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熊猫简历Vice President, Clinical Affairs简历模板,简约、经典、上下结构风格简历模板,支持自定义板块、自定义颜色、AI润色、技能条、荣誉墙、一键更换模板,专业AI辅助一键优化Vice President, Clinical Affairs简历内容,仅需5分钟即可拥有一份精美的Vice President, Clinical Affairs简历模板,助力你获得「高薪职位」。

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Professional Profile

Leo Panda

Vice President, Clinical Affairs
PROFESSIONAL SUMMARY

Clinical affairs executive with 15+ years leading global clinical strategy, evidence generation, and regulated trial operations across medical device and biopharma environments. Proven record building high-performing teams, aligning clinical programs with FDA and EU MDR expectations, and translating data into portfolio, reimbursement, and commercial decisions.

KEY ACHIEVEMENTS
Expanded Clinical Portfolio Value

Established an evidence-generation framework supporting three new indications and more than $120M in forecasted revenue.

Strengthened Inspection Readiness

Created enterprise clinical quality metrics adopted by regulatory, quality, and medical affairs leadership for inspection readiness.

Improved Executive Decision-Making

Developed executive clinical dashboards that improved board visibility into enrollment risk, study cost, and evidence milestones.

PROFESSIONAL SKILLS
Clinical Affairs Leadership
Clinical StrategyEvidence GenerationMedical Affairs AlignmentKOL EngagementPublication Planning
Clinical Operations & Compliance
Good Clinical PracticeFDA IDEEU MDRISO 14155Risk-Based Monitoring
Executive & Commercial Partnership
Board PresentationsPortfolio PrioritizationReimbursement EvidenceBudget OwnershipCross-Functional Leadership
PROFESSIONAL EXPERIENCE
CardioNova Therapeutics
Medical DevicesCardiovascular Care
San Diego, CA
Vice President, Clinical Affairs
Clinical StrategyExecutive Leadership
Mar 2020 - Present
  • Directed global clinical affairs strategy for Class II/III cardiovascular device portfolio, aligning evidence plans with FDA, EU MDR, and commercial objectives across 12 markets.
  • Led 42-person clinical operations, medical writing, and biostatistics organization, improving site activation cycle time by 31% through standardized governance and risk-based monitoring.
  • Secured executive approval for a $48M clinical evidence roadmap, prioritizing pivotal trials, post-market surveillance, and health economics studies for reimbursement decisions.
  • Partnered with regulatory and quality leaders to close FDA pre-submission issues, reducing protocol revision cycles from five months to nine weeks.
  • Presented clinical risk-benefit updates to board and physician advisory panels, influencing portfolio continuation decisions and a successful Series E financing round.
HelixMed Technologies
Digital HealthClinical Trials
Boston, MA
Senior Director, Clinical Affairs
Clinical OperationsKOL Engagement
Jul 2015 - Feb 2020
  • Built clinical affairs function from the ground up, hiring 18 leaders and implementing SOPs, vendor oversight, and medical review processes.
  • Oversaw four multicenter IDE and post-market studies enrolling 2,600 patients, achieving 96% data completeness and zero critical audit findings.
  • Negotiated CRO and core lab agreements that lowered contracted study spend by 17% while maintaining enrollment targets and endpoint adjudication timelines.
  • Developed KOL engagement model across 75 investigators, increasing abstract submissions, podium presentations, and publication acceptance rates within two congress cycles.
EDUCATION
Johns Hopkins University
Clinical ResearchPublic Health
Baltimore, MD
Master of Science in Clinical Research Management
Sep 2009 - May 2011

Graduate research focused on clinical trial design, regulatory operations, and patient safety oversight.

University of Michigan
Life SciencesResearch
Ann Arbor, MI
Bachelor of Science in Biology
Sep 2003 - May 2007

Completed undergraduate research in human physiology and evidence-based medicine.

CERTIFICATIONS
Regulatory Affairs Certification, RAC-Drugs - Regulatory Affairs Professionals Society
May 2023
ACRP Certified Professional, ACRP-CP - Association of Clinical Research Professionals
Oct 2021

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