Norton Clinical Development Consulting (Oct 2018 - present)

(Independent consulting in all areas of drug development)

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2018-present: President, NCDC, Preston, ID

Provide strategic support to start-ups/small/emerging pharmaceutical and biotechnology companies in all areas of drug development. Consult for VC and investments groups on various areas within drug development including CROs; COVID-19 impact (current and future); strengths, weaknesses and opportunities in the industry; etc.

 

Elevar Therapeutics (Feb 2019 - Dec 2020)
(Small, private, clinical-stage oncology drug development company; formerly LSK BioPharma)

2020: Chief Drug Development Officer, Elevar Therapeutics, Salt Lake City, UT
Responsible for all aspects of drug development for two oncology products. Member of the
executive leadership team. Close collaboration with the CEO, CFO, head of drug manufacturing
and the Chief Commercial Officer to ensure support and alignments of activities. Direct
activities of multiple departments within the Drug Development Division including non-clinical
development, DMPK/clinical pharmacology, clinical operations, medical/scientific affairs,
program management, biometrics, medical writing, regulatory affairs and drug safety and
pharmacovigilance. Responsible development of budgets and approval of expenses. Direct
management and administrative aspects of the Division, including recruiting and training;
coaching and discipline and performance reviews. Implement systems, policies and standard
operating procedures.

2019-2020: Global Vice President Clinical Development, Elevar Therapeutics, Salt Lake City, UT
Responsible for strategic development of company compounds working with internal and
external KOLs, medical and scientific committees/boards. Develop target product profiles and
integrated drug development plans and drive protocol development in support of these plans.
Lead multiple departments including g Clinical Pharmacology, Clinical Operations, Medical
Affairs, Biometrics, Clinical Development & Scientific Affairs (including medical writing, medical
monitoring and clinical science) and Drug Safety and Pharmacovigilance. Work with Commercial
Development on publication plans, medical information and scientific services, medical and
scientific intelligence and medical science liaisons.

Covance Inc (Dec 2005 – Oct 2018)
In my various roles at Covance, one of my primary responsibilities was working effectively with
internal and external cross-functional teams to create early development strategies. This
included generating project and program development strategies with the goal of maximizing
the chances of delivering on the objectives on time and within budget. I was also responsible for
ongoing tracking and maintenance of programs to ensure deliverables, as well as ensuring that
internal and external leadership expectations were being met.

2016 - 2018: Executive Director, Medical & Scientific Affairs, Clinical Pharmacology Services,
Covance Inc.
Provide strategic, global scientific/clinical/regulatory support for global clients and global
Covance Early Clinical Development project teams. Identify and implement scientific and clinical
strategies in support of global client projects and clinical opportunities. Responsible for the
management, administration and organization of the global ECS Medical & Scientific Affairs
scientific team.

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2008 – 2016: Scientific Program Director, Early Clinical Development, Clinical Pharmacology,
Covance Research Unit Inc.
Direct the organization, management and administration of the Medical & Scientific Affairs
group within Early Clinical Services. Responsible for providing medical monitoring, safety and
pharmacovigilance services to assigned projects and ensuring adequate medical coverage for all
projects 24/7/365. Developed processes for managing safety of subjects enrolled in Phase I-IIa
clinical studies and SAE reporting procedures in compliance with company SOPs, global
regulations and standard industry practices. Created and implemented a training curriculum for
medical monitoring early clinical studies. Grew the business 200% over a period of 3 years.
Participated in the initial clinical feasibility assessment of client requests for proposal (RFP) and
responsible for supporting the preparation and defense of Early Clinical Development (ECD)
proposals. ECD is focused on managing Phase Ib/IIa, single or multi-site, proof-of-concept
clinical studies in patient populations. Provided training and strategic planning support to ECD
project teams.

2005 - 2008: Associate Director, Early Clinical Development, Clinical Pharmacology, Covance
Clinical Research Unit Inc.
Responsible for the management, administration, and organization of the ECD business unit
including the profit and loss performance of the department and driving revenue growth by
developing a strategic business plan and aggressively supporting the sales and marketing of the
unit. Fully involved in preparing and defending proposals. Over a period of 2½ years grew the
business from 5 full-time employees to about 34 employees (29 full-time and 5 contractors),
which included establishing a management/organizational infrastructure and training program.
Over this same period grew ECD revenues 500% with very favorable operating margins.

 

Wyeth Research (Feb 2004 – Dec 2005)

2004 - 2005: Associate Director, Clinical Trial Operations, Wyeth Research, Cambridge,
Massachusetts
Managed multiple, global, cross-functional project teams responsible for conducting Phase I-III
clinical trials in oncology. Responsible for the site selection and initiation process. Directed site
budget negotiations and investigator contracting decisions. Tracked patient enrollment, site
monitoring, and closeout activities and implemented changes as needed to meet study
objectives. Directed trial progress through the startup, ongoing study execution, and site
closeout. Managed all study communications including internal, external, central labs, vendors,
and CROs. Directed clinical pharmacy and data management activities, maintained the trial
execution plans and time lines, and managed study budgets of more than $50 million.

 

 

Atrix Laboratories (Apr 2002 – Feb 2004)
(Small, public, drug delivery company; focused on oncology and dermatology; acquired by QLT)
 

2003 - 2004: Director, Clinical Research, Atrix Laboratories, Fort Collins, Colorado
Participated in senior executive-level strategy and planning meetings. Responsible for
organizing and managing clinical trial activities, including: study site identification; coordinating
clinical supplies; writing, reviewing and editing investigator brochures, clinical protocols, ICFs,
and CRFs; hiring, training and scheduling CRAs; and maintaining central files. Managed clinical
data management, programming, biostatistics, medical writing, and safety. Developed and
managed clinical research budgets; negotiated and managed clinical contracts between PIs,
consultants, CROs and central labs. Supported regulatory affairs in the preparation of INDs,
NDAs and other regulatory documents.

2002 - 2003: Associate Director, Clinical Development, Atrix Laboratories, Fort Collins,
Colorado
Wrote clinical study protocols (Phases I-IV). Planned and interpreted clinical trials; established
scientific methods for study design. Prepared and reviewed investigator brochures, study
reports, and clinical sections of FDA submissions (e.g., INDs, meeting packages, and NDAs).
Acted as a liaison with other companies working with Atrix under licensing agreements and
joint ventures; evaluated in-licensing opportunities for various compounds.
2002: Associate Director, Project Management, Atrix Laboratories, Fort Collins, Colorado
Organized and directed all aspects of multiple drug development projects. Designed,
implemented and monitored product development plans; established scopes of work for
projects; and directed both internal and external project activities across multiple functional
areas.

 

IOMED (Aug 2000 – Apr 2002)
(Small, public, medical device company; focused on inflammation)

2001 - 2002: Product Manager, IOMED, Inc., Salt Lake City, Utah
Participated in senior sales and marketing management meetings. Organized marketing
activities for the company's 510(k)-approved medical devices. Responsible for the development
and placement of new advertising materials; managed changes in product labeling. Organized
trade show activities and staffed trade show booth.

2000 - 2001: Clinical Program Manager, IOMED, Inc., Salt Lake City, Utah
Participated in senior executive-level strategy meetings. Managed pre-clinical, clinical,
regulatory, and market research activities for major company development projects.
Maintained project timelines and managed project budgets. Wrote protocols, monitored for
cGCP compliance, and prepared final reports for Phase I clinical studies. Helped write and
review multiple NDA sections.

 

Pharmadigm (Oct 1993 – Aug 2000)
(Small, private, startup pharmaceutical company; focused on immunology)

1999 - 2000: Manager, Non-Clinical Development, Pharmadigm, Inc., Salt Lake City, Utah
Participated in compound development strategy meetings with senior management. Designed,
implemented, and monitored nonclinical studies conducted at CROs; coordinated internal and
external study activities (including GMP drug manufacturing, packaging, and shipment);
established scope of projects, evaluated study proposals; managed contracts with external
CROs; and developed and managed project budgets. Helped write sections of multiple INDs.

1995 - 1999: Study Director, PK, Pharmadigm, Inc., Salt Lake City, Utah
Wrote numerous SOPs, scheduled projects, and prepared and managed budgets and outside
vendors for non-clinical projects including rat and dog toxicology studies, cytochrome P450
assays, mutagenicity, etc. Validated GLP assays, managed assay of samples per cGLP
regulations, troubleshot problems, hired and trained personnel, and prepared final reports.

1993 - 1995: Senior Scientist, Pharmadigm, Inc., Salt Lake City, Utah
Organized and conducted research characterizing the anti-inflammatory properties of the
company’s lead compounds. Developed strategies for solving complex research problems,
collaborated with outside experts, wrote protocols and scientific reports related to compounds
anti-inflammatory properties. Managed and trained personnel and set-up and managed
laboratory facilities.