Clinical Operations, Project Management,

HIMANSHU PARIKH

#****, ** *********** ****** ******, Mississauga, Ontario, L5R3Z5

Phone: 289-***-**** Mobile: 416-***-****

E-mail: ***********@*******.***

Objective

To have an intellectually stimulating and financially rewarding career in Medical and Scientific affairs function of the life sciences and healthcare industry, where my acquired skills and education will be utilized towards continued growth and advancement.

Career Summary

20 years of broad international pharmaceutical industry experience in medical affairs and clinical research. Responsible for several GCP compliant clinical trials, (Phase I/II) in North America (under US IND and CTA with TPD, HC), Europe, India and Australia. In-depth understanding of drug discovery and development processes in the field of Oncology, Diabetes and Inflammation with a special emphasis on translation research. Created a network of international KOLs to obtain inputs on various NCE programs. Excellent planning, organizational, analytical and management skills, with an ability to operate & manage in a matrix environment.

PROFESSIONAL EXPERIENCE

Piramal Healthcare Ltd. Aurora, Ontario July 2004 – To present

Vice President – Clinical Research (R&D)

Responsible for setting and heading the team of 27, in Clinical research department, including medical & scientific affairs, clinical operations, data management, safety surveillance and quality assurance functions. Implemented OC and OC-RDC data management tools. Played an active role in all early drug development efforts such as organizing toxicological evaluations, liaisioning with external toxicological consultants, CROs and planning and implementing translation and biomarker programs. Joint steering committee member of the scientific review team set up to oversee the co-development of compounds with Eli Lilly in diabetes and metabolic domain.

Oncology:

Ø Phase II clinical trial programs in indications such as Lymphoma (10 sites in US, 4 sites in Argentina), Malignant melanoma (6 sites in Australia), Head and Neck cancer (9 sites in India) and Multiple myeloma (5 sites in India).

Ø A combination Phase I program with chemo / radio therapy (Total of 14 sites) in India. 2 Phase I/II programs (Canada & India),

Ø 2 Phase I programs (India – 6 sites and Canada – 3 sites) evaluating different dosing schedules for an oral back-up molecule.

Ø Phase I/II program in refractory Chronic Myeloid Leukemia (CML).

Diabetes and Metabolic disorders

Ø Phase I program for an oral insulin sensitizer in Europe, initiated a Phase II program in type 2 diabetics in Europe/Central Eastern Europe/India.

Ø Phase I study with a specific Pharmacodynamic (PD) sub-study for metabolic syndrome NCE in Canada.

Ø Completed a single ascending dose (SAD) escalation program in Europe for a centrally acting appetite suppressant and have initiated a multiple ascending dose (MAD) escalation program with PD endpoints to guide future Phase II studies.

Ø Completed first of its kind, methods study incorporating a specific life style guidance program across 15 sites in India to generate valuable data in obese subjects.

Inflammation

Ø 2 Phase II programs in Rheumatoid Arthritis (DMARD naïve and DMARD non-responders).

Ø Phase II program in Psoriasis (In this study EDC tool was used)

Raptakos Brett & Co. Ltd. Mumbai, India Feb. 2003 – June 2004

Vice President – Medical

· Liased with the medical community and regulatory authorities.

· Provided medical inputs and justification for the proposed new products. Provided strategic inputs to the medico-marketing department of the company and helped in devising and approving promotional materials.

· Planned clinical trials on new and existing products. Updated technical dossiers on various products, answered queries from the field personnel and also from the medical fraternity.

Quintiles Spectral (India) Ltd. Mumbai, India Dec. 2001 – Dec. 2002

Director – Clinical Operations

· Responsible for Project Management and direction and line management of clinical staff, providing in-house and on-site mentoring in areas of site selection, budget negotiation, site initiation ensuring regulatory compliance, periodic site monitoring to ensure protocol and GCP adherence.

· Liaised with the sponsor companies. Medical Monitor on various clinical projects.

· Trained in Global safety surveillance and reporting procedures including Pharmacovigilance at Quintiles' Dublin, Ireland facility. Appointed Lead drug safety for the Indian operations.

· Played an active role in providing medical inputs for protocol review and generation of Data coding guidelines for Data Management unit of the organization.

Gufic Biosciences Limited Mumbai, India Oct. 1996 – Dec. 2001

Vice President – Medical & Scientific Affairs

· Provided medico marketing inputs for existing products and product development support for development of newer Phytopharmaceutical products.

· Initiated a new contract clinical research division ‘SPC Interface’. Developed and implemented standard operating procedures complying with ICH GCP guidelines. Undertook clinical trials on various products and organized Pre-clinical studies.

· Played active role at corporate level in formulating a strategic business plan.

Rallis India Limited (Tata Group) Mumbai, India Aug. 1994 – Oct. 1996

Medical Advisor

· Conceptualized medico-marketing strategies, gathered relevant references for various products. Initiated and conducted detailed training program for sales representative.

· Undertook seeding clinical trials and approved promotional material in coherence with the guidelines provided by IFPMA Code of pharmaceutical marketing practices.

· Compiled registration dossier for submission to Regulatory authorities and provided medical support for the registration of products in the export market.

Jwalin Pharmaceuticals Mumbai, India Sep. 1990 – Aug. 1994

Medical Advisor (Part Time)

Summary of qualifications

· M.B.B.S. (1989) Seth G.S. Medical College & K.E.M. Hospital, Mumbai University, India

· M.D. (1994) Grant Medical College & Sir J.J.Hospital, Mumbai University, India

Professional memberships / faculty

· Life member of Indian Pharmacology Society (IPS)

· Life member of Association of Physicians of India (API)

· Scientific advisory committee of The Indian Practitioner

· Life member of Research Society for Study of Diabetes in India (RSSDI)

· Alumni of Indian Institute of Management (IIM) – Ahmedabad, India

Publications and Presentation : Provided upon request.

Portfolio and References : Provided upon request.

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