Terri Morton

Looking for a part-time position

Experienced Clinical Pharmacologist

Serve as a Clinical Pharmacology expert to the industry.

• Performed duties as clinical pharmacology lead on Phase 2 and Phase 1 projects and project teams helping to take compounds from in vitro to in vivo in humans and submissions to regulatory authorities. • Advised core and clinical teams on drug discovery projects, as lead pharmacologist. • Researched compounds to clinical studies • Performed PK analysis and simulations for projects. • Contributed as primary author on two manuscripts. • Wrote clinical pharmacology portions of CTIS submission to the EU, study protocols and other documents.

• Served primarily as clinical pharmacologist and pharmacokineticist and expert to research as related to drug development process. Planned and directed pharmacokinetic components of clinical programs. • Oversaw pharmacokinetic and pharmacology input to project development teams acting as core team leader for clinical development. • Developed clinical pharmacokinetic study designs, perform pharmacokinetic analysesd, summarized, interpreted and presented data to project teams. • Wrote clinical product profiles (CPPs), pharmacokinetic portions of protocols, clinical study reports, and eCTD/IND/NDA submissions frequently. • Provided modeling and simulation data to innovations team, helping to advance pipeline of long-acting injectables. • Used pharmacokinetic modeling software such as Phoenix WinNonlin for PK modeling and for in vitro-in vivo correlations and Phoenix NLME for population pharmacokinetics. • Oversaw bioanalytical testing of clinical and nonclinical samples to ensure valid methods available and performed according to regulatory body standards (EMEA, FDA, ANVISA). • Planned for and helped budget Phase 1 – 3 studies and other clinical research.

• Acted as clinical technical lead on numerous Phase 1 studies, including bioavailability, human abuse potential, and pediatric studies (PREA) to support FDA commitments. • Provided oversight of all aspects of clinical trials, as well as helped to develop target product profiles and clinical development plans. • Involved with projects teams in all aspects of drug development. • Took lead frequently in interfacing with outside pharmacokinetic, pharmacology, and toxicology experts. • Authored clinical protocols, INDs NDAs and other documents

Retained previous responsibilities, and provided pharmacokinetic expertise to clinical scientists regarding IND and NDA filings and development and implementation of pharmacokinetic studies, CRO selection, budgeting and oversight, and bioanalytical lab activities. Provided pharmacokinetic and pharmacology input to project development teams for new generic and branded products. Offered pharmacokinetic expertise in writing clinical development plans for R&D projects. Oversaw writing of clinical pharmacokinetic and preclinical sections of INDs, NDAs, and pharmacokinetic portions of ANDA submissions. Delivered pharmacokinetic expertise in responding to and interfacing with FDA.

Provided PK/DM input to other research and development staff on drugs developed for ANDA submissions. Developed and wrote study protocols and clinical reports Worked on project teams as pharmacokinetics expert with formulators, analytical chemists, regulatory affairs, and upper management. Provided technical expertise to research and development staff in areas of clinical and preclinical pharmacokinetics, including PK consults for formulation development staff. Researched, wrote and defended portions of NDA submissions relating to clinical and nonclinical pharmacokinetics and drug metabolism to Food and Drug Administration for several classes of drug products, which included beta-blocker with nitric oxide release activity (nebivolol) and drug to treat off symptoms in patients with Parkinson’s Disease.

Teaching assistant for basic and advance pharmacokinetics classes for PharmD students.