jan 2012

  I taught ocular anatomy and physiology to optometry students. I lead labs and proctor problem-based learning (PBL) sessions. I taught ocular anatomy and physiology to optometry students. I lead labs and proctor problem-based learning (PBL) sessions.



Tarachand Hospital

• Registrar Ophthalmology

  • Feb 2004 - Feb 2006

  -Conducting various ophthalmology speciality clinics -Conducting minor and major ocular surgeries mainly anterior segment like small incision cataract surgery, trabaculotomy and trabaculoplasty, dacrocystectomy and dacrocystorhinostomy etc. -Training intern doctors and make them ready for the ophthalmic exams and surgeries -Teaching fellow residents -Conducting various ophthalmology speciality clinics -Conducting minor and major ocular surgeries mainly anterior segment like small incision cataract surgery, trabaculotomy and trabaculoplasty, dacrocystectomy and dacrocystorhinostomy etc. -Training intern doctors and make them ready for the ophthalmic exams and surgeries -Teaching fellow residents



Pawar eye hospital

• Medical Officer and ophthalmic technician

  • Feb 2002 - Jan 2004

  -Assisting in various clinical procedures in a leading ophthalmology practice -Assisting in patient testing, refraction, general ocular check ups and various major and minor ocular surgeries -Helping in data collection for on-going research projects -Assisting in various clinical procedures in a leading ophthalmology practice -Assisting in patient testing, refraction, general ocular check ups and various major and minor ocular surgeries -Helping in data collection for on-going research projects



Gayatri Hospital

• Medical officer

  • Jan 2001 - Jan 2002

  -Conducting general medicine OPDs -Assisting in general and ObGyn procedures -Supervising intern and practicing doctors -Conducting general medicine OPDs -Assisting in general and ObGyn procedures -Supervising intern and practicing doctors