Senior Scientist, Clinical Development
About The Position
This unique position will serve as a scientific contributor for the development and execution of clinical research necessary to competitively position a product for domestic and international regulatory and clinical acceptance. You will be responsible for developing and delivering appropriate global evidence generation strategies (premarket studies, postmarket studies, investigator initiated, real world evidence) aligned to R&D, Regulatory, and Commercial needs. You will ensure input and strong alignment from key regional MedTech leads and other strategically important countries/regions in the development of clinical evidence generation strategies. You will contribute and support the design of appropriate studies to meet premarket and postmarket needs, review, analyze and present current literature on real-world evidence (RWE) studies, and meet US and EU regulatory requirements for post market studies. You will execute and oversee multi-centre clinical trials to meet milestones, strengthen capability in and drive implementation of real-world evidence to deliver cost-effective evidence solutions, and ensure appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc. You will support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical, preclinical, and regulatory strategy, including proposed studies; review process of evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections. You will demonstrate the ability to influence, shape and lead teams and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility. You will build successful relationships internally and develop partnerships with key business partners and customers/investigators.
Requirements
- A minimum of 5 years of related scientific / technical experience within clinical research is required.
- Experience in clinical science and processes along with an understanding of product development processes, related healthcare market environment, clinical trends, and/or clinical trial regulations is required.
- Proven track record of contributing to clinical programs on time, within budget and in compliance to SOPs and regulations is required.
Nice To Haves
- Experience working in Robotics is preferred.
- Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred.
Responsibilities
- Develop and deliver appropriate global evidence generation strategies (premarket studies, postmarket studies, investigator initiated, real world evidence) aligned to R&D, Regulatory, and Commercial needs
- Ensure input and strong alignment from key regional MedTech leads and other strategically important countries/regions in the development of clinical evidence generation strategies
- Contribute and support the design of appropriate studies to meet premarket and postmarket needs
- Review, analyze and present current literature on real-world evidence (RWE) studies
- Meet US and EU regulatory requirements for post market studies
- Execute and oversee mutli-centre clinical trials to meet milestones
- Strengthen capability in and drive implementation of real-world evidence to deliver cost-effective evidence solutions
- Ensure appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc.
- Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical, preclinical, and regulatory strategy, including proposed studies; review process of evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections
- Demonstrate the ability to influence, shape and lead teams and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility
- Build successful relationships internally and develop partnerships with key business partners and customers/investigators
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
