Director, Clinical Operations - Medical Device (510(k), PMA)

At Tempo Therapeutics, we are pioneering a new era in tissue engineering and regenerative medicine with our cutting edge Microporous-Annealed-Particle (MAP) technology platform. Our team is developing next generation biomaterials to build precision scaffolds for use in surgical reconstruction, organ regeneration, and even vaccine technology. Our mission is to harness the power of immunomodulation and use material science to transform the landscape of medical technology.

This is a unique opportunity to work in a fast-paced and challenging environment, while being an integral part of a team that is developing material science technology shaping the future of medicine. Our team is driven by the goal of changing patient lives for the better, and the successful candidate will share that driving force.

Job Summary

Responsible for leading and driving Clinical Operations strategy, design and execution in support of Tempo’s goals and objectives. This role oversees and leads the global Clinical Operations effort to ensure all assigned operational trial deliverables across programs are completed according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines.

Responsibilities

Oversees the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations.Hands-on management and oversight of multiple clinical trial study deliverables through clinical study teams and other external resources, such as contract research organization and laboratoriesActs as primary liaison to CROs and vendors for assigned clinical studies/programsCollaborative cross functional engagement with internal and external teams, including Tempo leadership, Regulatory Affairs, Quality Assurance, clinical sites and PIs.Development and implementation of clinical standard operating procedures (SOPs) to ensure compliance with FDA and international medical device GCP requirements while maintaining and improving operational efficiency.Oversight of CROs and external vendors to ensure proper conduct of all assigned clinical studiesProvide guidance to ensure SOPs are followed across all programs, including with CROs, outside labs, and other third-party vendorsAccountable for clinical trial site administrative activities, including site qualification, investigator agreements, CRO relationships, contract, budgets, timelines, metrics, site oversight and study close out activities.Identify additional resource requirements based on business needs to meet goals and milestonesMaintenance of clinical trial master files and other clinical documents to ensure inspection readiness at all timesMaintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systemsProactively assess potential risks to the study and propose mitigation plansOther projects as deemed appropriate

Qualifications

BS, BA in life science, medical or equivalent; minimum of 8 – 10 years of operations management in clinical research in medical device / med tech industry or clinical research site-based experienceWorking knowledge of FDA regulatory policies, procedures and requirements, Good Clinical Practice, ICH guidelinesProven experience leading clinical research activities in a medical device industryexperience with PMA and/or 510K submissions a plusExperience working independently and in a team environment, being flexible and adapting in a changing environmentAbility to multi-task/ prioritize and time management of daily activitiesIntermediate to advanced software skills (Microsoft Excel, PowerPoint, MS Project)High attention to detailAbility to travel up to 25%Interest in being part of an organization with excellent science and a culture of collaboration, teamwork and an entrepreneurial spirit

COMPANY CULTURE / Perks & Benefits

At Tempo we believe in investing in our team. Our benefits programs are just one of the many ways we strive to help our employees take care of themselves and their families. We offer a variety of programs, from comprehensive medical insurance to generous time off policies designed to help meet the needs of our diverse team.

Benefits include:-Competitive base salary and annual incentive opportunities-Equity participation-Comprehensive health and welfare benefits (including medical, dental, vision, disability, and accident insurance)-Paid time off and holidays-Flexible work arrangements-Environment where professional development is actively encouraged and supported.

Equal Opportunity Statement Tempo is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.