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
- Lead and develop a diverse team of clinical professionals to ensure a consistent approach to clinical operations.
- Partner with cross-functional clinical partners to meet business objectives.
- Obtain in-depth knowledge of clinical issues that may impact clinical and business objectives.
- Maintain strong relationships through direct interactions with medical advisors and clinical leaders.
- Lead internal clinical research teams to ensure milestones are met. Coach and mentor the team to maximize performance.
- Oversee the performance of CROs and external research partners to ensure study integrity and business milestones are met.
- Design and execute global studies for regulatory submissions, reimbursement and product adoption.
- Ensure data integrity during conduct of study, oversee clinical data analysis, clinical study reports and participate in evidence dissemination.
- Oversee administrative activities associated with the clinical department including development and maintenance of clinical procedures, hiring and training of key personnel, and preparation and maintenance of objectives and budgets.
- Medical device experience in cardiovascular, highly preferred.
- Other duties as assigned.
Requirements
- Minimum Bachelor's Degree in a scientific field of study.
- Minimum 15 years' experience directly supporting clinical research including 5+ years of people leadership.
- Must have medical device experience.
- Cardiovascular medical device experience, highly preferred.
- Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
- A history of effective collaboration with regulatory agencies through clinical studies and market releases.
- Strong knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting.
- Excellent prioritization and organizational skills.
- High attention to detail and accuracy.
- Finance and budgeting knowledge.
- Excellent critical thinking influencing and negotiation skills.
- Works effectively on cross-functional teams.
- Effective written, verbal and presentation skills with all levels of management and organizations.
- Operate both as a team and independently, with adaptability to changing requirements.
- Ability to work in a fast-paced environment, managing multiple priorities.
- Ability to travel 30-40% domestically and internationally as needed.
- Employee may be required to lift objects up to 25lbs.
Market Range:
San Francisco Bay Area (SFBA) Market Range:$248,000 - $310,000
All Other US Locations (Outside of SFBA): $211,000 - $264,000
Exact compensation may vary based on skills, experience, and location.
Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer
