Deepak Chilkoti Email & Phone Number

Gurugram, Hr, In

Gurugram, Haryana, India

- Manage subject safety and the scientific integrity of clinical trials.- Responsible for subject-safety and the scientific integrity of clinical trials.- Participate in bids, bid-defenses & feasibility assessments when requested.- Provide project-specific and therapeutic training to sponsors and Company staff as needed.- Work with the Drug Safety Department by providing medical input and oversight.- Work with Medical Writing/Regulatory in the preparation of a variety of documents as required.- Maintain in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines.- Interact with senior management, project management, and other departments as appropriate.- Provide clinical development and regulatory consulting advice both within Company and to clients as requested.- Locate and interact with outside experts as necessary.

Gurgaon, India

- Manage subject safety and the scientific integrity of clinical trials.- Responsible for subject-safety and the scientific integrity of clinical trials.- Participate in bids, bid-defenses & feasibility assessments when requested.- Provide project-specific and therapeutic training to sponsors and Company staff as needed.- Work with the Drug Safety Department by providing medical input and oversight.- Work with Medical Writing/Regulatory in the preparation of a variety of documents as required.- Maintain in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines.- Interact with senior management, project management, and other departments as appropriate.- Provide clinical development and regulatory consulting advice both within Company and to clients as requested.- Locate and interact with outside experts as necessary.

New Delhi Area, India

- Supervision of clinical operations and medical monitoring activities for Pharmaceuticals and vaccine products.- Work collaboratively with cross functional teams including regulatory affairs, medical writing and biostatistics.- Responsible for the medical monitoring of clinical trials.- Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company SOPs, ICH GCP guidance and study protocol.- Performs oversight of trial to ensure that safety concerns and/or adverse events/ SAEs are properly tracked and reported. - Overview of Literature Surveillance Activities - Decision Matrix for ICSR Reporting and Distribution- Identifying various potential safety alerts/signals - part of signal detection team- Ensuring Regulatory Compliance-Clinical Trial Safety Reporting- Monitoring and coordination with external agencies i.e. contract research organizations for carrying out pharmacovigilance studies- To impart pharmacovigilance training of staff members and associates - To impart training to sales and marketing team for carrying out the pharmacovigilance activity for marketed products.

Ahmedabad Area, India

Executed following Clinical trials in India, Asia Pacific & Europe:Non Alcoholic Fatty liver Disease (NAFLD/ NASH)Non Small Cell Lung Cancer (NSCLC)Diabetic MellitusDyslipidemiaHIV- Lipodystrophy

Greater Noida, Ncr, India

Lead the clinical operations and medical scientific affairs team for global clinical development of NCEs, Working closely with the global teams across US and EU towards setting up clinical operations systems and processes and ensuring key deliverables across various functions and domains.

Faridabad Area, India

• Heading team size of 30 + under different verticals of Clinical Operations: Feasibilty, Medical Writing, Operations (Early and Late Phase) and Regulatory • Review Study budgets and proposals to be sent to prospective sponsors and coordinate study feasibility activities with the Medical Affairs team.• Mentor, coach and train team members and ensure adherence to GCP guidelines and SOPs.• Regulatory Submission & Approvals - Responsible for clinical trials regulatory approval process (India) and ensuring regulatory compliance for clinical trials and studies • Pharmacovigilance - Ensuring Adverse Event Review and Reporting for the clinical trials and studies• Track study progress and milestones; regulate quality standards; resolve logistic and practical issues and promote the team-working environment.

New Delhi Area, India

Leading a group of medical /life sciences professionals and medical writers handling diverse areas.Ensuring overall smooth functioning of the 30 bedded CPU for conduct of BE studies in healthy volunteersLooking after the Medical affairs as therapeutic area physician and responsible for training and medical information.

Faridabad Area, India

Clinical and medical support to the Pharmacokinetic and Bio-equivalence (BA / BE) studies on generic productsTo interact with Ethics Committee and get approval for the clinical studiesTo ensure that the studies are carried out as per protocol and applicable regulatory requirements of GCP

New Delhi Area, India

Project manager for Post marketing study on Antitubercular drug for WHO submission.Working on the clinical development plans and strategies for Vaccines.

New Delhi Area, India

Experimental research work/projects, Teaching MD, MBBS and Nursing studentsCollection of Adverse Events (AE) from peripheral centers and forwarding to zonal center AIIMS after causality assessment.