Dominique Reed

Dominique Reed

Nonclinical Medical Writer

About

NONCLINICAL REGULATORY SCIENTIST Trained nonclinical regulatory scientist specializing in nonclinical drug development of small molecule and biological product pharmaceutical development across different therapeutic areas. Experienced Regulatory Affairs professional with a proven track record with successful investigational new drug and marketing applications across North America, UK, and Europe. Highly skilled in medical writing, data analysis, study report development/publication, regulatory application submissions (CTA, IND, NDA, and BLA), project management, and working with cross-functional teams while adhering to time sensitive deadlines. Alumni of Anschutz Medical School (SKAGGS School of Pharmacy), University of Louisville and Smith College SKILLS & PROFICIENCIES Oncology and Genetic Diseases | Pharmacology | Toxicology | Nonclinical Drug Development | Project Management | Project Liaison | Team Collaboration | Problem Solving | Scientific Communication | Regulatory / Manuscript Writing | Literature Research | Regulatory Compliance | Document Management | Sharepoint Adobe Acrobat | StartingPoint | Global Submit | DocuBridge | Veeva | GraphPad Prism, RStudio | Zoom | Microsoft: Word, Excel, PowerPoint, Outlook, OneNote, Teams Contact Info: linkedin.com/in/dominiquezreed

Country

United States

City

Durham

Industry

Biotechnology

Skill

Toxicology, Oncology, Drug Development, Regulatory Submissions, Cross-team Collaboration, Molecular Biology, Cell Culture, Research, Western Blotting, Cancer, Biochemistry, Science, Chemistry, qPCR, Genetics, Data Analysis, PCR, SAS programming, Protein Expression, Polymerase Chain Reaction (PCR)

Experience

Self Employed

Nonclinical Medical Writer

Self Employed

2024-6 - Present · 2 yrs 4 mos

Durham, North Carolina, United States

The University of North Carolina at Chapel Hill

North Carolina Health Careers Access Program Coordinator

The University of North Carolina at Chapel Hill

LinkedIn
2024-12 - 2025-11 · 1 yr

Chapel Hill, North Carolina, United States

University of Pennsylvania School of Medicine

Senior Regulatory Writer, Gene Therapy Program

University of Pennsylvania School of Medicine

LinkedIn
2022-5 - 2023-12 · 1 yr 8 mos

Philadelphia, Pennsylvania, United States

• Oversaw a diverse portfolio of early-phase development of gene therapies for rare genetic disease (lysosomal disorders) and COVID-19 indications in pediatric populations that led to the successful submission of meeting requests, meeting packages/briefing documents and INDs • Led regulatory nonclinical writing activities with high demanding milestones in collaboration with cross-functional teams to decrease over 25% of nonclinical study report backlog content to advance high-quality global regulatory submissions (CTA, CTN and IND).

Allucent

Nonclinical Scientist, Nonclinical Safety

Allucent

LinkedIn
2020-7 - 2022-5 · 1 yr 11 mos

Cary, North Carolina, United States

• Served as the lead author in multiple cross-functional drug development teams to produce high-quality nonclinical / clinical regulatory documents (meeting packages, investigator’s brochures, development plans, briefing documents, nonclinical / clinical study reports, clinical protocols, Modules 1, 2, and 4), presentations, manuscripts, and strategy documents to support early- and late-stage development of products for 13+ submissions (CTA, IND, BLA, NDA) across broad therapeutic areas (medical devices, degenerative disease, oncology, neurological, and rare genetic disorders). • Facilitated a wide array of project management activities, including weekly reporting on nonclinical authoring of eCTD sections maintenance, development of meeting agendas / minutes, lead communication of authoring milestones and stakeholder meetings with project team and / or sponsors and circulation communications (email correspondence, teleconferences, Gantt/other project trackers and kickoff meetings) for regulatory submissions.

University of Colorado Anschutz

Postdoctoral Research Fellow, SKAGGS School of Pharmacy

University of Colorado Anschutz

LinkedIn
2017-5 - 2019-8 · 2 yrs 4 mos

Aurora, Colorado

• Served as a member of a multidisciplinary team of faculty and postdoctoral fellows to design and conduct cancer chemoprevention studies and support funded research on fusion gene cancer models. • Co-authored a competitive NCI CURE fellowship application, securing funding of nearly $100K to evaluate mechanisms of chemoprevention in models of pancreatic cancer. • Authored 3 peer-reviewed publications and a book chapter describing preclinical and clinical cancer chemoprevention strategies; presented research findings at local and national conferences. • Managed communications with clinical sites, shipment of human tissue samples, inventory, and sample preparation for analysis in a Phase 2 cancer study.

CU Denver/Anschutz Postdoc Association

President

CU Denver/Anschutz Postdoc Association

LinkedIn
2019-1 - 2019-7 · 7 mos

Aurora, CO

-As President, I provided oversight for the day-to-day operations of the Postdoctoral Association (PDA), committees (Engagement, Communications, Travel Awards, PostDoc Research Day, Young Hands in Science), carried out executive board meetings, represented the Association at the annual National Postdoc Association conference and addressed any arising operational problems with PDA programming (Seminar Series, Coffee Hour Monthly Meeting, P2P, Happy Hour, Saturday Hikes) and social activities (Science Lounge). The PDA sponsors a number programs that highlight the research, scientific and/or other contributions of postdocs in the CU Denver/ Anschutz Medical Campus University community.

CU Denver/Anschutz Postdoc Association

Co-Vice President

CU Denver/Anschutz Postdoc Association

LinkedIn
2018-8 - 2018-12 · 5 mos

Aurora, Colorado

-As Co-Vice President, I assisted the President with the day-to-day operations of the Postdoctoral Association (PDA), assisted with presiding over executive board meetings in the absence of the President and addressing issues with PDA programming (Seminar Series, Coffee Hour Monthly Meeting, P2P [Postdoc to Postdoc], Happy Hour, Saturday Hikes), acted as the PDA liaison to other campus organizations and activities (Science Lounge) sponsored by the PDA to highlight research and scientific and/or other contributions of the CU Anschutz/Denver postdoc community.

CU Denver/Anschutz Postdoc Association

Co-Chair of PDA Seminar Series

CU Denver/Anschutz Postdoc Association

LinkedIn
2017-9 - 2018-7 · 11 mos

Aurora, CO

The University of Colorado Anschutz Medical Campus Postdoctoral Association (PDA) hosts a seminar series for post-doctoral fellows to present their work on a variety of topics to a diverse audience and receive constructive and helpful feedback to improve their presentation skills.

CU Denver/Anschutz Postdoc Association

Co-Chair of PDA Travel Awards

CU Denver/Anschutz Postdoc Association

LinkedIn
2017-9 - 2018-7 · 11 mos

Aurora, CO

The University of Colorado Anschutz Postdoctoral Association (PDA) has a travel award fund which post-doctoral fellows can apply to for travel support to training and conference opportunities.

American Society for Pharmacology and Experimental Therapeutics - ASPET

Young Scientist Committee Representative

American Society for Pharmacology and Experimental Therapeutics - ASPET

LinkedIn
2016-5 - 2019-6 · 3 yrs 2 mos

-Served as a graduate student and postdoc representative on the American Society of Pharmacology and Experimental Therapeutics Young Scientist Committee. This committee is dedicated to providing creative professional development, outreach and networking opportunities for undergraduates, graduates and post-doctoral fellows.

American Society for Pharmacology and Experimental Therapeutics - ASPET

Mentoring and Career Development Committee Graduate Student Representative

American Society for Pharmacology and Experimental Therapeutics - ASPET

LinkedIn
2015-7 - 2016-6 · 1 yr

-Served as a graduate student representative on the American Society of Pharmacology and Experimental Therapeutics Mentoring and Career Development Committee. The committee was dedicated to providing a holistic career development experience for graduate and post-doctoral trainees, which includes but not limited to community outreach, a research symposium about mentoring, essential skills for trainees, lectures, poster presentations and a diversity breakfast lecture series.

University of Louisville

Doctoral Fellow

University of Louisville

LinkedIn
2011-8 - 2016-5 · 4 yrs 10 mos

Louisville, Kentucky Area

Master's Thesis: Investigated inflammatory and immune response-associated genetic variants (Toll-like receptors, Chemokines, Cytokines) that modify prostate cancer risk among men of African descent and microRNA signatures that may serve as potential prostate cancer biomarkers to identify aggressive versus non-aggressive disease using dry lab techniques such as SAS programming, Linux Operating system coding, in silico tools (Ingenuity, MetaCore), SNP Variation and Multi-factor Dimensionality software to analyze the single and joint effects of sequence variants on prostate cancer risk. Doctoral Studies: Investigated microRNA signatures in prostate cancer to further identify the functional role of specific microRNAs in prostate cancer pathogenesis using molecular biology techniques (cloning, transformation, transfection) and in vitro assays.

University of Louisville

School of Medicine Diversity Committee Graduate Student Representative

University of Louisville

LinkedIn
2014-3 - 2016-4 · 2 yrs 2 mos

Louisville, Kentucky Area

Served as a graduate student representative in developing, implementing and aiding in recruitment diversity and inclusion efforts in the School of Medicine at the University of Louisville.

North Carolina Central University

Research Technician

North Carolina Central University

LinkedIn
2010-11 - 2011-5 · 7 mos

Durham, NC

Investigated the role of humanized orphan receptor PXR and other xenobiotic receptors in HFD induced female murine obesity and its effects on liver function and the metabolic profile (Laboratory of Dr. Emmanuel Awumey and Mentor Dr. Maxwell Gyamfi).

Education

Smith College

Smith College

LinkedIn

Biochemistry

University of Louisville

University of Louisville

LinkedIn

Pharmacology and Toxicology

University of Melbourne

University of Melbourne

LinkedIn

Biochemistry

Dominique Reed's Contact Information

Email

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Phone

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