Anup Choudhury
Medical Director, Global Clinical Development @Novartis
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WORK HISTORY
Medical Director, Global Clinical Development @Novartis
Hyderabad, IN
Clinical leadership and strategic guidance for all clinical programs• Leading development of clinical sections of trial and program level regulatory documents (e.g, Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)• Driving execution of the section of the clinical program in partnership with global line functions• Ensuring ongoing medical and scientific review of clinical trial data • Acting as study medical monitor: ensuring overall safety of the molecule • Leads the Global Clinical Team, represents the section when needed in Global Program Team meetings; and as the section spokesperson in internal and external meetings/boards• Ensures career development of Function and Program reports and other clinical colleagues
EDUCATION
Asaam Medical College
MBBS, Medicine
Sikkim Manipal Institute of Technology - SMU
MBA, Healthcare Services
HMX – Harvard Medical School
HMX Pro-Gene Therapy, Genetics - Gene Therapy
Harvard Medical School
HMX Pro Immunology - Immuno-oncology
Assam Medical College
MD(Pharmacology), Clinical Pharmacology and Therapeutics
ABOUT ANUP CHOUDHURY
Clinical development #medical director #Medical safety leader #clinical trial and #drug safety #pharmacovigilance #Clinical pharmacologist A dynamic medical professional: MBBS, MD clinical pharmacology and MBA (healthcare services), total 19 years of work experience (9 years in Pharma industry, and 10 years clinical practice) Areas of expertise: 3½ years in global clinical development and 5½ years in global drug safety and pharmacovigilance. Specific strength or experiences: clinical trial protocol development, medical monitoring, benefit-risk evaluation, heath authority interactions, briefing book/dossiers preparation for FDA Advisory Committee and EMA, PRAC assessment reports e.g. article 31 referrals, preparation of submission package; clinical overviews (CO), clinical expert statement, summery of clinical efficacy and clinical safety (type 2 variation SPC update ), clinical study reports (CSR), scientific abstracts, presentations, and manuscripts for journals. Company Core Data Sheet (CDS) and Investigator Brochure (IB) updates, periodic safety reports (PBRER, PSUR, DSUR), Development Safety Profiling Plans (DSPP) and Risk management plans (RMP), signal detection and evaluation, literature reviews etc. Proven ability to work under global teams in matrix environment for complex decision making, project management, networking and leadership skills to lead cross functional teams, ability to work under pressure situations to achieve target/timeline
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