Senior Clinical Development Scientist
In this critical role, you will be providing clinical science insights and expertise across key Ideation-to-Market processes, from emerging clinical needs, trends and innovations, through co-creation and discovery, clinical research, and proposition roadmap. You will work on medium-sized projects of moderate complexity under limited supervision. Your role initiates and shapes research programs in collaboration with the Medical Office, external clinical, academic and other partners for Heart Rhythm Management products.
Your role:
Contributes to the strategic guidance for clinical and economic evidence related to the end to end (E2E) development process from ideation through post-market for products in heart rhythm management. Collaborates with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product life cycle management.Drives execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, be agile and responsive during course of design, execution, and interpretation of trial data. Collaborates with, investigators, IRB’s/EC’s, Regulatory Agencies, societies and associations; and additionally, to support claims, reimbursement, health economic outcomes and/or market access.Participates in clinical evaluation documentation including guidance on PMCF initiatives and clinical investigation documents in accordance with applicable regulatory standards.Ensures appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned.Leads or supports scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, including during sponsor regulatory inspections.You're the right fit if:
You’ve acquired 7+ years scientific/research background with experience in clinical research with a working knowledge of GCP, FDA regulations and EU-MDR regulations.Your skills include product development and associated design controls for medical devices; strong ability to collaborate effectively and influence decision making with various teams, cross-functional team members as well as external partners.You have a Bachelor’s Degree, required; PhD or MD preferred with a background in medical device design and/or HRM procedures will substitute for 2 years of experience, preferred. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You also should possess strong writing skills to produce quality clinical documents, including final reports; analytical thinking, able to present statistical methods and results to a variety of audiences, especially non-statisticians. Must be able/willing to travel around 25% of the time.How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business.Discover our rich and exciting history.Learn more about our purpose.Learn more about our commitment to diversity and inclusion.Philips Transparency Details
The pay range for this position in Plymouth, MN is $129,375 to $207,000.
The pay range for this position in Cambridge, MA is $144,900 to $231,840.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
You must reside in, be within commuting distance or be willing to relocate to Plymouth, MN OR Cambridge, MA.
#LI-PH
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.