Rajula Gaur
Scientific Associate DirectorClinical Development & Translational Strategy | Biomarker & Target Engagement Strategy (Pharmacodynamic Assessment) | External Vendor Management (CROs) | Regulatory Document Contributions
- Role
- Scientific Associate Director at Bristol Myers Squibb
- Location
- Hillsborough, NJ, US
- LinkedIn followers
- 500 followers
About Rajula Gaur
Lead Scientist with comprehensive expertise in clinical and translational settings, specializing in the identification and implementation of pharmacodynamic biomarkers. Proven track record in validating biomarkers for clinical studies, supporting target credentialing in multiple disease indications including rheumatology, inflammatory bowel disease, multiple sclerosis, chronic obstructive pulmonary disease, and exploring mechanisms of action of lead compounds. Expertise includes:• Leading biomarker programs in early clinical studies for drug targets in Immuno-Inflammatory diseases• Establishing pharmacodynamic (PD) biomarker and target engagement assays for early clinical trials in healthy volunteers and patients • Experience leading without authority and in muti-functional matrixed and global environments• Managing interactions with internal teams and external vendors (CROs) for biomarker assay transfer and validation• Developing strategic plans for patient stratification using biomarker assays for clinical development projects• Collaborating across multiple research areas for Immuno-Inflammation including inflammatory bowel disease, rheumatology diseases, multiple sclerosis, COPD and IPF.• Possessing versatile management skills with the ability to communicate effectively with internal and external partners
Experience
Scientific Associate Director
Nov 2015 — Present · Summit, NJ, US
Led biomarker efforts for programs in development within the Immunosciences Thematic Research Center, focusing on IBD, RA, and COPD.• Analyzed biomarker data from novel pharmacodynamic assays in early clinical studies to assess PK/PD relationships and contributed to dose escalation decisions • Managed interactions with external partners (CROs, clinical sites) for biomarker assay validation and transfer, and assisted in writing non-clinical pharmacology study reports and PD sections of clinical protocols• Contributed to IB, IND, CSR, and clinical study protocols• Designed novel assays for validating pharmacodynamic markers for targets in early development
Education
Mount Mary High School
SSC
1968 — 1978
The University of Akron
Ph.D, Biochemistry
1988 — 1993
Mithibai College
BSc, Chemistry
1979 — 1983
Skills
- Biomarkers
- Drug Discovery
- Cell
- Biochemistry
- Immunology
- Assay Development
- Antibodies
- Pharmaceutical Industry
- Cell Based Assays
- Translational Medicine
- Life Sciences
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