プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Sherese F.に依頼

United States

Medical Affairs, Clinical Strategy Consultant, Oncology, Neuro-Oncology, Clinical Trials, Evidence, MedTech

プロフィール概要

I am a PhD-prepared Medical Affairs and Clinical Strategy leader with more than 20 years of experience spanning oncology, neuro-oncology, clinical research, medical devices, academic medicine, and healthcare innovation. My work bridges clinical science and industry strategy, with particular expertise in translating complex clinical and scientific questions into practical evidence-generation, research, and Medical Affairs plans. In my current Global Medical Affairs role, I lead medical and clinical evidence strategy for a $230M portfolio of implantable neurosurgical technologies. My experience includes clinical study design, post-market clinical evidence generation, investigator-initiated research, KOL engagement, advisory boards, scientific communications, congress strategy, literature evaluation, and development of evidence frameworks supporting regulatory and commercialization objectives. I have led research activities across more than 60 clinical trials throughout my career, with extensive experience in oncology, neuro-oncology, and CNS research. At the Lenox Hill Brain Tumor Center, I co-authored clinical trial protocols and led clinical research activities across 17 Phase I–III glioblastoma and CNS trials, including novel approaches to intra-arterial drug delivery and blood-brain barrier disruption. My responsibilities have spanned protocol development, study start-up, patient eligibility and enrollment, clinical monitoring, trial operations, data interpretation, and scientific dissemination. I have contributed to 10 peer-reviewed publications, including research published in the Journal of Neuro-Oncology, Journal of Neurosurgery, and World Neurosurgery. My broader clinical background includes hematology/oncology, bone marrow transplantation, chemotherapy, radiation oncology, neurosurgery, and neuro-oncology at major academic medical centers including Weill Cornell, Northwestern, and Lenox Hill. I have also held senior operational leadership positions, including Vice President of Clinical Operations for a digital health company and Director of Advanced Practice Nursing, where I led approximately 200 advanced practice clinicians. Areas in which I can support clients include Medical Affairs and clinical strategy, clinical evidence planning, clinical trial and protocol development and review, literature reviews and scientific analysis, KOL and advisory board strategy, investigator-initiated research, scientific communications, clinical operations, patient recruitment and trial-access strategy, oncology and CNS subject-matter expertise, and MedTech clinical strategy. My academic preparation includes a PhD in Nursing Research, an MSN as a Family Nurse Practitioner, and ongoing MPH studies at Brown University focused on population health, health outcomes, epidemiology, biostatistics, and health policy. I have also completed certificate programs in AI in Healthcare through Stanford School of Medicine and Regulatory Science through Duke University School of Medicine. I am particularly interested in consulting engagements with biotechnology, pharmaceutical, medical device, digital health, clinical research, and healthcare technology organizations seeking experienced clinical and Medical Affairs expertise to move scientific ideas toward meaningful clinical application.

専門分野

• ☆ Data Collection
• ☆ Health Policy
• ☆ Adult Education
• ☆ Curriculum Planning & Development
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Medical Imaging/Radiology
• ☆ Neurology
• ☆ Oncology
• ☆ Radiation Therapy
• ☆ Chemotherapy
• ☆ Surgical Oncology
• ☆ Precision Medicine
• ☆ Neurosurgery
• ☆ Spine Surgery
• ☆ Hematology
• ☆ Hematology-Oncology
• ☆ Public Health
• ☆ Epidemiology
• ☆ Pandemic Preparedness
• ☆ Emergency Preparedness
• ☆ Global Health
• ☆ Quality of Life Assessment
• ☆ E-Health & Telemedicine
• ☆ Healthcare Administration & Management
• ☆ Hospital & Medical Facility Management
• ☆ Medical Practice Management
• ☆ Medical Affairs
• ☆ Nursing
• ☆ Evidence Based Nursing
• ☆ Oncology Nursing
• ☆ Nursing Administration & Management
• ☆ Nursing Education
• ☆ Neurosurgical Nursing
• ☆ Public Health Nursing
• ☆ Nursing Research
• ☆ Neuro-Oncology
• ☆ Neuroradiology
• ☆ Endovascular Neurosurgery
• ☆ Product Launch Support
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ Feasibility Studies
• ☆ Literature Search
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Medical Writing, General Proofreading & Editing

Research Market Research, User Research, Feasibility Study, Systematic Literature Review

Consulting Business Strategy Consulting, Healthcare Consulting, Operations Consulting, Regulatory Consulting

職務経験

Global Medical Affairs

Integra LifeSciences

1月 2022 - 現在

Vice President Clinical Operations

Trellus Health

1月 2021 - 1月 2022

Director Clinical Research/Advanced Practice

Lenox Hill Hospital

8月 2014 - 1月 2021

Neurooncology Nurse Practitioner

Northwestern University

8月 2011 - 8月 2014

Neurooncology/Neurosurgery NP

Weill Cornell Neurosurgery

3月 2009 - 8月 2011

Hematology Oncology Nurse

NY Presbyterian Weill Wornell

8月 2002 - 3月 2009

学歴

MPH

Brown University

1月 2026 - 現在

PhD

Nova Southestern Universoty

8月 2019 - 4月 2024

BSN

The University of Michigan

8月 1997 - 8月 2002

認定資格

• Chemotherapy Biotherapy Provider

  ONS

  1月 2012 - 現在

• Family Nurse Practitioner

  ANCC

  5月 2009 - 現在