Arindam Pal
Director, Clinical Development
- Role
- Director Clinical Development at Azurity Pharmaceuticals
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Arindam Pal
With a strong background in clinical development (study designing, PK/PD analysis, modelling & simulations & applied biostatistics) of over 18 years, I work right from concepts’ ideation, validation, clinical development, leading them to regulatory submissions.This involves in-vivo transitions from drug development involving PoC (preclinical, ex-vivo, in-silico models and clinical) to clinical phases (2-3). I worked in toxicology program to FIH (sentinel dose) studies.My role also involves KoL engagements and external/internal collaborations.I have good hands-on experience in Phoenix NLME, Winnonlin & IVIVC toolkit. Basic experience in NONMEM. Fair experience in GastroPlus. Working with R and still learning.Well equipped with scientific and regulatory writing; have lots of experience in controlled correspondences and scientific advice meetings.Worked in:Therapeutic areas: Urooncology, Gastroenterology, Reproductive medicine and maternal healthcare, Respiratory, Dermatology, Neurology and Pain management- Dosage forms: Solid and liquid orals (IR, MR), parenterals (with and without auto-injectors), inhalation (DPI, MDI), intranasal, topical, transdermal- Clinical efficacy phases: 2-3 (superiority, non-inferiority, equivalence), organoleptic studies, device robustness studies- Study types: RCT and observational studies (RWE)- Skill sets: study designing through statistical principles, data analysis & investigations, PK modelling and simulations and exposure-response analyses, IVIVC/R, preclinical-clinical translational analysis.Exposure in RWE and survival analysis.
Experience
Director Clinical Development
Sep 2024 — Present · Hyderabad, IN
Education
Indian Institute of Management, Calcutta
Executive general management programme, General management
2013 — 2013
National Institute of Pharmaceutical Education and Research
M. Pharm, Pharmacy Practice
2004 — 2006
GCTS, Asansol
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2000 — 2004
Skills
- Medical Writing
- Pharmacokinetics
- In Vivo
- In Vitro
- Drug Development
- Hplc
- Clinical Development
- Anda
- Pharmacology
- Protocol
- Drug Delivery
- Clinical Pharmacology
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