Management Project
Resume:
Jayden Montgomery, PhD
**** ****** **** **. *** Ridge, NC 27310 336-***-**** ab8vly@r.postjobfree.com
DIRECTOR CLINICAL RESEARCH DIRECTOR PROGRAM MANAGEMENT
DIRECTOR PORTFOLIO MANAGEMENT
Multi talented, high performing PMC certified professional with over 11 years of industry experience
leading cross functional, multidisciplinary drug development teams to deliver new small molecule therapies
from discovery through registration and launch. Supervised all phases of product development for multiple
therapeutic pharmaceutical projects; highly experienced in clinical strategy development. Skilled in
stakeholder management and coordinating project deliverables. Knowledge of GCPs, ICH and FDA
regulations. Focused on strategic planning and risk mitigation, while managing operational progress and
managing competing demands. Seeking multi faceted role in a biotech/biopharmaceutical company where I
can have a significant impact.
Expertise includes
Program Management Timeline Management Strategic Planning
1. 5.
2. Program Development 6. Project Scope Problem Solving
3. Team Leadership Development Vendor Management
4. Teamwork 7. Budget Management Multi Project
8. Alliance Management Operations
Therapeutic Project Experience
Analgesics (Pain) Anti-Inflammatory (Rheumatoid Arthritis)
Metabolism and Endocrinology (Obesity, Type II Diabetes) Respiratory
diseases (Asthma) Psychiatry (Major Depressive Disorder)
Neurology/Neuropharmacology (Attention Deficit Hyperactivity Disorder;
Parkinson’s disease; Schizophrenia) Smoking cessation Overactive
Bladder
Professional Experience
TARGACEPT, INC. – Winston Salem, NC 27101 2008 Present
Jayden Montgomery, PhD
SENIOR PROJECT DIRECTOR
1. Functional head of project and portfolio management at Targacept.
2. Drive fully integrated cross function (CMC, Clinical, Preclinical, DMPK, and Toxicology) teams
from predevelopment to closure, or partnering at a clinical stage biotech company where
stakeholder management and risk management are key and funding is continually reprioritized.
3. Responsible for project strategy development, design, implementation, execution, and submission of
Targacept portfolio and clinical programs.
4. Define strategic and operation plans to align with corporate goals; created the company’s first
strategic development plans, and risk identification/contingency option processes.
5. Coordinate outsourcing work for projects from definition of work and vendor selection through
execution and close out. Vendor management is key as Targacept functions virtually.
6. Interface with Key Opinion Leaders and created Advisory Board to formulate development strategy,
protocols, and submissions for indications Targacept had no previous experience (asthma/type II
diabetes).
7. Coordinated writing activities and write IND submissions including annual reports, briefing
documents, clinical protocols, clinical protocol amendments, and study reports.
Review clinical study protocols, data tables, and study reports that support the clinical programs.
8.
Coordinate project management/portfolio SOPs, and review and help develop clinical SOPs.
9.
Accomplishments:
Managed timeline, budget, created phase III budget and program, and helped in partnering activities
1.
of TC 5214, in which AstraZeneca paid Targacept a $200 MM upfront payment.
Developed and launched new project management processes for cross functional teams within a
2.
biotech/biopharmaceutical company that previously did not have a project management function.
1. Defined a portfolio stage gate decision structure with standardized criteria.
2. Established tools for tracking program progress against objectives and key performance
indicators, setting the standards for all projects. Established tools for estimating resource needs
for the entire company portfolio.
3. Developed a formal risk management tool and system.
4. Created first development budgetary and FTE templates for a small biotech/biopharmaceutical
company.
5. Created and launched project management tools to effectively present project progress, and
decisions to Senior Management and governance bodies as well as for use by project team.
Helped CEO create company Portfolio Management Committee that serves as the portfolio
1.
governance review board resulting in increased input and improved decision making.
o Coordinated creation of agendas with senior management and therapeutic area leads.
o Served on committee and acted as scribe, in charge of writing and posting meeting minutes.
o Managed committee action items for senior management.
8403 Creeks Edge Ct. Oak Ridge, NC 27310 336-***-**** ab8vly@r.postjobfree.com
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Jayden Montgomery, PhD
Helped management team revamp company preclinical governance committee, resulting in meeting
and decision making efficiencies.
o Served on/contributed to committee and coordinate communication between discovery and
development teams and governance committees.
SCHERING PLOUGH (formerly ORGANON BIOSCIENCES and INTERVET) – Millsboro, DE 19966
(decided to leave organization after Schering Plough buyout and announcement that Delaware site to be
closed summer 2009) 2001 – 2008
SENIOR PROJECT LEADER – PHARMACEUTICALS (Jul 2006 – Sep 2008)
10. Spearheaded designing, implementing and monitoring development plans and budgets, providing
thorough, accurate and timely reports, and fulfilling the duties and responsibilities as required
company project management system.
11. Trained new project leaders and administrative duties within project group.
12. Responsible for organizing and conducting meetings (team, FDA, and collaborative departments).
13. Managed multiple studies, pre clinical, clinical and other good laboratory practice studies
conducted as part of local and/or global product development. Was responsible for writing
protocols and study reports, and management of project deliverables. Functioned as sponsor
representative or study monitor for multiple studies and different projects.
14. Served on Zilpaterol launch team coordinating planning and logistics between R & D, clinical,
commercial, marketing and manufacturing. Managed development and launch of Phase 4/life cycle
management work for Zilpaterol.
Accomplishments:
Managed global development of zilpaterol including multiple approvals in North America
(including FDA approval) and launched the product in multiple countries in North America/Central
America. Helped develop and execute post market clinical strategy and lifecycle management plans
and was an instrumental launch team member. Zilpaterol is now the number one top selling product
for the animal health division of the company.
GLOBAL PROJECT LEADER – PHARMACEUTICALS (Jan 2003 – Jul 2006)
15. Led global cross functional multidisciplinary drug development teams across all phases of product
development for multiple projects.
16. Served as study monitor/sponsor representative for multiple studies and managed contract monitors.
17. Led protocol and study design, contingency planning and contributed to resolving conflicts.
18. Cooperated with companies to develop alliances/strategies for obtaining new drug approvals.
CLINICAL RESEARCH SPECIALIST – PHARMACEUTICALS (May 2001 – Jan 2003)
8403 Creeks Edge Ct. Oak Ridge, NC 27310 336-***-**** ab8vly@r.postjobfree.com
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Jayden Montgomery, PhD
19. Served as lead CRA/study monitor for pivotal Phase III clinical package.
20. Organized initiation, conduct, reporting, and monitoring of multiple studies being conducted
simultaneously. Was responsible for providing protocol specific training and reporting of studies.
Managed Project Leading to FDA Approval (New Animal Drug Applications;
NADA)
Zilmax® (Zilpaterol hydrochloride) NADA 141 258. Approved 10 Aug 2006.
2.
3. Additional Life Cycle Management NADA approvals (NADA 141 276, Approved 10 Jan 2008;
NADA 141 278, Approved 15 Feb 2008; NADA 141 282, Approved 22 Feb 2008; NADA 141 280,
Approved 29 Feb 2008; NADA 141 284, Approved 29 Feb 2008).
Education
TEXAS TECH UNIVERSITY – Lubbock, TX Doctor of Philosophy, 2001
IOWA STATE UNIVERSITY – Ames, IA Master of Science, 1997
TEXAS TECH UNIVERSITY – Lubbock, TX Bachelor of Science, 1994
COLLEGE OF THE SEQUOIAS – Visalia, CA Associate of Science, 1992
Certifications & Training
PMP® PROJECT MANAGEMENT PROFESSIONAL CREDENTIAL HOLDER
Trained in GCPs, GLPs, cGMPs, ICH & FDA guidelines
Recent Presentation
“Managing R & D Projects at a Small Biotech”. Project & Portfolio Management for the Drug & Device
Industry, 21 Sep 2011.
Professional Associations
Drug Information Association Texas Tech University Alumni Association
4. 7.
5. Project Management Institute 8.
6. Iowa State University Alumni Association
8403 Creeks Edge Ct. Oak Ridge, NC 27310 336-***-**** ab8vly@r.postjobfree.com
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Jayden Montgomery, PhD
References
Available upon request
8403 Creeks Edge Ct. Oak Ridge, NC 27310 336-***-**** ab8vly@r.postjobfree.com
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