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
United States
Durham
Biotechnology
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

Nonclinical Medical Writer
Self Employed
Durham, North Carolina, United States

Senior Regulatory Writer, Gene Therapy Program
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).

Nonclinical Scientist, Nonclinical Safety
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.

Postdoctoral Research Fellow, SKAGGS School of Pharmacy
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.

President
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.

Co-Vice President
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.

Co-Chair of PDA Seminar Series
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.

Young Scientist Committee Representative
-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.

Mentoring and Career Development Committee Graduate Student Representative
-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.

Doctoral Fellow
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.

School of Medicine Diversity Committee Graduate Student Representative
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.

Research Technician
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).
Dominique Reed's Contact Information
Phone
Find the Right Leads
Find Verified Contact Data
What LeadContact does well
Find verified emails, phone numbers, and decision-makers with 98% accuracy.
Find Leads
Find the right people by company, role, industry, location, and more.
925M+ professional profiles

Find Emails
Access verified email addresses for your target contacts.
657M+ emails

Find Phone Numbers
Get cross-validated phone data from multiple top sources.
239M+ phone numbers

More Accurate. Lower Cost.
Find contact data in 1 tool with 98% accuracy
LeadContact integrates leading enrichment tools to deliver more accurate contact data—without paying for each one.
Great conversations start with the right contact.
It’s time to find yours.





