Dharam T. Email & Phone Number

California, United States

Emeryville, California, United States

Foster City, California, United States

• Responsible for management and execution of Clinical Pharmacology strategies to mitigate risks and support development of drug candidates across all phases of development, through facilitation of Clinical Pharmacology.
• Represents the ClinPharm functional team across various cross functional and stakeholder meetings, relaying key decisions and driving discussions to meet global regulatory requirements and timelines.
• In collaboration with stakeholders, business process owners, and subject matter experts from different functions, currently leading to support 3 regulatory submissions by creating timelines, defining project.
• Translate business needs into projects and initiatives; define and communicate business and financial benefits of projects and initiatives. Currently working on developing a playbook for future development.

Brisbane, California, United States

• Provide operational support to the Bioanalytical group and work with preclinical and clinical study teams, vendor management and performance, Clinical data group, central labs and SMT to outsource and manage biosample.
• Driving the development of assay vendor SOWs, managing vendor contracts, including review of invoices, ensuring receipt of SOW deliverables, resolving or escalating issues where needed, and closing contracts.
• Develop timelines for PK/ADA/biomarker data for managing contract labs to ensure samples are tested according to protocol/team timelines, data are returned in the specified format, and all SOW specified deliverables.

Redwood City, CA

• Support all internal and external bioanalysis efforts for preclinical and clinical studies, including biological activity, biomarker analysis and pharmacokinetics.

South San Francisco, California

• Collaborate with Amgen’s Pharmacokinetics and Drug Metabolism (PKDM) department on the discovery and development of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion.
• Working closely with disciplines, such as protein science, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology, and regulatory to engineer promising clinical therapeutic candidates, conduct.
• Designing and executing experiments to quantitate molecular entities by immunoassay (ELISA, Gyros, MSD, Luminex, Quanterix) in support of both drug discovery and early development programs of new protein/mAb entities.
• Data generation and analysis with Watson-LIMS, and proficiency with Graphpad, smartsheet, excel, powerpoint, phoenix winnonlin.

Greater San Diego Area

• Research Scientist
• Expertise in directing the development and validation of Immunogenicity, PK and Biomarker assays in support of GLP and non-GLP studies and use of relevant modules and functions for the Biomarker and Immunoanalytical.
• Maintained PO, contracts, budgets, revenue, and forecast schedules for multiple projects; setting priorities to maximize timeline completions for smooth business operations.
• Reviewed client proposals and contracts, drafted Project Plans and Final Reports.
• Understanding sponsor priorities and business needs, along with the supplier capabilities and process.
• Resolved technical issues to ensure minimal interruptions in workflow to complete study milestones.

• Support the process development and commercialization of protein-based therapeutics in the Bioassay and Biological Characterization Group by developing and implementing in-vitro bioassays, reporter gene potency assays.

• Worked as an R&D intern to assess the impact of Probiotics on Caco-2 cell lines and Clostridium difficile. The responsibilities include leading technical design and developing and applying in-vitro methods to test the.

Ms, Molecular Microbiology And Immunology

Activities and Societies: ASM

Master'S Degree, Microbiology, General

Bachelor'S Degree, Microbiology, General