Sr. Director, Clinical Affairs (Shared Services)
Shockwave Medical | |
life insurance, 401(k) | |
United States, Minnesota, Minneapolis | |
Sep 27, 2024 | |
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview
The Sr. Director of Clinical Affairs for Shared Services will play a key leadership role as the company continues to transform the treatment of poorly served patient populations with paradigm changing technologies. The role will be responsible for managing a complex and diverse group of teams that support the intravascular lithotripsy (IVL) and Reducer Clinical Affairs franchise. Shared Services includes Data Management and Statistics, Safety, Project Management, Clinical Evaluation Report (CER) medical writing, and Clinical Quality. The candidate will work with Clinical Affairs leaders of the therapeutic teams, Medical Affairs, cross-functional partners and other external stakeholders including regulatory bodies and contract research organizations. The individual will be responsible for building and maintaining a high-functional clinical team and for the oversight of external research partners. Significant hands-on oversight of complex clinical studies and implementation work is required in this role.
The Sr. Director of Clinical Affairs for Shared Services will come with a background in clinical operations. The candidate should have experience with cardiovascular medical devices and cross-functional clinical core teams. This candidate is accountable for consistent and standardized execution of clinical programs across the business, for providing work direction to in-house clinical staff, and for successful completion of clinical milestones in compliance with applicable regulatory and business standards. The candidate is responsible for coordination with cross-functional counterparts and contract research organizations (CROs) across global studies in conformance with applicable regulatory requirements to meet business objectives. The Sr. Director for Shared Services will establish processes and best practices, in addition to maximizing metrics and reporting on clinical activities. Significant interactions with external stakeholders and study staff are required to ensure the clinical data reported are complete, accurate and true.
This position requires critical thinking skills with respect to program strategy and clinical operations execution to evaluate the safety and effectiveness of new and existing products. This work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and has significant impact to the business.
Essential Job Functions
Requirements
Market Range: San Francisco Bay Area (SFBA) Market Range:$248,000 - $310,000 Exact compensation may vary based on skills, experience, and location. Benefits |