Director, Regulatory Support @ Diabetes Research Institute
Lead Clinical Research Pharmacist/Clinical Pharmacologist- Clinical Trials Phase I to IV @ University of Miami Hospitals and clinics
Staff Pharmacist @ Walgreens
Master Diploma in Business Administration @
Indian Institute of Modern Management (BIMM), Pune
A motivated professional and a team player with 11 years of experience in leading and managing clinical drug development programs. Demonstrated ability to critically review, evaluate and interpret scientific data. Expertise in clinical research program start-up and ongoing development/growth. Serve as a cross-functional leader and a strong team player to effectively interface with other internal
A motivated professional and a team player with 11 years of experience in leading and managing clinical drug development programs. Demonstrated ability to critically review, evaluate and interpret scientific data. Expertise in clinical research program start-up and ongoing development/growth. Serve as a cross-functional leader and a strong team player to effectively interface with other internal departments, including clinical informatics, research and business analysis, budget and contract negotiations, quality assurance and regulatory department, and audit/monitoring division.
Specialties: Clinical Trial Feasibility and Operations, Project Management of Diverse Therapeutic Area, Strong Negotiation Skills, Strategic Planning/Development, Creative/Innovative Thinking, Leading/Developing Teams, Building Programs, Achieving results.
Skill Highlights: Drug Development, Phase I to IV Trials, ICH/GCP Guidelines and FDA Regulations, Regulatory Dossier, Multiple Therapeutic Areas, Design of Research Protocol, Research Compliance, Data Safety Monitoring, Team Player and Problem Solving Skills, Communication Skills, Human Subject Protection, Pharmacovigilance and Drug Safety.
Director, Regulatory Support @ From December 2014 to Present (1 year 1 month) Lead Clinical Research Pharmacist/Clinical Pharmacologist- Clinical Trials Phase I to IV @ - Maintain complete oversight of the day-to-day operations of the IDS in following areas: regulatory affairs, quality assurance, budgeting/financial systems, informatics, and new policy & procedure development.
- Monitor compliance with federal, state, local and institutional laws, regulations, and guidelines.
- Design and develop investigational protocols, disseminate pharmacological drug information from research protocols, peer reviewed reports, and scientific journals to advise principal investigators, physician-scientists and research staff for better treatment outcomes.
- Conduct clinical research by randomizing, blinding, recommending dose-delay/dose modifications, drug discontinuation and drug interactions.
- Education and patient counseling to enrolled clinical research subjects regarding the pharmacotherapeutic plan, concurrent drug therapies, and outcomes.
- Cross functional collaboration with regulatory, ethics, medical affair, confidentiality, informed consent, and ensure Good Clinical practices for development of novel therapeutics.
- Serve on Data Safety Monitoring Committee, Protocol Review Committee, Institutional Review Boards and Clinical Research Feasibility Committee. From December 2008 to November 2014 (6 years) Staff Pharmacist @ - Manage and execute drug utilization review, prescription Data review, counseling, product verification, serve patients with geriatric/psychiatric populations, Implement Medication Therapy
- Counseling on prescriptions and OTC /nutritional/herbal supplements, effective work-flow balance supervising certified pharmacy technicians. From October 2006 to December 2008 (2 years 3 months) Miami/Fort Lauderdale AreaPostdoctoral Research Associate, Pharmacology @ - Established working knowledge of literature and methodology pertinent to current research activities, pharmacological techniques and recommends improvements/innovations in response to identified needs.
- Developed behavioral models significant to project goals of pharmacological screening.
- Design and execute the experimental protocols, behavioral interpretation of the data using advanced analytical software.
- Presentation of the progress report of the projects and drafting results for publications. From December 2004 to September 2006 (1 year 10 months) Tampa/St. Petersburg, Florida AreaSenior Research Fellow, Council of Scientific and Industrial Research @ - Built and managed 5-member support team toward research and analysis, process improvement recommendations, project management resources, and on-site lab coaching for master of pharmacy students.
- Facilitated monthly brainstorming meetings developing solutions that improved research productivity and publication speed of the laboratory.
- Recipient of awards and fellowships from Pharmaceutical Industries and Federal departments for excellence in research and academia in the field of Pharmacology.
- Conducted thorough evaluation of research protocols and provided recommendations on adapting amendments to meet individual project needs.
- Served as contributory lecturer to teach pharmacology courses to masters/graduate pharmacy students From June 2002 to December 2004 (2 years 7 months) Research Intern - Neuronal Circuit Mechanisms Research Group @ -Advanced training on research design, data analysis, methodology research with intensive course featuring distinguished international faculty. From June 2003 to September 2003 (4 months) Junior Research Fellow, Neuroscience @ Neuroscience curriculum, Journal clubs, behavioral protocols, molecular and cellular pharmacology . From August 2001 to July 2002 (1 year) Gurgaon, IndiaJunior Research Fellow (University Grant Commission), Pharmacology @ Design and development of research protocols, grant writing, present scientific data for annual reports and journal publications, represent in professional conferences and societies. From August 1999 to July 2001 (2 years) Nagpur Area, IndiaGraduate Pharmacy Intern @ - Pharmaceutical Industrial Training Program with rotation in quality control, quality assurance, regulatory, Instrumental and packaging and manufacturing divisions that forms basis of clinical drug development operations in the fast growing & progressive ISO 9001-2000 certified company. From April 1998 to March 1999 (1 year) Mumbai Area, India
PhD in Pharmacology under Faculty of Medicine, Pharmacology @ Nagpur University Department of Pharmaceutical Sciences From 2001 to 2004 Master Diploma in Business Administration @ Indian Institute of Modern Management (BIMM), Pune From 2002 to 2003 Master of Pharmacy, Pharmacology, University First Rank @ Nagpur University Department of Pharmaceutical Sciences From 1999 to 2001 Bachelor of Pharmacy (BPharm), Pharmacy, Valedictorian - Best Outgoing Graduate @ Manipal College of Pharmaceutical Sciences (MCPOS), Mangalore University From 1994 to 1998 Diploma in Pharmacy, Pharmaceutical Sciences, Valedictorian - Best outgoing student @ Manipal College of Pharmaceutical Sciences - Karnataka State Board Examination From 1992 to 1993 Khemraj Hirani is skilled in: Clinical Trials, Pharmacology, Lifesciences, Clinical Research, Oncology, Biotechnology, Regulatory Affairs, Clinical Development, Molecular Biology, Drug Discovery, Pharmacokinetics, Cancer, In Vivo, Drug Development, Neuroscience
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