Jeroze Dalal

• Planned & executed 50+ Evidence Generation (EG) and Life Cycle Management (LCM) Projects to maximize growth and business opportunities for established products.
• Effectively managed budget and resource strategy.
• Implemented Code of Practice, Scientific Engagement (SE) and other medical governance/policy requirements.
• Reviewed all medical activities and identifying risks and process improvements. Facilitating resolution of any governance or operational issues. Reviewing on-going and emerging risks and ensuring CAPAs are identified to resolve them.
• Lead Management Monitoring (MM), Independent Business Monitoring (IBM) and Internal audits.
• Developed and implemented performance improvement strategies and plans to promote continuous improvement.

• Lead planning & management of assigned clinical programs from an end-to-end trial management perspective to achieve objectives of Global Programs.
• Complete oversight of budget and resource allocation within assigned clinical programs.
• Drove operational excellence through process improvement and knowledge sharing across clinical programs.
• Key contributor to operational strategy; provide global clinical operational input into Integrated Development Plans (IDP) for assigned programs including “ Malaria Early Development ” Program;
• Built Centre of Excellence in clinical trial execution. Provided oversight on quality and compliance.
• Built best talent and an empowered culture within programs to foster high performance in a matrix environment. Enabled an empowered organization which can navigate in a matrix environment and adjust quickly to business needs.
• Lead Leprosy Flagship Program ; by executing “LEAD” study which essentially was for leprosy patch detection using clinical datasets with Siamese Network Architecture. This Artificial Intelligence based tool could be effective for early screening of leprosy; allowing patients to get early treatment; thereby reducing the financial and personnel burden for leprosy screening. Data on file, yet to be published.
• Local Site Head responsibilities: Member of Novartis Hyderabad Global Drug Development (GDD) Leadership leading team of 87 associates in Hyderabad in addition to 6 global associates.
• Line management of Global Trial Directors (GTDs), Process Control Manager (PCM), Risk Management Director & Innovation Manager in Hyderabad
• Managed team of employees, overseeing hiring, training and professional growth of employees.

• Lead a team of Global Trial Leaders & Clinical Managers in the strategic planning and operational execution of high-quality clinical programs/trials according to GCP, ICH and FDA guidelines and within agreed trial timelines and budget.
• I was the only GCOL at Hyderabad, with combined program & local site management responsibilities for 85 staff.
• Provided guidance, mentoring, and assistance in setting workload priorities, formulates customized development plans both growing strengths and addressing skill gaps & ensured hiring, training, on-boarding, and development of personnel with focus on operational excellence.

• As Clinical Operations Head , accountable for delivery of clinical studies in India and Pakistan in pharma & vaccines with high quality & in full compliance with GSK SOPs, ICH GCP and any other applicable global and local regulatory and legal requirements.
• ·Ensured alignment of resources, priorities and deliverables in accordance with TAs strategy.
• Accountable for capability and talent development of 16 staff in India and 6 staff in Pakistan.
• As Data Quality Leader, led end-to-end study data quality and integrity from design through publication / submission to archiving.

• Effectively managed Phase 1-4 global and local clinical trials in India & Bangladesh - in oncology, anti-infection, cardiovascular, psychiatry, neurology, osteoporosis and diabetes. This has resulted in the commercial launch of five assets - four in oncology and one in osteoporosis.
• Line management of 17 staff & development of key talent.
• Drove year-over-year business growth while leading operations, strategic vision and long-range planning.
• Developed effective business plans to align strategic decisions with long-term objectives.
• Implemented operational strategies by strong collaboration with stakeholders and employee loyalty.

• Expanded cross-functional organizational capacity by collaborating across departments on Quality-related priorities.
• Promoted Quality Standards and Process Implementations within the Medical Research Department & contributed to the successful commercialization of products, activities & services of Pfizer India.
• Conducted site and systems audits & shared key learning to build a quality culture.

• Improved performance, hiring practices and management systems to facilitate success of client's organization.
• Analyzed problematic areas to provide recommendations and solutions.
• Renegotiated outsourcing contracts with Research Institutes to save considerable costs.
• Multiple Assignments

Project Leader for a study in Major Depression with Targacept Inc.

Regional Manager – Business Development, with Manipal Acunova,

General Manager – Academics - Institute of Clinical Research (India),

Global Advisory Board & Investigator Meetings for Eisai Pharmaceuticals,

Authored a comprehensive Business Report on Clinical Research Industry and leading CROs in India, with Proximare Inc.

Safety Reporting at the Centre for Communicable Diseases for a multi-centric study in AIDS patients, Singapore.

• Clinical Operations and Process Manage r:

·Set up the Clinical Research Department In india. Recruited and trained 4 CRAS in ICH-GCP and AstraZeneca SOPs.

Managed Phase III/IV studies in cardiovascular, metabolic disorders, oncology, maternal health & infection therapy areas.

In Regional Training capacity:

Regional training to CRAs from 7 countries

Evaluated success of training programs and recommended improvements to enhance effectiveness.

Reviewed and edited all training materials for accuracy & compliance.

Coordinated technical training and personal development classes for Clinical research staff in Asia Pacific region.

• Responsible for business development, focused on Indian & multinational pharmaceutical companies & research institutes.
• Developed and implemented performance improvement strategies and plans to promote continuous improvement.
• Successfully managed 8 affiliated sites in India, initiated a phase III study in Community Acquired Pneumonia for a US client and set up operations in Chennai.

• Led a global team of 6 CRAs, successfully conducted a study in AMI for a US-based client; at 12 Indian sites, 6 sites in Singapore & Philippines.
• Successfully conducted a study on Pancreatic Cancer for a US company, and a study on Migraine in adolescent patients for a Swedish company.

• Successfully managed Phase 3-4 clinical studies on pharmaceutical products & vaccines.
• Developed local SOPs, delivered training programs on GCP for CRAs and investigators.
• Registration of new products and submission of clinical studies to the Regulatory Authority.
• Accomplished multiple tasks within established timeframes.

• Responsible for Market Support activities, Business development Field Force Training and Product Information.
• Worked in the “Finished Products” and “Microbiology”. Well versed in pyrogen testing, sterility testing, bioassays, chemical assays, HPLC, IR and Spectrophotometry.
• Learned new skills and applied to daily tasks to improve efficiency and productivity.

• Significantly contributed to “Light and Electron-microscopy of Nerve and Muscle Disorders in Man” with special emphasis on Leprous Neuritis , Diabetic Neuropathy & Protein Calorie Malnutrition. Experienced in histochemistry, immuno-histochemistry & tissue .
• Histopathology of brain tumor specimens.