Summary
Overview
Work History
Education
Skills
Certification
LANGUAGES
Timeline
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Nasim Babakhodaverdi

Summary

Experienced clinical director and pharmacist with over 10 years of progressive expertise in clinical research operations, regulatory affairs, and clinical team leadership, with a strong focus on clinical trial management, clinical supply oversight, and cross-functional collaboration. Adept at developing and implementing clinical protocols, managing clinical supply logistics, and creating training materials for clinical trial sites and CROs. Skilled in gene therapy and rare disease research. Committed to advancing clinical trial excellence and supporting the development of novel therapies in alignment with organizational and regulatory standards.

Overview

9
9
years of professional experience
1
1
Certification

Work History

CLINICAL TEAM LEAD

Mehregan Specialist Hospital
05.2015 - 05.2020
  • Led the implementation of medical strategies and decisions, resulting in improved disease management and drug safety through adherence to AEs/SAEs guidelines and SOPs.
  • Facilitated cross-functional team discussions to reduce adverse events, enhance patient safety, and achieve quality outcomes in clinical research, including rheumatology and immune-mediated disease trials.
  • Contributed to the development and review of study-related documentation and protocols, ensuring alignment with trial objectives and regulatory standards.
  • Developed and implemented internal processes and regulations to support clinical trial operations and ensure compliance with national and international guidelines (GCP, ICH).
  • Planned and executed over 30 Cardiovascular educational workshops for healthcare professionals, utilizing current clinical data to improve prescription confidence and clinical outcomes.

CLINICAL DEVELOPMENT DIRECTOR

Alborz Darou Pharmaceutical Industry
05.2013 - 05.2015
  • Facilitated cross-functional collaboration to support clinical trial execution, data integrity, and alignment with global strategy.
  • Managed relationships with over 50 healthcare professionals to support clinical research and product understanding and development in immunology and related therapeutic areas.
  • Contributed to the review and interpretation of clinical data, supporting medical monitoring and protocol adherence.
  • Supported the development and review of study materials and documentation.
  • Designed and executed experiments, analyzed primary data, and provided actionable insights to inform clinical operations and product development.
  • Implemented a Key Opinion Leader mapping process, increasing engagement impact by 50% and supporting strategic alignment across teams.
  • Initiated compliance training programs that reduced potential regulatory risks by 65%.
  • Delivered timely data and documentation for new tests, supporting research and development activities.
  • Provided up-to-date clinical studies and insights to ensure adherence to company standards and regulatory expectations.

PHARMACIST AND MANAGER

Dr. Babakhodaverdi's Pharmacy
07.2012 - 10.2020
  • Led clinical teams in managing operational aspects of pharmacy and clinical services, including timelines, budgets, and quality targets, ensuring alignment with regulatory requirements and SOPs.
  • Streamlined workflow processes, resulting in a 35% increase in efficiency and consistent achievement of key performance indicators for clinical operations.
  • Supervised and mentored a diverse team of pharmacy technicians and interns, fostering a collaborative environment and promoting continuous improvement and talent development.
  • Coordinated logistics for medication deliveries, maintaining compliance with regulatory standards and enhancing patient safety protocols.
  • Oversaw resource allocation and deployment to support optimal team performance and timely patient care.

REGULATORY AFFAIRS PHARMACIST

Food and Drug Administration
05.2011 - 05.2013
  • Prepared and submitted regulatory file applications and supporting documentation for clinical trials and pharmacy operations.
  • Reported investigation results with detailed written observations and photographs, producing comprehensive final reports.
  • Provided regulatory guidance and training to pharmacy teams, supporting compliance with evolving policies and procedures.
  • Compiled and maintained regulatory documentation databases and systems, ensuring accuracy and compliance with local and international regulations.

Education

Master of Science - Clinical Research Management

MCPHS University
Boston, MA
12.2022

Doctor of Pharmacy (PharmD) - Pharmaceutical Science

Islamic Azad University
Tehran, Iran
02.2011

Skills

  • Regulatory Compliance (FDA, HIPAA)
  • Knowledge of legal frameworks
  • Statistical Analysis
  • Safety Review (AEs/SAEs)
  • CRO/Vendor Management
  • Risk Management & Mitigation
  • Stakeholder Communication
  • Budget Analysis & Cost Evaluation
  • Drug Development & Discovery
  • GCP/GMP

Certification

  • Innovation in Medical Product Development, FDA, May 2024-Present
  • Regulatory Education For Industry, FDA, May 2024-Present
  • HIPS, CITI Program, December 2022-Present
  • Biomedical Chart Reviews, CITI Program, December 2022-Present
  • Training Drug Discovery Development, Pfizer, December 2021-Present

LANGUAGES

English (Fluent)
German (Conversational)
Persian (Native)

Timeline

CLINICAL TEAM LEAD

Mehregan Specialist Hospital
05.2015 - 05.2020

CLINICAL DEVELOPMENT DIRECTOR

Alborz Darou Pharmaceutical Industry
05.2013 - 05.2015

PHARMACIST AND MANAGER

Dr. Babakhodaverdi's Pharmacy
07.2012 - 10.2020

REGULATORY AFFAIRS PHARMACIST

Food and Drug Administration
05.2011 - 05.2013

Master of Science - Clinical Research Management

MCPHS University

Doctor of Pharmacy (PharmD) - Pharmaceutical Science

Islamic Azad University

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Nasim Babakhodaverdi