R&D Strategic Leadership Complex Global Program Cross-Functional Teams
Resume:
Dennis Carson, PhD, DABT
C: 682-***-**** ? ************@*****.***
HTTP://WEBPROFILE.INFO/DCARSON/
SR. DIRECTOR R&D PROGRAMS
Senior R&D leader with proven experience in bio/pharmaceuticals and medical
devices bridging technologies to business imperatives, and leveraging
technologies to the advantage of enterprise. Leverage high-level success in
directing large-scale strategic programs, including overseeing full R&D
lifecycle.
Core Competencies
R&D Strategic Leadership Complex Global Program Cross-Functional
Management Leadership
RFP Development / Resource Identification & Vendor Analysis /
Optimization Allocation Negotiations
Situation Analysis / Strategic Product Planning / Budgeting / Planning /
Solutions Dev. Execution Cost Control
Experiences in
GLP/GCP/GMP
Preclinical Project Management Medical Science Liaison
Clinical Regulatory Submissions
CMC Scientific Writing
Marketing/Sales
Professional Experience
SMITH AND NEPHEW BIOTHERAPEUTICS - Fort Worth, TX 2008 - March 2014
Sr. Director Strategic Program Leader (2011 - 2014)
400-member biopharmaceutical company concentrated in chronic wound field
with two BLA products and cell therapy in Phase 3 trials. Strategic Program
Leader responsible for overall development of cellular therapeutic, as well
as ensuring overall program success. Ensure strategic objectives for
program are clearly defined and effectively managed.
. 47% reduction in unnecessary meeting time achieved by providing more
efficient allocation of labor costs and by reorganizing project team
structure.
. Addressed 100% of communication barriers by taking initiative to provide
on-site relationship and cultural bridge building with Swiss operation.
. $1 million in projected daily future product revenue protected by meeting
on-time project delivery through outsourcing validation and method
development at minimal marginal cost increases.
Sr. Director Research & Development (2008 - 2011)
Held responsibility for overall progress, completion and content of
company's R&D projects, including leading departmental team of 17 reports.
Oversaw resource planning, management and budgeting for department,
ensuring resources and projects are aligned with larger strategic corporate
objectives.
. 100% revenue increase supported by clearly demonstrating need to expand
young R&D department from eight to 17 FTE in four years.
. Dramatically improved product sales by providing sales team with key
product information based upon in-depth analysis of potential inhibitors
to product success.
. Saved company from paying $200,000 in unapproved contract work by
instituting procedure that ensured no work was performed without proper
authorization.
. Increased company's brand value through training and directing effective
research effort that produced five presentations and publications
annually.
. Virtually eliminated obstacles to program delivery timelines by
evaluating and replacing key leadership position within R&D group.
ALCON LABORATORIES - Fort Worth, TX 1990 - 2008
Sr. Manager Clinical Market Support (2004 - 2008)
Multi-billion dollar, global ophthalmic pharmaceutical company developing
and marketing pharmaceuticals, medical devices and medical instruments.
Oversaw all activities to clinically support current marketed surgical
products; including planning, coordinating and conducting in vitro, bench,
animal and human studies.
. $1 billion in product value generated over five years by acting as
liaison between R&D and marketing, applying technical expertise to
provide scientific validation to five marketing campaigns.
. Enhanced sales team's understanding of complex technical information,
helping team to gain competitive advantage for products in marketplace.
. 21% increase in overall product acceptance achieved through design and
execution of unique phase 4 clinical study, allowing Marketing to address
significant competitive threat.
. $500 million in product potential protected through collaborative
development of manuscript that demonstrated 30% improvement in company's
product over existing competitive products.
. Improved company's ability to communicate product understanding to
customer base as a result of developing previously unavailable pictures
demonstrating advantages.
Assistant Director R&D Clinical (2001 - 2005)
Directly accountable for conducting phase 4 studies to support marketed
products, holding responsibility for addressing product complaints with R&D
and clinical studies. Additionally, served as clinical representative on
early development teams while leading team of two direct reports.
. Successfully ensured numerous multi-million dollar clinical studies were
completed without interruption as a result of resource allocation shifts
that covered departure of employee from another group.
. Validated thousands of dollars spent on sending employees to key meetings
by effectively capturing information from outside meetings.
Principal Scientist (1990 - 2001)
Led one supervisor as direct report and 12 technicians as indirect reports,
overseeing all toxicology aspects of assigned Ophthalmology projects. Wrote
technical reports, product releases, and toxicology sections of INDs, NDAs,
Annual Reports, Investigator Brochures and other U.S. and International
Submissions.
. Led successful turnaround of underperforming employee through coaching;
saving company thousands of unnecessary dollars in hiring and training
process.
. Led low-priority project to endpoint, allowing team members to spend 10%
of time on higher priority projects.
. Gained high-level expertise in all ocular evaluation methods utilized in-
house, becoming only in-house resource that could perform all study
types.
Education / Certification
PhD, Environmental Health (Toxicology), University of Cincinnati Medical
School
BS, Chemistry, University of Oklahoma
Diplomate of the American Board of Toxicology
Certified Biotechnology Manager, European Compliance Academy
cGLP, cGCP, cGMP Regulatory Compliance Training
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