As a Business Development Manager in the dynamic field of early-stage clinical research, my mission extends beyond merely fulfilling resource requirements. Understanding the intricacies of each client's needs allows for the development of tailored solutions that fill immediate roles and support long-term strategic goals. We emphasize collaboration and transparency, fostering an environment where innovative ideas thrive. Our approach is adaptable, constantly evolving with the scientific landscape to ensure we deliver impactful and relevant support. By leveraging Actalent's expansive network and industry expertise, we are well-equipped to tackle challenges head-on, providing our clients with the confidence and resources necessary to move their research forward effectively. Together, we can drive meaningful progress in clinical trials, ultimately contributing to advancements in global healthcare.

Certara, the global leader in translational medicine since 2014. Our customers have received 90% of new drug approvals by the FDA in the past nine years, along with over 300 global regulatory and health authority submissions prepared in the last five years, which is an impressive record both in terms of volume and expertise. With my extensive experience in the biotech and healthcare sectors and a proven track record of driving significant revenue growth, I am well-positioned to help this innovative company expand its influence and market reach. By leveraging my strong network of healthcare stakeholders and comprehensive understanding of the drug development process, I aim to spearhead initiatives that advance the organization's objectives and contribute to the broader goals of healthcare innovation and patient care. My passion for combining cutting-edge technology with strategic market expansion initiatives will be instrumental in navigating the complexities of the global healthcare landscape and ensuring our collective success."

ChemDiv is a global innovator and leader in accelerated discovery and development. ChemDiv designs execution-ready integrated discovery/development projects that enrich partners’ pipelines with best-in-class molecules on accelerated timetables and full accountability for interim and project milestones.

RxE2 is the first company to make Decentralized Clinical Trials a cost-effective reality by integrating pharmacy practice into every aspect of clinical trials. RxE2 empowers local pharmacists, as trusted medication experts, to utilize their extensive patient knowledge to make clinical trials more accessible for Everyone, Everywhere, to vastly reduce clinical trial timelines and costs, and help study sponsors and patients achieve higher quality outcomes with diversity-focused recruitment and clinical drug dispensing.• Hired, developed, trained, and coached team to execute and monitor all lead generation strategies aligned with aggressive development goals for clinical lab and dispensing services • Managed all hunting/lead generation activities for new business including sales calls, proposal development, negotiations, marketing, social media campaigns • Developed and facilitated training of lead generation software for the teams• Designed marketing plan for multi-platform service offerings• Researched client product portfolios, strategies and monitored competitive developments, sponsor insights, and regulatory landscapes to influence planning, positioning, and B2B product/service pricing • Strengthened client relationships with new and existing accounts • Headed virtual investigator meetings with prospects to educate them regarding on-site development, clinical study practices, and clinical staff development • Integrated account management frameworks and performance management tools to guide innovation, new product development, and bring new products to market

Cytel is the world’s largest biometrics organization focused on delivering advanced analytical solutions and are thought leaders in innovative trial designs specializing in strategic consulting (adaptive/complex study designs), functional service provider (FSP), phase I-IV study biometrics execution, study based support and software.• Directed team of 5 to oversee PNW territory, customer base, market clinical trial design, competitive landscapes, services integration, and statistical products to biotechnology and pharmaceutical markets • Managed territory with $14M in annual sales, onboarded 10 new logos with 66% win rate on RFPs, delivered 33% growth, including 88%+ expansion on existing accounts within 3 months• Partnered with C-suite to define multi-year sales strategy, targets, and provide market analysis that informed account prioritization, pricing, promotional, and product decisions• Aligned Sales, Marketing, Finance, and Legal teams to plan and execute cross-channel outreach strategies and marketing campaigns, which increased lead generation and amplified brand awareness • Designed white papers, infographics, and print/digital materials to nurture leads at each stage of the funnel, and educate prospects on clinical processes from pre-clinical to regulatory submission • Track top market players in territory to monitor trends and adjust sales plans

• Managed team of 7 responsible for SDLC timelines for 3 studies (reported to President and VP)• Evaluated, negotiated, and initiated vendor/CRO contracts • Managed vendor quality and services throughout the milestones for each trial.• Partnered with CTMS, ePro software management of national and global sites.• IVRS/IXRS system manager, URS, UAT development.• Developed recruitment strategies, managed study budgets setup and ePRO systems support.

As the West Coast Director of Development, I partnered with pharmaceutical and biotech clients to lead specific projects requiring a broad range of commercialization services for success. At our facility in West Bend, Wisconsin, we operated a 200-bed Phase I clinical pharmacology unit (including 96 telemetry beds). Key Leadership Achievements: • Oversaw $9.6M in sales including strategic management, operational marketing, and customer relationship activities of the western United States for Phase I, Core Lab, Clinical Lab, and Biometric services.• Surpassed established goal by $3.8M and grew territory to $6.8M in year one by increasing mutable RFIs from companies including RJ Reynolds, Sentier Pharma (biosimilars), and Gilead.• Generated product development ideas including marketing materials, social media outreach, webcast, white paper, and other creative content for west coast markets; provided market feedback to company leadership regarding competitive offerings and prospect needs.

NAMSA is leading contract research organization (CRO), and the world’s only medical research organization (MRO), providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers.• Directed business development strategies for the world’s only medical research organization, providing expert preclinical, regulatory, laboratory, clinical, and compliance services to medical device manufacturers • Built and maintained partnerships across ecosystem with scientists, biostatisticians, medical writers, clinical researchers, compliance experts, and manufacturers providing research/data to grow clients’ awareness of clinical operations• Preferred thought partner for C-level decision-makers and R&D leaders to bring leading-edge, AI-powered medical devices to market from initial concept through to clinical trial, FDA approval & GTM o Advised management on each stage of product development and launch to offer critical inputs that enabled the commercialization of new devices and pharma products across EU, Japan, China, and South Korea• Analyzed clients’ product portfolios, strategies, competitive developments, consumer insights, and regulatory landscapes to drive commercial planning, positioning, and pricing that generated 42% growth YoY (23% in California market)

As the Director of Business Development, I established and expanded new business opportunities in California, Oregon, Washington, Nevada, Arizona, Utah, Montana and Idaho within the established account and prospective clients. As a senior leader for both the Biometric and Clinical teams, I was able to develop respect from sponsors to achieve mutually beneficial goals. Key Leadership Achievements:• Oversaw $4.6M and exceeded the corporate goal of $1.5M during the first 6 months, reaching $6.8 million within 12 months with contracts ongoing till 2017. • Average of 1.5 RFPs per week 68% hit rate selling Phase II, III, and IV full services.• Brought in new business to establish Veristat on the west coast, liaised between senior leadership for both Biometric and Clinical teams to develop and consult sponsors on achieving their goal

As a Senior Clinical Project Manager, I independently managed 3 plus complex multi-center clinical trials, including 103 sites and 5 direct reports, working in a Functional Service Provider (FSP) partnerships. I mentored other members of Statistic, Regulatory and Medical writing teams to achieve a common goal. Assuring proper training, planning, timely initiation/completion and high-quality documentation. In addition, I provided key coordination role with the Sponsor, CRAs, Business Development, Recruitment, Management, BioStats, QA, Data Management, Vendors and Medical Communications departments. Key Leadership Achievements: • Cross-functional leader on all medical & clinical work streams including clinical management strategies, proper resourcing for assigned trials, clinical operations, regulatory affairs, corporate compliance plan, and investigative sites' adherence.• Provided clinical leadership and served as the top representative for clinical development, presenting clinical trends, outcomes, and study closeouts to both internal and external stakeholders.• Cultivated strong collaborative relationships with investigators, site staff, and vendors throughout the life of assigned clinical trial(s) including vendor selection, outsourcing specifications, and managing the full scope of work

As the Director of Global Business Development, I identified strategic business opportunities, developed new business pipelines, assisted in new business presentations, closing business deals and attaining annual revenue goals. In addition, I cultivated relationships with current clients as a means towards growing MedPoint digital annual revenues with current clients.Key Leadership Accomplishments:• Oversaw $6.5M in sales & acted as Global Compliance Lead on first-in-class GCP compliant eClinical systems (EDC, Data Management, Portals, Virtual Investigator meetings, Issue escalation tool (CAPA) & rSDV).• Supervised deliverable management and development of all eClinical solutions for application to real-time clinical trial environments (21CFR11) compliant.• Spearheaded and developed sponsorship efforts and secured two global corporate sponsors; funding 10-20% of annual revenues and value engineered 80% of the new product line.

As the Clinical Systems Manager, I created (FSP) partnerships, clinical project management, trial site management, and global site management for an international biotech company focused on orphan drugs. • Led clinical project management for 8 clinical drug trials, reviewed and improved protocols, consent forms, and performed-risk based analysis defined on protocol endpoints. Trained clinical research coordinators & associates in timeline management, maintenance, and eMerge healthcare solution.• Negotiated vendor/FSP/CRO contracts and institution site selection including SOW and RFP. • Supervised Process mapping, SOW, RFPs, for IXRS, CTMS, OC, EDC with ePro integrations with vendors.• Liaised with related URS, UAT, and PQ Process Mapping and consistently initiated systems “Go Live/First Patient In” ahead of time and closed study on time with quality data.• Collaborated with ministers of health and university institutional officials to further promote study I built and disseminated information to major stakeholders including SET, CTM, CRO, CLO, IT, QA to ensure appropriate management of systems based on current study needs.Key Leadership Achievements: • Defined key process gap and provided quality improvement based on gap analysis, assessed deviations, and best practice by utilizing process improvement methodology to measure current state and implement strategic improvements.• Drove the change management process to ensure acceptance and adoption of new processes to include implementation of Greenphire, ePayment solution and card design.• Supervised study teams and maintained comprehension of CLO, IT, CSV, QA, VAL, CRO, and BUS with real-time Clinical System Validation Overview CSV.

As the Director of Global Clinical Programs, I led global clinical operations teams, including 8 direct reports based in the USA and South Korea. I developed operational plans,SDLC, including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management, studies Phase I, II, & III in Oncology, Diabetes II, Parkinson’s disease, ALS, Buerger’s disease, and tissue regeneration for treatment of DJD associate with genetic diseases such as acondroplasia with allergenic cord blood derived stem cells. • Built and validated investigator portal in Korea and USA, to allow management and investigators real time “dash board” view. • Established key relationships, selected and validated EDC (Medrio) and IVRS (Bioclinica) systems, initiated advertisement and staff incentives to speed enrollment sites.• Presented to the Deputy Minister of the KFDA current GCP monitoring best practices, reviewed in-house SOPs for monitoring of data integrity, good document practices, electronic data capture and IVRS systemKey Leadership Achievements:• Oversaw US & Korean executive boards for all quality improvement projects for both academic and private healthcare institutions including global project management and operations for six clinical teams.• Led and organized global SET teams ensuring 44 sites in Korea were fully compliant with ICH-GCP.• Strategized and implemented solutions for direct reports to employ effective site initiation, subject enrollment, clinical supply management, monitoring of CRF, risk mitigation strategies, and study close.

Essential instructor appointed to coach students in ICH/ GCP,GxP, 21 CFR/ 45CFR46 and Clinical Trial Management (i.e. monitoring and auditing skills, site selection, CRO and SMO negotiation, and delicate, "Real Life" operations surrounding research and site management) based on CFR regulations. Students included MDs, PhDs, CEOs of medical companies, managers, CRAs, CRCCs, RNs, and other industry professionals. • Presented a five-day (on weekends), extensive course in regulatory processes and laws of clinical research, GCPs, and related ethical principles, including the Belmont report, ICH laws, IRB laws and regulations, as well as protocol and consent development.

• Tasked with spearheading a project that had been outsourced to a vendor and participating in multiple clinical operation initiatives. • Reviewed and managed proposals and selection of CRO, assessing and developing protocols, establishing timelines, selecting an investigator and managing trial's progress.

• Onboarded and charged Project Management and Development leveraging in-depth knowledge in research and development to conduct extensive PMA global clinical study for three Class III devices. • Developed timelines and managed budgets, including site cost and supply chains.• Oversaw direct reports from the Institutional Review Board (IRB), CROs, FDA, Center for Biologics Evaluation and Research, and one National Institutes of Health (NIH) cooperative.• Clinical Trial manager lead, monitor lead, and manager for designing group infrastructure and strategic processes for 11 Clinical trials; 3 trials where cooperative studies completed on time & under budget.

Associate (part time) with a certified IRB, Mentored by Erica Heath, CIP. I was skilled on Clinical Trial Ethics, Belmont Report, 21CFR's, 45CFR46 and ICH "GCP""GDP" "GMP" and IACUC laws and regulations. Along with proficiency in International ethical regulatory bodies, there govern and organization

Recruited from CRA up to a senior level position and challenged to lead business development initiatives with various pharmaceutical companies. As a CTM I was given full accountability for performing site selection, protocol implementation, trial monitoring and closeout procedures. • Provided hands-on leadership and active participation in the launch and management of a $2.5M clinical research organization with 16 employees.• Conducted more than 40 trials for cardiac devices (pacemakers, stents, catheters, adhesives, and CAPG) as well as pharmaceuticals (oncology, dermatology, neurology, and general practice.)• Captured and formed strategic alliances with St. Vincent Hospital (LA) and Sharp Hospital (San Diego) to conduct join clinical trials.• Recognized as the first line of contact for SAE/AE reporting.• Contributed value-added thought leadership while supervising a team of 74 investigators in a 3,000 patient international device trial for organ transplant.