David L. Stark, Dc Email & Phone Number

Novato, CA, US

Hanover, Maryland, US

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.

Radnor, Pennsylvania, US

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.

San Diego, CA, US

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.

Fargo, North Dakota, US

• 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.
• 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

Cambridge, MA, US

• 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.
• 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

• 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.

West Bend, WI, US

• 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.
• 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.

Toledo, OH, US

• 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.
• 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.
• 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.
• 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.

Southborough, Massachusetts, US

• 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.
• 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.
• 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.
• 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.

Evanston, Illinois, US

• 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.
• 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.

San Rafael, CA, US

• 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 &.
• 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.

US

• 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.
• 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.
• 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.

Fremont, CA, US

• 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".
• 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.

South San Francisco, California, US

• 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

Pasadena, California, US

• 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.
• 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.

Bachelor Of Science (Bs), Biology, General

Doctor Of Chiropractic, Chiropractic

Post Doctoral Internship, Forensic Medicine

Education record

Education record