Anjali Sharma
+91-9876543210 | anjali.sharma@email.com | 42 Maple Ridge Lane, Bangalore, Karnataka 560034 | linkedin.com/in/anjalisharma-md

EXECUTIVE SUMMARY

Board-certified physician and strategic medical leader with 15+ years of experience in pharmaceutical and biotechnology industries. Proven expertise in clinical development strategy, regulatory affairs, and medical affairs operations with focus on immunology and rheumatology. Track record of successfully leading global clinical trial programs from Phase I through commercialization, with particular emphasis on autoimmune diseases and translational research initiatives.


PROFESSIONAL EXPERIENCE

Executive Medical Director
Immunova Therapeutics, Boston, Massachusetts
January 2021 – Present

• Lead global medical strategy and clinical development programs for immunology portfolio, overseeing $250M+ annual budget across 12 active clinical trials in rheumatoid arthritis, lupus, and inflammatory bowel disease
• Direct cross-functional team of 45+ medical affairs professionals, clinical scientists, and medical science liaisons across North America, Europe, and Asia-Pacific regions
• Established translational research framework integrating biomarker discovery with clinical trial design, resulting in 40% improvement in patient stratification and enrollment efficiency
• Serve as primary medical liaison with FDA, EMA, and PMDA for regulatory submissions, achieving successful approval of two novel biologics for autoimmune indications
• Drive medical affairs strategy including scientific communications, advisory boards, and key opinion leader engagement programs supporting product lifecycle management

Senior Medical Director, Immunology
Synergex Pharma Solutions, San Francisco, California
March 2017 – December 2020

• Directed clinical development strategy for Phase II-III programs in rheumatology, managing portfolio of 8 clinical trials with 3,500+ patients across 25 countries
• Led medical monitoring and safety oversight activities, implementing risk management strategies that reduced serious adverse event reporting time by 35%
• Collaborated with regulatory affairs to prepare IND, NDA, and BLA submissions, contributing to successful approval of first-in-class therapy for systemic lupus erythematosus
• Developed and executed publication strategy resulting in 18 peer-reviewed manuscripts in high-impact journals and 40+ congress presentations
• Mentored team of 6 medical directors and clinical scientists in protocol development, data interpretation, and regulatory interactions

Associate Medical Director
Helix Biotech Inc., New Jersey
June 2013 – February 2017

• Managed clinical operations for Phase I-II studies in autoimmune diseases, overseeing protocol design, site selection, and enrollment strategies
• Served as medical monitor for 5 concurrent clinical trials, conducting regular site visits and ensuring compliance with GCP and regulatory requirements
• Contributed to clinical development plans and investigator brochure updates based on emerging safety and efficacy data
• Collaborated with biostatistics and data management teams to design analysis plans and interpret clinical trial results
• Supported regulatory submissions through preparation of clinical summaries and responses to health authority questions

Clinical Research Physician
Apollo Clinical Research Center, New York, New York
July 2010 – May 2013

• Conducted clinical research in rheumatology and immunology, serving as sub-investigator on 12 industry-sponsored clinical trials
• Performed patient screening, enrollment, and follow-up assessments according to protocol requirements
• Documented adverse events and ensured accurate medical reporting in compliance with regulatory standards
• Participated in investigator meetings and contributed to protocol amendments based on clinical insights
• Collaborated with sponsors on feasibility assessments and site capability evaluations


ACADEMIC BACKGROUND

Doctor of Medicine (M.D.)
All India Institute of Medical Sciences, New Delhi
Graduated: 2004

Residency in Internal Medicine
Christian Medical College, Vellore
Completed: 2007

Fellowship in Rheumatology
St. John's Medical College, Bangalore
Completed: 2010

Bachelor of Science in Biochemistry
University of Delhi, Delhi
Graduated: 2000


BOARD CERTIFICATIONS & LICENSES

• American Board of Internal Medicine – Internal Medicine (2007)
• American Board of Internal Medicine – Rheumatology (2010)
• Active medical license in Massachusetts


SKILLS

Clinical Development: Clinical trial design and execution, protocol development, medical monitoring, safety surveillance, risk management, investigator relations

Therapeutic Expertise: Rheumatology, autoimmune diseases, immunology, inflammatory conditions, translational medicine

Regulatory Affairs: IND/NDA/BLA submissions, FDA/EMA interactions, regulatory strategy, medical writing, clinical study reports

Research Capabilities: Clinical research methodology, translational research, biomarker development, data interpretation, evidence synthesis

Leadership: Cross-functional team leadership, strategic planning, budget management, talent development, stakeholder engagement


PUBLICATIONS & PRESENTATIONS

• Author or co-author of 35+ peer-reviewed publications in journals including New England Journal of Medicine, The Lancet, Annals of Rheumatic Diseases, and Arthritis & Rheumatology
• Presented at major medical conferences including ACR, EULAR, AAD, and FOCIS
• Contributed to clinical practice guidelines for management of autoimmune diseases


PROFESSIONAL AFFILIATIONS

• American College of Rheumatology (ACR)
• American College of Physicians (ACP)
• Drug Information Association (DIA)
• American Society of Clinical Pharmacology and Therapeutics (ASCPT)