Rex L. Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Stamford, Connecticut, US

• Led a team of direct reports responsible for clinical pharmacology, DMPK (post-IND), pharmacometrics, bioanalytical methods, Phase 1 clinical operations, medical and regulatory writing, and subject matter support for.
• Held primary responsibility and oversight for vendors, software, and personnel supporting the pharmacology function, including long-range planning, budgetary forecast and reconciliation, project scope negotiation, and.
• Responsible for nonclinical and clinical pharmacology development and regulatory activities supporting the FDA approval and MAA submission of Ogsiveo for Desmoid Tumors and NDA and MAA submissions of Mirdametinib for.
• Oversaw nonclinical and clinical pharmacology contributions for NDAs, MAAs, INDs, and regulatory strategy under FDA, EMA, and PMDA.
• Provided dose selection and study design recommendations and led the execution of Phase 1 pharmacokinetic studies.
• Developed standard processes and working infrastructure for a growing pharmacology department.

Stamford, Connecticut, US

Stamford, Connecticut, US

Laval, Quebec, CA

• Supported 6 distinct development programs as the clinical pharmacology subject matter expert on global clinical trial teams in gastrointestinal, dermatological, and neurological therapeutic areas.
• Designed dose-ranging studies to support repurposing of existing assets for treatment of patients with Sickle Cell Disease and for COVID-19.
• Collaborated with cross-functional program teams to provide responses to urgent information requests from FDA, Health Canada, and various competent authorities under EMA.
• Conducted preliminary analyses and simulations for internal decision making.

Research Triangle Park, NC, US

• Held direct responsibility for resources and timelines for over 50 clinical pharmacology projects with more than 25 different clients, ranging from preclinical assets through post-marketing commitments and spanning.
• Supported the development of YUTREPIA for Pulmonary Arterial Hypertension, from IND to NDA, under Liquidia Technology’s 505(b)(2) development program as a client-embedded clinical development scientist and pharmacology.
• Interacted with KOLs and senior leadership teams to facilitate and plan the strategic development of client programs.
• Served as a clinical study lead for more than 8 clinical pharmacology studies including ascending dose, relative bioavailability, drug interaction, food effect, and patient dose-range finding studies for oral and.
• Conducted NCAs and simulation studies and authored analysis plans, PK reports, clinical study protocols, and eCTD summaries for nonclinical and clinical pharmacology.

Research Triangle Park, NC, US

• Provided leadership and training for a team of up to 12 direct reports as the primary manager of the Project Management Division.
• Implemented a company-wide project portfolio and work management tracking system resulting in streamlined monitoring of resource allocation and significantly improved project scheduling capabilities.
• Participated in the proposals and invoicing process for client projects and held approval authority for change orders to existing contracts.
• Analyzed cost and performance data to refine company methods for risk-adjusted cost estimation and market-supported price determination.
• Facilitated the buildout, implementation, and growth of regulatory electronic submissions and publishing services.
• Managed early-stage clinical development and regulatory activities for two clients ranging from in vitro nonclinical study coordination through IND development and into Phase 1 clinical studies.

Research Triangle Park, NC, US

Research Triangle Park, NC, US

Research Triangle Park, NC, US

Research Triangle Park, NC, US

Research Triangle Park, NC, US

Chapel Hill, NC, US

• Research Associate under Dr. Terry Magnuson (August 2010 – February 2014)
• Investigated the involvement of epigenetic regulation and chromatin organization in the maintenance of allele-specific gene expression bias
• Optimized conditions to perform chromosome conformation assays (3C, 4C, and Hi-C) in trophoblast stem cells.
• Wrote novel software, using Perl and R, and to identify correlations in ChIP-Seq, RNA-Seq, and 4C-Seq datasets
• Used bash scripts to build 4C-seq analysis pipelines for automating read processing, Bowtie alignment, analysis with the fourSig statistical package, and generation of data visualizationsResearch Associate under Dr..
• Studied the role of SOX2 transcription factor in regulating neural stem cell identity in the developing mouse retina

Chapel Hill, NC, US

• Implemented an operations strategy for performing reverse genetic mutagenesis screens as a service to investigators
• Employed capillary electrophoresis and HPLC-based SNP detection technologies to detect positive hits
• Used the peptide-sequence alignment and prediction algorithms to prioritize lead-candidate mutations
• Interacted with customers to determine expectations and interests

Cold Spring Harbor, New York, US

• Managed and prepared reagents and equipment for laboratory practicals
• Assisted instructors with technique demonstrations
• Trained students to perform laboratory techniques in mouse embryology and cell culture

Houston, Texas, US

• Generated sequencing libraries and performed quality control experiments in preparation for Sanger sequencing
• Prepared weekly reports to track progress of DNA fragments in the sequencing pipeline
• Managed a team of 5 technicians in the bacterial transformation core

Ph.D., Genetics & Molecular Biology

Bs, Biochemistry