Jyoti Nehra
Milford
Summary
Strategic clinical research leader with over 10 years in clinical development and 6 years in pharmaceutical leadership. Expertise in directing global late and early oncology R&D programs, focusing on small molecule inhibitors, ADCs, and immuno-oncology. Proven ability to drive clinical strategy, regulatory alignment, and innovative trial designs, ensuring effective dosing strategies and compliance. Track record of steering complex global programs to achieve decisive milestones with operational excellence.
Overview
10
10
years of professional experience
Work History
Medical Director, Late Oncology R&D
AstraZeneca
Waltham
07.2024 - Current
- Lead strategic clinical development initiatives in late-stage oncology, clinical development plans (CDPs), and target product profiles (TPPs).
- Lead interactions with global regulatory functions and health authorities, preparing for and participating in FDA meetings to align clinical program strategies.
- Oversee complex clinical trials, ensuring regulatory compliance while managing risk-benefit assessments and maintaining rigorous scientific standards.
- Manage safety surveillance (adverse events) as medical expert/monitor, preparing regulatory documents to ensure compliance and support decision-making.
- Cultivate relationships with consultants and key external experts (KEEs) to gather feedback on protocol design and execution, enhancing study relevance and validity.
Medical Director, Early Oncology R&D
AstraZeneca
Waltham
11.2022 - 07.2024
- Spearheaded Project Optimus initiatives, advancing innovative approaches to dose optimization in oncology research.
- Directed clinical planning and trial development for novel anticancer agents, including ADCs and small molecular inhibitors, to enhance therapeutic strategies.
- Partnered with Clinical Pharmacology teams to design critical studies on drug interactions, food effects, and QT analysis.
- Established scientific protocols for clinical trials and managed data collection systems, ensuring regulatory compliance and data integrity.
Associate Medical Director, Early Oncology R&D
AstraZeneca
Mississauga
08.2021 - 11.2022
- Led early oncology trial designs (Phase I/II) with robust pharmacology integration, patient selection strategies (e.g., biomarker‑enriched cohorts), and operational risk controls; served as medical monitor and scientific point of contact for investigators and vendors.
- Advanced cross‑functional deliverables, including protocol/amendments, CRFs, and vendor specs; ensured timely database lock and topline reporting while contributing to publications and scientific congress presentations.
- Analyzed clinical trial data to guide strategic decision-making.
Clinical Research Scientist
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
Blue Bell
09.2020 - 08.2021
- Spearheaded clinical trial development with diverse teams, enhancing early oncology R&D processes.
- Designed Phase I-II trials, presenting insightful data to senior stakeholders.
- Directed protocol development and endpoint strategies while ensuring regulatory compliance.
- Led medical monitoring activities, developing plans and providing oversight for protocol execution.
- Assessed patient eligibility and safety to improve trial integrity and outcomes.
- Conducted patient assessments and monitored safety protocols throughout trials.
- Cultivated relationships with oncology leaders, strengthening research collaborations and study design.
- Coordinated IRB/IEC submissions with clinical sites, facilitating timely approvals for study initiation.
Medical Research Fellow
Canadian Cancer Trials Group, Queen's University
Kingston
10.2018 - 09.2019
- Designed Phase I-II trials, presenting data insights to senior stakeholders effectively.
- Led clinical trial development with diverse teams, enhancing early oncology R&D processes.
- Orchestrated patient eligibility assessments and safety monitoring protocols, fostering collaboration with principal investigators.
- Assessed patient eligibility and safety, ensuring trial integrity and enhancing patient outcomes.
- Cultivated relationships with oncology leaders, facilitating stronger research collaborations.
Oncotherapeutics Fellow
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) - TATA
Kharghar
09.2017 - 09.2018
Senior Resident
Pt. B.D. Sharma Post Graduate Institute of Medical Sciences
Rohtak
09.2016 - 09.2017
Education
Certified Clinical Research Professional (CCRP) -
Queen's University
Kingston, Ontario08-2019
DNB - Clinical Pharmacology
National Board of Education
New Delhi, Delhi09-2018
MD - Clinical Pharmacology
Pt.B.D. Sharma PGIMS
Rohtak, Haryana08-2016
MBBS -
Sikkim Manipal Institute of Medical Sciences
Gangtok, Sikkim03-2012
Skills
- Clinical leadership
- Dose optimization
- Safety monitoring protocols
- Oncology drug development
- Team leadership
- Protocol development
- Regulatory compliance
- Research analysis
- Clinical strategy
- Antibody-drug conjugates
- Medical monitoring
- Immuno-oncology
Awards
- Sonal Vora Award for Best Woman Presenter
- Travel scholarship for 2018 Australia and Asia Pacific Clinical Oncology Research Development Workshop from National Cancer Institute (NCI), USA
- Dr. U.K. Seth Award as first prize for Oral presentation
- Venus International Healthcare awards 2018- Young Researcher in Pharmacology
Websites
Timeline
Medical Director, Late Oncology R&D
AstraZeneca
07.2024 - Current
Medical Director, Early Oncology R&D
AstraZeneca
11.2022 - 07.2024
Associate Medical Director, Early Oncology R&D
AstraZeneca
08.2021 - 11.2022
Clinical Research Scientist
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
09.2020 - 08.2021
Medical Research Fellow
Canadian Cancer Trials Group, Queen's University
10.2018 - 09.2019
Oncotherapeutics Fellow
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) - TATA
09.2017 - 09.2018
Senior Resident
Pt. B.D. Sharma Post Graduate Institute of Medical Sciences
09.2016 - 09.2017
Certified Clinical Research Professional (CCRP) -
Queen's University
DNB - Clinical Pharmacology
National Board of Education
MD - Clinical Pharmacology
Pt.B.D. Sharma PGIMS
MBBS -
Sikkim Manipal Institute of Medical Sciences