A leading research organization is seeking a Clinical Trial Design Specialist to design and develop clinical trials for cardiovascular therapeutics. Candidates should have an advanced degree and extensive experience in clinical trial design. The role emphasizes innovation and compliance with regulatory guidelines, offering flexible engagement opportunities, including remote work.
Leistungen
Flexible engagement opportunities
Global exposure
Qualifikationen
5+ years of experience in clinical trial design and development, preferably in cardiovascular disease.
Familiarity with biostatistics, trial modeling, and adaptive design methodologies.
Aufgaben
Lead the design, protocol development, and statistical framework for trials.
Collaborate with clinicians and biostatisticians to optimize trial endpoints.
Ensure compliance with FDA, EMA, and ICH guidelines.
Kenntnisse
Clinical trial design
Protocol writing
Regulatory interactions
Collaboration skills
Communication skills
Ausbildung
Advanced degree (MD, PhD, PharmD, or MSc) in Clinical Research, Medicine, or Life Sciences
Jobbeschreibung
Overview
Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam D'Angelo, Larry Summers, and Jack Dorsey.
Commitment: Flexible engagement opportunities (consulting or full-time)
Focus on designing and developing clinical trials for cardiovascular therapeutics. Emphasizes innovative methodologies and compliance with regulatory guidelines.
Responsibilities
Lead the design, protocol development, and statistical framework for Phase I–III cardiovascular and inflammatory disease trials.
Collaborate with clinicians, regulatory experts, and biostatisticians to optimize trial endpoints, patient selection, and study power.
Ensure compliance with FDA, EMA, and ICH guidelines for trial design and execution.
Review and incorporate real-world evidence, biomarkers, and emerging trial methodologies into study planning.
Support cross-functional teams in regulatory submissions, trial monitoring, and results interpretation.
Provide expertise in risk mitigation, adaptive trial design, and innovative methodologies.
Qualifications
Must-have qualifications: Advanced degree (MD, PhD, PharmD, or MSc) in Clinical Research, Medicine, or Life Sciences.
5+ years of experience in clinical trial design and development, with cardiovascular disease experience strongly preferred.
Proven experience in protocol writing, endpoint selection, and regulatory interactions.
Familiarity with biostatistics, trial modeling, and adaptive design methodologies.
Strong understanding of drug development across small molecules, biologics, and novel therapeutics.
Excellent collaboration, writing, and communication skills for multidisciplinary teams.
Engagement Details
Flexible engagement opportunities: Consulting or full-time
Remote work available
Global exposure
Application Process
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Resources & Support
For details about the interview process and platform information, please check: https://talent.docs.mercor.com/welcome/welcome
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