Job Listing
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| Job ID: 13995308 |
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| Job Location: |
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| How to Apply: | To see employer contact information, log in or register. |
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| Job Title: | Director, Clinical Affairs |
| Work Type: | Work Days: Work Vary: Yes , Shift: Other, Hours Per Week: 40, Work Type: Regular |
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| Salary Offered: | Unspecified |
| Benefits: | Unspecified. |
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| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | Bachelor's Degree |
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| Experience Required: | Unspecified |
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| Required Skills: | Please see the job description for information about required job skills. |
| Preferred Skills: |
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| Job Description: |
Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the recent acquisition of Neovasc and their innovative Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina - long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. Together, we are working to bring these patients relief from their symptoms and hopefully improve their quality of life.
Position Overview
The Director of Clinical Affairs will play a key leadership role as the company continues to transform treatment of poorly served patient populations with paradigm changing technologies. This role will require clinical and scientific input into cross-functional product development core teams and with physician advisors. Significant hands-on oversight of complex clinical studies and implementation work is required in this role.
The Director of Clinical Affairs will come with a background in creating and executing clinical strategy and influencing internal and external customers within the product development team to drive business results. The candidate should have experience with cardiovascular medical devices and cross-functional product development core teams including risk management and clinical strategy.This candidate is accountable for clinical study management activities, 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 Director of Clinical Affairs will establish processes and best practices, in addition to maximizing metrics and reporting on clinical activities.Significant interactions with physician investigators and study staff are required on the use of Shockwave Medical products during the clinical investigation 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
Develop and execute clinical strategies
Design and execute global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management activities.
Obtain in-depth knowledge of clinical issues that may impact clinical and business objectives.
Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
Responsible for compiling clinical reports and other data summaries required to support regulatory submissions.
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.
Responsible for coaching and supporting the development of subordinates.
Oversee clinical data analysis and review.
Effectively report the clinical data and participate in evidence dissemination planning.
Partner with cross-functional partners in product development to meet business objectives.
Leadership of internal clinical research teams and CROs to deliver on business objectives.
Other duties as assigned.
Requirements
Minimum Bachelor's Degree in a scientific field of study.
Minimum 12 years' experience directly supporting clinical research including 5+ years of managerial experience.
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.
Computer skills (MS Office products, word processing, spreadsheets, etc.).
Finance and budgeting knowledge.
Excellent critical thinking skills.
Excellent influencing and negotiation skills.
High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people.
Entrepreneurial "hands-on" experience. Pro-active and "can do" attitude.
Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such.
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: $185,000 - $232,000
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: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer
Shockwave Medical Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
Refer to ID 78763261 when applying |
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