Mindy Vander Leest Email and Phone Number
WHO AM I?I bring medical devices to market!!The most interesting part is that I am not in sales or marketing. I'm actually an action-focused and solutions-oriented clinical research professional. I bring products to market through efficient and effective clinical research, and my passion extends beyond initial FDA clearance. With deep knowledge of post-market requirements, I ensure ongoing compliance and evidence generation to support product success throughout its lifecycle.My proven track record of success has been demonstrated at venture capital backed medical device companies all the way to Fortune 500 companies. I have designed clinical strategies that resulted in successful CE Mark and IDE approvals for multiple companies. I am highly skilled in creating, launching, and completing quality clinical trials. I have built clinical research departments and I have transformed at-risk clinical trials.WHAT DO I BRING TO THE TABLE?Forward-looking strategic clinical leadershipConsistent achievement of objectives that increases shareholder valueDedication to organizational goals Expert presentation, negotiation, and communication skills Proven ability to build new and maintain business relationshipsIntelligent, articulate and driven to succeedEnergized by new challengesGlobal Clinical Trial Execution:• US• OUS - Germany, France, UK, Belgium, Canada, Italy, Switzerland, Brazil & many more countriesRegulations:• FDA • ISO • GCPTypes:• PMA • IDE • 510(k) • CE Mark • Post Market • Registry •MDR • Limited Commercial ReleaseTherapies:• Orthopedic • Spine • Cardiovascular • Vascular • Stroke • Structural Heart • Atrial Fibrillation • Robotic Navigation • Cardiac Arrhythmias • AAA • Neurology KEY EXPERTISE:Clinical Trial Strategy, Design & Global ExecutionEvidence GenerationClinical Quality Assurance & Risk ManagementSOP Development & Compliance AuditsCross-Functional Team LeadershipPatient Safety & Adverse Event ManagementBudget Management & Resource OptimizationVendor & CRO ManagementContract Negotiations and HCP ComplianceClinical Team Training & BuildingIndependent ConsultingMonitoringLet’s Connect:I am always open to connecting with industry peers, sharing insights, and exploring new opportunities to drive clinical research forward. Let’s collaborate to bring innovative therapies to patients and ensure the highest standards of clinical quality.CONTACT ME:mindy.carlson.5@gmail.com
United Orthopedic Corporation
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Senior Director Of Clinical AffairsUnited Orthopedic Corporation Jul 2015 - PresentIrvine, California, UsServe in a clinical affairs leadership role for an international medical device company with a focus in orthopedics. Collaborates with a cross-functional, multi-disciplinary team to meet milestones and objectives. Sets strategic design to support regulatory submissions for multiple clinical studies in the United States. - Designed and currently executing multiple post-approval studies- Authored Post Approval Surveillance Plan- Built entire clinical department infrastructure, supporting documents, and hired team clinical research team- Coordinates resources to ensure efficient subject recruitment, study site selection, study plan optimization and execution of studies with a focus on quality- Manages clinical team operations including clinical strategy development, KOL target list, recruitment and enrollment- Provides clinical review of reports, regulatory submissions, publications, marketing materials, and technical manuals- Maintains multi-million dollar budgets on time and within target- Understands and and keeps abreast of trends in clinical research, health economics, reimbursement policies and regulatory requirements- Evaluates, trains, and manages professional relationships with academic and community-based physicians, clinicians and investigators- Targets top customers and thought leaders; ensures they remained engaged supporters of the company's therapies- Drives timelines, budgets, forecasts, clinical trial contract negotiations and reimbursement- Hires and manages external resources: vendors (CROs), core labs, consultants, clinical database, and statistics, and- Creates tools to provide consistent communication to executive team as it relates to clinical trial activation, monitoring, and data compliance.
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FounderConverge Research, Llc Jan 2014 - PresentProviding clinical trial services to medical device companies internationally and in the United States in accordance with ISO, GCP, and FDA regulations. Converge Consulting will provide expert planning, management, preparation and execution of clinical trials. Very experienced in clinical trial design, strategy development, clinical trial operations, study management, and monitoring for both pre-market and post-market studies. Specialize in startup medical device companies.A sampling of services provided:- Clinical Trial Planning and Design- Clinical Strategy Development- Protocol Development- Case Report Form Development- Clinical Infrastructure Development - Program/Project Management- SOP Development and Training- Clinical Monitoring and Auditing- IRB Submissions and Informed Consent Review- Clinical Trial Rescue- Post Approval Study Design and Execution- Identify/Evaluate Clinical Sites/Investigators- Conduct Investigator and Site Training- Contract Negotiation with Investigators/Vendors- Core Lab management- CEC/DSMB management - Forecasting and Budgeting- Clinical Review of Marketing, Technical Documents and Publication- Report writing -
Director Of Clinical AffairsZyga Technology, Inc Feb 2012 - Dec 2013Served in a clinical affairs leadership position at a startup medical device company with a focus in orthopedics. Collaborated with a cross-functional, multi-disciplinary team to meet milestones and objectives. Set strategic design to support regulatory submissions for 5 studies including IDE and post-approval clinical trials internationally and in the United States. - Authored FDA IDE feasibility study leading to successful approval to begin study- Authored successful clinical CE Mark submission- Authored multiple post-approval studies- Authored Post Approval Surveillance Plan- Built entire clinical department infrastructure, supporting documents, and hired team of 2 CRAs- Coordinated resources to ensure efficient subject recruitment, study site selection, study plan optimization and execution of studies with a focus on quality- Managed clinical team operations including clinical strategy development, KOL target list, recruitment and hiring of Medical Advisor and CEC members- Provided clinical review of reports, regulatory submissions, publications, marketing materials, technical manuals, and timely review of ECOs- Significantly reduced costs associated with database build and management- Understood and kept abreast of trends in clinical research, health economics, reimbursement policies and regulatory requirements- Evaluated, trained, and managed professional relationships with academic and community-based physicians, clinicians and investigators- Targeted top customers and thought leaders; ensured they remained engaged supporters of the company's therapies- Drove timelines, budgets, forecasts, clinical trial contract negotiations and reimbursement- Hired and managed external resources: vendors (CROs), core labs, consultants, clinical database, and statistics- Created tools to provide consistent communication to executive team and board members on clinical trial activation, monitoring, and data compliance.
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Clinical Programs ManagerAga Medical Jan 2010 - Feb 2012Plymouth, Mn, UsAGA Medical now St. Jude MedicalLed a complex clinical program for percutaneous, transcatheter medical devices for structural heart while managing a high performing staff of 16 in order to execute global clinical research involving 1200 subjects at 115 hospitals.- Built relationships with a variety of key physicians; identified top thought leaders and created unique way to effectively reach out to their offices to drive subject enrollment and recruitment- Authored Post Approval Surveillance Plan- Trained and prepared internal team members as well as clinical and site personnel for FDA/BIMO audits - Managed PMA creation and authored sections- Led department wide LEAN process improvement initiatives for BIMO audit preparedness and training and SOPs- Created milestones and drove timelines for clinical team and ensured all goals were achieved on time and within strict budgetary framework while providing mentoring and coaching- Represented Clinical Affairs on cross-functional teams and with regulatory agencies- Ensured compliance with SOPs, regulations and internal guidelines in alignment with business priorities- Drove clinical trial contract negotiations and reimbursement -
Director Of Clinical ResearchDisc Dynamics Aug 2004 - Jan 2010Eden Prairie, Mn, UsServed in a clinical affairs leadership position at a startup medical device company with a focus in orthopedics (disc nucleus replacement device) successfully obtaining CE Mark and FDA IDE feasibility study approvals while managing a staff of up to 4 internal employees for US and OUS studies.- Authored FDA IDE feasibility study leading to successful approval to begin study- Authored successful clinical CE Mark submission- Authored successful post-approval study along with completion of the study- Authored and submitted clinical reports for regulatory, safety and ethics reports as required by law- Built entire clinical department infrastructure, supporting documents, and hired team of 4 CRAs- Supported multiple FDA submissions- Developed and executed global clinical research in collaboration with marketing and other cross-functional team members- Executed clinical research protocols and supporting documentation to support global business needs- Developed and managed external resources: vendors (CROs), consultants, DSMB, monitors, and statistics- Drove clinical trial reimbursement and negotiated clinical trial agreements, budgets and contracts- Provided training for internal and external team members including investigators and staff, clinicians, and OR in-servicing and case support -
Manager, Clinical ProgramsSt. Jude Medical 2002 - 2004St. Paul, Minnesota, UsResponsible for study management and monitoring for 50 US and OUS clinical sites in the cardiac surgery division (stented and stentless tissue valves). Role required targeting and executing investigator and site participation, IRB submissions, in-servicing the OR, monitoring, DSMB meetings, device accountability, enrollment/recruitment rates, competitive intelligence, data submission and protocol compliance. Started as a Senior Clinical Research Associate (CRA) and was promoted to a management position. -
Clinical Research AssociateTeramed 2000 - 2002Clinical Research Associate (CRA) responsible for global clinical study including monitoring from site initiation through close-out, IRB and EC submissions, device accountability, site and physician training, enrollment/recruitment, data submission, adverse event reporting, query resolution, and protocol compliance.
Mindy Vander Leest Education Details
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University Of MinnesotaBachelor Of Science (Bs) -
Iowa City City High
Frequently Asked Questions about Mindy Vander Leest
What company does Mindy Vander Leest work for?
Mindy Vander Leest works for United Orthopedic Corporation
What is Mindy Vander Leest's role at the current company?
Mindy Vander Leest's current role is Clinical Research Leader | Expert in Trial Strategy, Management & Execution | CRO Founder.
What schools did Mindy Vander Leest attend?
Mindy Vander Leest attended University Of Minnesota, Iowa City City High.
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