Vice President, Biometrics
19 days ago
Miami
Job DescriptionAbout Us Longeveron Inc, a publicly traded (NASDAQ: LGVN), clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, with our headquarters located in Miami, FL. Our lead investigational product is laromestrocel, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult rare diseases and conditions associated with aging About the Role The Vice President, Biometrics, is a key member of the R&D leadership team and is responsible for providing strategic, scientific, and operational leadership for all biometrics functions, including Biostatistics, Statistical Programming, and Clinical Data Management. This leader will ensure the generation of high-quality clinical data to support development decisions, regulatory authority submissions, publications, and commercialization efforts. The role requires cross-functional collaboration, strong regulatory engagement, and visionary leadership to build scalable biometrics capabilities that align with the company’s mission and growth objectives. **This role is not available for sponsorship, including I-983 participation. What You’ll Do Strategic Leadership • Define and execute the biometrics strategy in alignment with clinical development, regulatory, and corporate goals., • Act as a thought leader and internal consultant on statistical and data-related topics across the pipeline., • Provide critical input into clinical development strategies, including endpoint selection, adaptive design considerations, and integrated evidence plans.Operational Oversight, • Lead and manage Biostatistics, Statistical Programming, and Data Management teams across all stages of clinical development., • Oversee the development of statistical analysis plans (SAPs), mock shells, and data presentation standards., • Drive innovation in biometrics methodologies and tools, including advanced analytics, real-world data integration, and digital biomarker strategies.Regulatory Support, • Represent Biometrics in regulatory interactions, including FDA, EMA, and other global agencies, and in advisory committee preparation., • Oversee the development of regulatory submission packages (e.g., ISS/ISE, CSR outputs, and electronic data submission packages including CDISC).Vendor and Resource Management, • Develop and execute vendor strategy for biometrics services, ensuring cost-effective and high-quality partnerships., • Monitor CRO/vendor performance, budgets, timelines, and deliverables., • Optimize resource allocation, operational efficiency, and risk mitigation for internal and outsourced activities.Cross-functional Collaboration, • Partner with Clinical Operations, Regulatory Affairs, Medical Affairs, RWE, and IT to ensure data integrity, compliance, and strategic alignment., • Contribute to due diligence evaluations and integration planning for business development or licensing opportunities.Quality and Compliance, • Ensure that all biometrics deliverables are completed in accordance with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements., • Champion process improvement initiatives and best practices to enhance data quality and efficiency.People Leadership, • Build, lead, mentor, and inspire a high-performing, agile biometrics organization., • PhD or MS in Biostatistics or Statistics,, • Minimum 15+ years of experience in biometrics roles within the pharmaceutical or biotechnology industry, • At least 8 years in leadership or management roles overseeing biostatistics, programming, and/or data management functions, • Proven experience supporting regulatory submissions, including NDAs/BLAs or MAAs, • Deep understanding of CDISC standards (SDTM, ADaM), clinical trial design, and statistical methodologies, • Demonstrated success in building and leading high-performing teams in a matrix environment, • Strong vendor management and outsourcing strategy experience, • Excellent communication, strategic thinking, and stakeholder engagement skills, • Competencies: Learning agility, critical thinking, collaborative team player and leader, operational excellence, results-driven, • Ability to travel up to 20% based on the needs of the business, • Medical, dental and vision benefits (employee premiums covered at 100% and up to 95% coverage for spouse, child, or family plans), • 401(k) plan with company match, • Generous paid time off plan and company holidays, • 2 paid company shutdowns (winter and summer), • Employee assistance program Longeveron is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Longeveron, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Powered by JazzHR 3HsFFJggjZ