Neda S Pelar, Ph.D., Pmi Email & Phone Number

Irvine, CA, US

I am partnering with H&H as a Clinical Relations and Project Management VP.https://healthnheaven.com

• Develop comprehensive project plans with clear timelines, milestones, resources, and budgets, ensuring timely delivery within State of California and Federal regulations.
• Establish strong stakeholder relationships through regular communication updates and clear communication channels.
• Monitor project performance, identify gaps, and recommend improvements aligned with company values.

Garden Grove, California, US

• Directed a high-performing protein chemistry team for allergen production supporting allergy diagnostics.
• Ensured regulatory compliance with GMP, QSR, EH&S, FDA & ICH regulations and constrains.
• Assisted in preparing and submitting FDA, Due Diligence, POC, 21 CFR 820, ISO 13485, 510K, IVDD, and IVDR documentation for NOVEOS and NOVEOS flex diagnostics platforms.
• Achieved project milestones within established timeframes and budget through close cross-department collaboration.
• Implemented interdepartmental strategies (Chemistry, QC & Manufacturing) by identifying procedural gaps and discrepancies, improving efficiency and quality.
• Negotiated and onboarded qualified vendors, reducing monthly costs by 30%.

Irvine, CA, US

• Planned and executed method development and validation for API/DS and DP in a cGMP environment, adhering to ICH and FDA regulations.
• Delivered departmental performance goals, ensuring consistent revenue flow.
• Served as SME, guiding project managers and collaborating with cross-functional teams to meet milestones within budget and schedule.
• Prepared quality technical documentation, conducted complex testing, and provided data analysis for stakeholder presentations.
• Managed an annual department budget of $100K for equipment, software, and resources.

• Managed all aspects of the project management process from planning to closure
• Contributed to the commercialization of a PEGylated nanopeptide drug delivery agent from feasibility to pre-commercialization
• Planned drug delivery lab projects, including contracts, scope of work, documentation, and resource forecasting
• Monitored project progress and provided regular updates to upper management
• Facilitated business development meetings with internal and external stakeholders and contractors using virtual communication tools
• Identified project risks and developed mitigation strategies with team members

Orange, CA, US

• Led multiple research projects with cross-functional teams, securing a $250K NIH grant and obtaining Health Department approval.
• Designed and executed innovative drug delivery research, ensuring projects were completed within scope and on time.
• Managed project documentation, including SOPs, protocols, and manuscripts, ensuring regulatory compliance with FDA, EH&S, and OSHA standards.
• Provided mentorship and training to graduate students and lab personnel, fostering a collaborative and high-performing team environment.
• Monitored and maintained lab equipment functionality through collaboration with vendors, ensuring project continuity and efficiency.

US

• Led prostate cancer and NF-KB pathway projects, coordinating with cross-disciplinary teams to achieve key research milestones.
• Secured a $50K DOD grant through effective communication and collaboration with the grant-writing team, contributing to the project's financial success.
• Developed and maintained a strong understanding of regulatory standards (cGMP, GLP, GDP, ICH, ISO, CFRs), ensuring compliance in all project phases.
• Fostered a collaborative environment, leveraging interpersonal skills to optimize team performance and project outcomes.
• Contributed specialist input and insights to research activities, driving innovation and achieving research goals.
• Engaged in scientific research on multiple projects, collaborating with interdisciplinary teams to drive innovations.

• Conducted eight successful mutations on the LPL gene, contributing to potential treatment developments.
• Performed comprehensive literature reviews to inform study design and methodology, ensuring alignment with project objectives.
• Mastered complex molecular biology techniques, providing valuable contributions to research initiatives.

• Evaluated the clinical drug development process from preclinical to phase III to marketing;
• Inspected and reported the reasons for failure of 10 drugs developed in phase II and III;
• Knowledgeable to design successful drug development plans by considering well-proposed hypotheses, biomarkers, methodologies, therapeutic PK/PD, target modulation, dose response, exposure response, and in vitro /in.
• Contributed to a non-profit organization, MRF, in accelerating time to market for new medicines.

Brasília, Distrito Federal, BR

Pioneered the development and validation of magnetite nanoparticles (PAMF) as a biocompatible and versatile cancer drug delivery system. Innovative Problem-Solver: - Successfully saved six months of experimental work during a university-wide power outage by quickly coordinating with other departments, securing alternate lab space, and maintaining the.

• Provided full-scope midwifery care to women and neonates in hospital and at home;
• Provided counseling and psycho-socio-emotional support;
• Assisted with CQI program and initial set-up of two women centers for full-scope midwifery services and a center for Labor-Delivery-Recovery-Postpartum operation;
• Successfully implemented educational public workshops, seminars, and presentations in order to increase women and targeted population general health, diseases, and prevention awareness;
• Supervised the patient’s care team, identified, planed, implemented and evaluated the nursing care requirements for patients.

Doctor Of Philosophy - Phd, Molecular Pthology/Nanomedicine/Cancer Treatment/Drug Delivery Systems

Msc, Nanobiotechnology/Molecular Pathology

Bsc, Nurse-Midwife

Certificate, Program Management