Senior Director, Medical Affairs
2 days ago
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Job Summary:The Senior Director, Office of Medical Affairs (OMA) is responsible for overseeing the scientific communications, investigator-sponsored research (ISR) program, and medical information management for Shockwave Medical products. This role requires frequent interaction with internal business partners and scientific key opinion leaders, and the entire OMA team must maintain strong working relationships.
Key Responsibilities:- Develop and implement OMA operating procedures that support regulatory and practice guidelines.
- Participate in the Clinical and Medical Affairs leadership team and ensure alignment within the team.
- Provide scientific insight into corporate objectives, evidence dissemination, and the value of Shockwave Medical products in the treatment of calcified cardiovascular disease.
- Responsible for the creation, execution, and communication of the clinical evidence dissemination plan.
- Interpretation of clinical data to assess the safe and effective use of Shockwave Medical medical devices.
- Create scientific presentations for physicians and business partners and oversee medical writing of manuscripts for evidence dissemination.
- Support the complaint reporting process in collaboration with the CMO and Quality department.
- Understand imaging-based modalities for assessment of device performance following lithotripsy-enhanced therapy, including angiograms, IVUS, and OCT studies.
- Develop and propose future data collection needs to further support/validate science and clinical outcomes.
- Make recommendations to optimize lithotripsy procedure based on clinical results.
- Conduct review of clinical cases for root cause analysis of individual outcomes.
- Partner with cross-functions, including R&D, on product performance.
- Participate in the authorship and review of clinical study documents for Clinical Affairs.
- Educate the field sales force and internal partners on relevant clinical data results.
- Oversee the ISR program, complete scientific review of ISR proposals, manage the ISR committee, and provide timely feedback to physicians.
- Respond to unsolicited scientific requests, linking Shockwave Medical scientific data to real-life physician practice to meet customer needs.
- Manage key opinion leaders; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
- Minimum Bachelor's Degree in a scientific field of study. Advance degree strongly preferred (PhD, MD, PharmD, etc.).
- Minimum 12 years' experience directly supporting clinical research or relevant experience in medical/scientific area.
- Strong leadership skills coupled with excellent management history with a minimum of 5 years' experience managing others.
- Medical device industry experience in cardiovascular medicine.
- Strong knowledge of FDA and international regulations and guidelines, including but not limited to clinical investigations, GCPs, SOPs, submissions, product launch, labeling, advertising, and promotion, product vigilance, unapproved use, and ADVAMED Code.
- Knowledge of International Committee of Medical Journal Editors (ICMJE) guidelines.
- Ability to develop and maintain key opinion leader relationships.
- Effective performance on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such.
- Effective written, verbal, and presentation skills across various audiences.
- Operate as a team or independently while maintaining flexibility and resilience.
- Ability to travel up to 40% of the time both domestically and internationally.
- Statistical analysis methodology and tools.
- High attention to detail and accuracy, good prioritization, and organizational skills.
- Excellent critical thinking skills.
- Excellent influencing and negotiation skills.
- High energy and results-oriented individual who is successful in a business environment and is skilled in motivating and inspiring people.
- Entrepreneurial hands-on experience. Pro-active and can-do attitude.
- Ability to work in a fast-paced environment while managing multiple priorities.
- 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
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
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