Prashant Chikramane, Phd Email & Phone Number

Mumbai, India (Currently Based In Usa)

Key Deliverables● Reporting to Vice President (VP), Clinical Operations (CO)● Handling/handled DCT Phase II-IV programs including Oncology, Gastroenterology, Respiratory, Endocrinology and Neurology.● Leading Clinical Project Management (CPM) and CO teams – Team strength: ~75-80, including 12 Project Managers (PMs), 08 Clinical Team Leads (CTLs), CRAs and other functionalities, in a cross-functional matrix-driven environment.● Identify/develop relations with SMEs/KOLs, for… Show more Key Deliverables● Reporting to Vice President (VP), Clinical Operations (CO)● Handling/handled DCT Phase II-IV programs including Oncology, Gastroenterology, Respiratory, Endocrinology and Neurology.● Leading Clinical Project Management (CPM) and CO teams – Team strength: ~75-80, including 12 Project Managers (PMs), 08 Clinical Team Leads (CTLs), CRAs and other functionalities, in a cross-functional matrix-driven environment.● Identify/develop relations with SMEs/KOLs, for inputs for protocol design.● Responsible for quality conduct of studies, review of TLFs, and review/interpretation of clinical/safety data● Participate/lead governance steering meetings with Sponsors.● Successfully completed/currently handling programs (Total cost: ~USD 20.0M). Leading bids from various Indian and Multinational Pharma clients. Responsible for Client relationships to create new business opportunities.● Help achieve organizational growth and initiatives. Oversee planning, tracking and implementation of projects within defined timelines, quality, processes and policies and budgets.● Strategic role – o Oversee, plan and implement appropriate actions to develop scientific and technical expertise. o Provide inspirational leadership.o Establish and maintain costs/utilization metrics of all functions to drive organizational profitability.● Ensure departmental productivity and efficiency through,o Project planning, scheduling and executiono Financial management, analysis of project risks, talent and resource management.● Author departmental Standard Operating Procedures (SOPs)● Provide leadership during crisis management to ensure business continuity for the organization.● EDC and CTMS systems – LifeSphere Show less

Ahmedabad, Gujarat, India

Key Deliverables● Reported to VP, Clinical Operations● Handled DCT programs in Oncology, Neurology, Neuropsychiatry, Dermatology and Ophthalmology.● Led CPM/CO team of ~40 members, including 05 PMs, 08 CTLs, CRAs and other functionalities.● In conjunction with Medical, Sponsor and external SME/KOLs, involved in study design and protocol development, interpretation of study data (efficacy/safety) for making go/no-go recommendations pertaining to product… Show more Key Deliverables● Reported to VP, Clinical Operations● Handled DCT programs in Oncology, Neurology, Neuropsychiatry, Dermatology and Ophthalmology.● Led CPM/CO team of ~40 members, including 05 PMs, 08 CTLs, CRAs and other functionalities.● In conjunction with Medical, Sponsor and external SME/KOLs, involved in study design and protocol development, interpretation of study data (efficacy/safety) for making go/no-go recommendations pertaining to product development.● Successfully handled programs (Total cost: ~USD 10.0M). Led bids and won contracts from global Pharma clients. ● Led and drove clinical development programs, by ensuring that the strategic direction and internal capabilities of the clinical trials business unit are consistent with quality standards and client expectations.● Led clinical programs as Project Director, from concept to Clinical Study Report (CSRs), in compliance with program budgets, timelines, and the applicable SOPs, ICH-GCP guidelines and regulatory standards (USFDA/EMA).● Chaired/participated in team meetings to develop/implement new departmental/organizational goals, policies and strategies and ensured team is kept abreast of these changes. ● Responsible for providing training, guidance and mentorship to team members, as deemed necessary.● Responsible for client issue escalation and resolution. ● Responsible for program-level reporting of progress, risks, and issues to upper management.● Along with SMEs/KOLs, initiated external training programs in the organization. Show less

South Plainfield, Nj

Key Deliverables● Dual Reporting to CMO and VP, Clinical Development● Led clinical programs of novel biologics for various indications, including rare diseases – Sickle cell disease, Chronic Neutropenia, Acute Ischemic Stroke (total cost of programs: ~USD 10.0M)● Led team (~7-10 members); managed multiple CROs/third-party vendors in the USA/EU● Responsible for review/interpretation of clinical/safety data to provide go/no-go recommendations from safety/efficacy standpoint to key… Show more Key Deliverables● Dual Reporting to CMO and VP, Clinical Development● Led clinical programs of novel biologics for various indications, including rare diseases – Sickle cell disease, Chronic Neutropenia, Acute Ischemic Stroke (total cost of programs: ~USD 10.0M)● Led team (~7-10 members); managed multiple CROs/third-party vendors in the USA/EU● Responsible for review/interpretation of clinical/safety data to provide go/no-go recommendations from safety/efficacy standpoint to key stakeholders/investors● Contributed/participated in discussions on potential biomarker identification, FIM design, early phase proof-of-concept studies based on drug PK/PD ● Identified/developed SMEs/KOLs relations, Advisors/Consultants for discussions on drug development strategies● Contributed to TPP preparation, identification of potential indications● Reviewed/approved clinical sections of regulatory-submission documents: CSRs, INDs, IND amendments, BLA, DSURs, IB, Briefing Book, IMPDs● Contributed to protocol synopses, final study protocol development● Responsible for final approval of clinical documents –Master ICF, PMP, Communication Plan, Pharmacy manual, MMP, SAP, RMP, DMP, eCRF design, DMC charters● POC for regulatory agencies including USFDA, EMA, ANSM, AIFA (Italy) and ECs to address their queries/concerns on clinical submissions● Contributed/participated in medical monitoring activities, identification of study outliers, trends, and safety signals to determine the product’s overall safety/efficacy profiles● Involved in preparation and review of abstracts/manuscripts for peer-reviewed scientific journals, posters/presentations for scientific meetings/congresses● Responsible for periodic review and updates of SOPs● Participated in training CRO teams/site staff, during IMs, SIVs● Provided support during audits/Regulatory inspections; assisted in CAPA implementation● Handled eTMF (Veeva Vault, SharePoint), EDC systems (Medidata RAVE, Medrio, Oracle RDC, InForm) Show less

South Plainfield, Nj

Miami/Fort Lauderdale Area

Key Deliverables● Successfully completed Phase II/III studies of a novel biologic and global Phase Ib/IIa study of New Chemical Entity (NCE) for End-Stage Renal Disease (ESRD)● Managed a team of 06 CRAs and over 80 sites across the USA● Point-of-contact with Sponsor team in discussion of recruitment strategies to ensure timely study completion● Successfully completed 03 USFDA inspections and 07 Sponsor/in-house audits. Responsible for CAPA implementation● Contributed towards… Show more Key Deliverables● Successfully completed Phase II/III studies of a novel biologic and global Phase Ib/IIa study of New Chemical Entity (NCE) for End-Stage Renal Disease (ESRD)● Managed a team of 06 CRAs and over 80 sites across the USA● Point-of-contact with Sponsor team in discussion of recruitment strategies to ensure timely study completion● Successfully completed 03 USFDA inspections and 07 Sponsor/in-house audits. Responsible for CAPA implementation● Contributed towards implementation of in-house Clinical Trial Management System (CTMS)● Involved in end-to-end management of all operational aspects (start-up to close-out) of clinical studies, including vendor selection and oversight, finalization of study protocol and other study-related documents, regulatory/EC submissions, TMF and clinical database including UAT● Involved in preparation and validation of study documents including protocol, ICF, patient material● Extensively involved in training internal clinical team and site personnel during IMs, SIVs and other forums● Handled eTMF (SharePoint), EDC systems (Medidata RAVE, DataLabs) Show less

Miami/Fort Lauderdale Area, Fl, Usa

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Doctor Of Philosophy (Phd), Nanotechnology, Nanomedicine, Cpi - 8.88/10

Master Of Pharmaceutical Sciences (M.Pharm.Sci.), Medicinal Chemistry, First Class With Distinction

Bachelor Of Pharmacy (B. Pharm), Pharmaceutical Sciences, First Class