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Executive Director, Clinical Development (Medical…
- Bausch Health (Bothell, WA)
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Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
We are seeking an Executive Director, Clinical Development for our Medical Device Aesthetics business (Solta) to be a key contributor to the mission of improving lives through medical aesthetic technologies driven by science. Our products use a broad range of innovative laser and radio frequency technologies designed by our scientists and engineers to enable first-to-market applications and best-in-class products for dermatology.
As the leader of our development team, covering both pre-and post-approval studies, you will work closely with our R&D team, Global Strategic Marketing team, and the Regulatory team to champion the clinical development and science -generated evidence roadmap to expand clinical applications for existing products and be key contributor to the development of new product clinical indications through direct clinical study/validation. Additionally, this position will provide clinical support for regulatory approvals for new products and expand clinical applications for existing products. This leadership position will be responsible for overseeing and ensuring effective execution of product clinical trials ranging from feasibility to pivotal studies, through collaborations with leading KOLs. Will also drive our data dissemination program through peer-reviewed publications, white papers, and podium presentations at major conferences.
The ideal candidate would have experience managing and mentoring clinical research teams, extensive operational experience in all aspects of medical device clinical studies, and a strong track record of advancing clinical research. This position provides a unique opportunity to drive innovation through the development of new medical device technologies and applications in a fast-paced R&D environment.
Duties & Responsibilities:
+ Define and drive the clinical and medical study roadmap in alignment with Solta Medicals strategic objectives and partner effectively with R&D, Global Strategic Marketing, and Regulatory to execute a sound clinical strategy
+ Oversee the planning, execution, and reporting of all clinical and medical studies conducted through the collaborators (KOLs) and ensure studies track to budget and schedule to achieve the intended indications/claims
+ Integrate scientific knowledge and operational expertise to ensure the translation of clinical research plans into efficiently delivered high-quality studies
+ Serve as Solta Medicals clinical subject matter expert by developing a comprehensive understanding of our products' mechanisms of action, recommended treatment settings, clinical endpoints and outcomes, and contribute to the identification of differentiating features
+ Stay current with new developments in clinical applications, medical device technologies, and competitor products by attending conferences and reviewing clinical research literature
+ Define and drive a comprehensive clinical data dissemination plan to increase market adoption of Solta Medicals products through peer-reviewed journal publications, whitepapers, and podium presentations
+ Develop relationships with KOLs to collaborate on clinical studies, data dissemination, and new product development initiatives
+ Build, inspire, and mentor a clinical research and medical team to develop first to market and best-in-class directed energy medical systems for applications in dermatology and liposuction
+ Serve as an individual contributor as needed to help draft study protocols, monitor clinical studies, analyze study data, implement new clinical techniques, and support study sites
+ Prepare project updates for program reviews with the senior management team
+ Other duties as needed
Requirements & Qualifications:
+ BS in engineering or science (MS, PhD, or MD preferred) with at least 10 years of experience in clinical research for medical devices
+ At least 5 years of experience managing clinical research teams with a focus on leading by example
+ Extensive experience leading multiple concurrent clinical studies and collaborating with KOLs to drive publications and podium presentations
+ Demonstrated experience in pre-clinical model development
+ Basic knowledge of statistical analysis techniques used to design clinical studies and evaluate study results
+ Experience with concepts in one or more of the following areas is preferred: radio-frequency-tissue interaction, laser-tissue interaction, thermally induced tissue damage, laser tissue ablation, ultrasound-assisted liposuction
+ Excellent leadership and communication skills, initiative, and attention to detail and project deadlines
+ Strong understanding of Good Clinical Practice (GCP), industry practices, and regulatory standards
+ Ability to travel as needed
Additional Qualifications preferred
+ Demonstrated success in forming strategic partnerships with industry and academic collaborators
+ Collaboration with R&D in the development strategy to progress from proof of concepts to the animal model to first in human
+ Business development opportunity assessments
As required by law,Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is$225K to $280K per year.
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
Bausch Health is an EEO/AA employer M/F/D/V.
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Executive Director, Clinical Development (Medical Device Aesthetics)
- Bausch Health (Bothell, WA)