Senior Clinical Research Scientist

Primary Duties and Responsibilities

• Represent Anteris as an industry leader within scientific, clinical research, and industry organizations
• Serve as a Scientific Lead and Subject Matter Expert for Anteris-sponsored clinical studies
• Possess cross-functional expertise to support the scientific objectives of Anteris-sponsored clinical studies and advance the company’s mission as a science-driven organization
• Oversee the subject selection process to ensure accurate and timely review of subject eligibility criteria, with oversight from clinical leadership
• Drive effective cross-functional collaboration with external vendors
• Contribute to clinical trial design, protocol development, protocol revisions, and reports supporting regulatory submissions, with guidance from clinical leadership
• Participate in publication planning activities in collaboration with cross-functional stakeholders
• Develop, maintain, and review clinical study reports and related documentation
• Deliver timely study updates to clinical and cross-functional leadership through clear, well-structured presentations and data summaries
• Contribute to root cause analyses, corrective and preventive actions, and effectiveness monitoring, with oversight from clinical leadership
• Collaborate with internal and external stakeholders, including study sites, vendors, and committees, to support clinical trial objectives and appropriately escalate issues when needed
• Build and maintain strong relationships with study investigators and key opinion leaders
• Contribute to Medical Legal Review (MLR) activities as a clinical subject matter expert for external data releases, ensuring scientific accuracy and appropriate clinical interpretation prior to publication or disclosure
• Compile clinical documentation and data for regulatory submissions
• Provide cross-functional clinical training and education support

Required Education & Experience

• Advanced degree in Life Sciences required; MD or PhD preferred
• 5+ years of Clinical Science or Clinical Research experience within cardiology, cardiovascular, or medical device environments
• Experience contributing scientifically to medical device clinical trials
• Proficiency in medical terminology and medical writing, including experience working within ICMJE guidelines
• Knowledge of healthcare ethics and compliance regulations
• Strong work ethic, self-motivation, collaboration skills, and excellent written and verbal English communication skills

Preferred Skills, Knowledge, Experience & Qualifications

• TAVR clinical research experience strongly preferred
• Extensive clinical or scientific experience with advanced training in research, study design, and statistics (MSN, PhD, MS, or equivalent)
• Experience with imaging modalities, including echocardiography, CT, and CMR interpretation
• Experience supporting international, multi-center, randomized clinical trials
• Experience with statistical software programs such as Matlab, SPSS, or SAS is a strong plus

What We Offer

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies
• A collaborative and dynamic work environment with a culture of innovation and excellence
• Competitive compensation package, including salary, performance-based bonuses, and stock options
• Career development opportunities and a chance to be part of a growing company that values its employees
• Health and Wellness Offerings: Medical, Dental, and Vision Plans, Flexible Spending Account (FSA), 401k + Company Match, Life, AD&D, Short-Term and Long-Term Disability Insurance, Bonus Plan Eligibility, Employee Equity Program, Paid Holidays & Vacation, Employee Assistance Program
• Inclusive Team Environment
• Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
• We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization.