CONFIDENTIALITY REQUESTED AND APPRECIATED

JAMES W. MORTON, PHARM.D.

Encinitas, CA

Cell: 626-***-****

ad2zdj@r.postjobfree.com

http://www.linkedin.com/in/jamesmortonpharmd

CONTRACT CLINICAL RESEARCH PROFESSIONAL

CLINICAL DEVELOPMENT ~ CLINICAL SCIENCE ~ CLINICAL STUDIES

• Senior clinical research professional with over a decade of experience in clinical operations with AbbVie, Therapeutics Incorporated and over a decade of experience in clinical development with Quest Diagnostics.

• Expertise in planning, implementation, oversight, monitoring, project management and completion of clinical studies.

• High performer skilled in developing clinical strategy, negotiating contracts and improving processes.

• Leadership of internal and external cross-functional teams ensuring adherence to scope of work, timelines and costs.

• Successful FDA approvals for three BOTOX indications; glabellar lines, hyperhidrosis and migraine headache.

• Successful clinical validations of over 50 assays, including EUA for Quest COVID-19 At-Home Rapid Antigen Test.

• Therapeutic experience in Dermatology, Neurology, Oncology, Endocrinology and Women’s Health. EMPLOYMENT BACKGROUND / TRANSFERABLE ACCOMPLISHMENTS G & P Clinical Research – San Diego, California 1/2023 – Present Contract Clinical Research Professional

• Maintain compliance with clinical study protocol and ICH guidelines for phase 1 to 3 pharmaceutical and diagnostic programs.

• Coordinate investigator site selection, training and implementation to ensure timely recruitment of study participants.

• Perform and review pre-study, baseline, ongoing and study close-out monitoring visits.

• Conduct review of electronic database (Inform/J-Review/Data Mart) submissions of concomitant medications, concomitant procedures and adverse events.

• Write study-specific documents including but not limited to protocol, informed consent, guidance document revisions (i.e. CRF completion guidelines).

• Supervised and mentor CRAs for professional development.

• Organize the trial master file in preparation for regulatory approvals. Quest Diagnostics – San Juan Capistrano, California 7/2010 – 12/2022 Director Clinical Development 1/2017 - 12/2022

• Oversaw the operations of the Quest Diagnostics Nichols Institute Clinical Development Department to support research efforts in the therapeutic areas of Genetics, Oncology, Cardiology, Immunology, Infectious Disease and Women’s Health.

• Designed, prepared and initiated clinical validation protocols for Neurology, Immunology, Oncology and Women’s Health Laboratory Developed Tests. Implemented the design, initiation, execution, close-out and final results for 8-12 projects a year.

• Clinical Lead for collaborative clinical studies between Quest Diagnostics and Key Opinion Leaders that expanded the utility of Quest Diagnostics existing testing. 5 projects initiated annually.

• Headed protocol development, contract execution, IRB approvals, budget and study operational guidelines. JAMES W. MORTON Page Two

EMPLOYMENT BACKGROUND / TRANSFERABLE ACCOMPLISHMENTS (Continued)

• Advised stakeholders in a cross-functional matrix environment which includes Medical Affairs, Laboratory Operations, Biostatistics, Regulatory, Data Management and Clinical Development to execute initiatives that develop clinically relevant research that supports the business needs for our new and existing Laboratory Developed Tests.

• Business manager for the bi-weekly Senior Management review and prioritize 30 clinical project submissions per year from Clinical Franchise Units (Oncology, Immunology, Neurology, Cardiology/Metabolism, Infectious Disease, and Women’s Health).

• Reviewed study data and materials for development of abstracts, publications and scientific meetings. Senior Clinical Programs Manager 7/2010 -12/2016

• Evaluated the needs and implemented effective management of a pivotal study that investigated a novel diagnostic’s ability to detect pregnancy significantly earlier than the current standard of care.

• Improved existing research specimen collection protocols and established two new collection protocols that significantly increased access to prismatic sample types.

• Prepared guidelines for the Clinical Development Department to address the pending FDA oversight of Laboratory Developed Tests.

Independent Clinical Research Consultant – San Diego, California 2/2008 – 5/2010 Under contract with Integrium, LLC 2/2010 -5/2010

Project Leader

• Supported business development of a dermatology clinical research group within the company’s existing cardiovascular and metabolic disease research groups.

• Initiated relationships with dermatology Key Opinion Leaders in the United States. Served as team leader for execution of client directed drug development goals. Under contract with Amgen, Inc 2/2009 -1/2010

Medical Information Specialist

• Educated health care professionals on emerging trends in oncology.

• Replied to complex written and verbal inquiries from Health Care Providers, Regional Medical Liaisons and Pharmaceutical Sales Representatives pertaining to Amgen’s line of oncology products.

• Authored serious adverse event reports, scientific analyses and medical information letters. Under contract with ISTA Pharmaceuticals, Inc 9/2008 -1/2009 Clinical Research Manager

• Coordinated deliverables from all departments to secure an on time NDA submission for the companies’ lead ophthalmology agent to the FDA.

Under contract with Allergan, Inc 2/2008 - 9/2008

Clinical Study Manager

• Developed and implemented a close-out strategy for the BOTOX management team’s pivotal PREMMPT I and PREMMPT 2 studies that addressed anticipated obstacles. The team met milestones for patient retention, database lock and investigator site closeout.

JAMES W. MORTON Page Three

EMPLOYMENT BACKGROUND / TRANSFERABLE ACCOMPLISHMENTS (Continued) Therapeutics Inc. – San Diego, California 3/2005 – 2/2008 Clinical Projects Manager

• Supervised a staff of clinical research associates that conducted qualification, initiation, follow-up, and close-out site visits to ensure adherence to clinical protocol. This team successfully started and ended 4 phase 2/3 clinical studies under my direction.

• Conducted site qualification, investigator training, routine and study close-out monitoring visits.

• Responsible for design, management and execution of Investigator Meetings.

• Maintained TMF files for successful FDA submission. Independent Clinical Research Consultant – Pasadena, California 2/2001 – 3/2005

• Led investigational drug monitoring and randomization activities for the reformulation of BOTOX.

• Center for Drug Evaluation and Research, Division of Dermatology was evaluating a new therapeutic measure of bioequivalence testing in analgesic drug products. Worked with the Clinical Pharmacology and Biopharmaceutics Department to develop a comparator that is more effective than AUC, Cmax and Tmax.

• Reviewed pre-clinical regulatory packets and supported the CDER, Clinical Pharmacy and Biopharmaceutics recommendations for how sponsors should proceed along the regulatory pathway toward approval. Allergan - Irvine, California 8/1996- 2/2001

Clinical Research Associate 2/1998 - 2/2001

• Managed day-to-day operations of BOTOX Phase 2/3 clinical trials verifying the highest quality data and International Conference on Harmonization /Good Clinical Practice compliance.

• Performed enrollment, monitoring and study close-out activities for the phase 3 clinical research trial for BOTOX treatment of glabellar lines and the phase 2 clinical trial for BOTOX to treat hyperhidrosis.

• Conducted site initiation, routine and study close-out monitoring visits.

• Maintained TMF files for successful FDA submission.

• Reviewed and approved site initiation, routine and study close-monitoring reports submitted by regionally based CRAs.

• Reviewed Concomitant Medication, Procedures and Serious Adverse Event CRF in advance of database lock.

• Lead the planning and execution of Investigator/Study Kick-off meetings. Associate Research Scientist 9/1996 - 2/1998

• Synthesized compounds for biological evaluation in the areas of ophthalmology and dermatology for IND submission.

EDUCATION

Pharm.D, University of Southern California, Los Angeles, California BA, Chemistry, Occidental College, Los Angeles, California

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