As a Clinical Development Lead on the Hospital Patient Monitoring (HPM) Clinical Affairs team, you will primarily focus on designing and supporting the execution of proactive/specific Post Market Clinical Follow-up (PMCF) activities, for HPM’s portfolio of medical devices.Your role:
Leading the design of clinical activities for proactive PMCF, including retrospective and prospective data collection methodologies. Defining clinical questions, study endpoints, contributing to statistical methodologies to validate study objectives, identifying relevant evidence and critically apprising evidence.
Liaising with other functions to enable quality clinical study execution as the study design subject matter expert. Serving as internal Principal Investigator on Philips sponsored studies where needed.
Supporting input to Post-Market Clinical Follow-up Plans based on clinical evidence gaps identified in Clinical Evaluation Reports and based on proactive PMCF activities.
Acquiring or possessing in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature. Contributing to authoring of manuscripts, conference presentations, and other dissemination activities.
Complying with Good Documentation Practices to ensure quality and accuracy of document content and format. Ensuring compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines).
You're the right fit if:
You’ve acquired 4+ years of experience in the design and execution of clinical studies for medical devices, including retrospective and prospective designs, multi-site clinical investigations, survey research, and/or registries. You have knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation, and experience performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.)
Your skills include experience designing proactive PMCF activities and/or designing studies that collect real world data (preferred).
You have an advanced scientific degree (M.S., MPH, Ph.D., or similar degree) in the health sciences, life sciences, clinical sciences, biomedical engineering, or similar/related discipline/field. A health professions background is a plus.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
You’re an excellent communicator (both written and verbal), have strong attention to detail and have demonstrated the ability to work in a team environment, including leading discussions and presenting to internal business and regulatory stakeholders. Also, you have strong Project/timeline management and organizational skills.
About PhilipsWe 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.
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Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
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Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency DetailsThe pay range for this position is $74,680 to $150,931, annually. The actual base pay offered may vary 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 (https://www.careers.philips.com/na/en/best-employee-benefits) .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 InformationUS 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.Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Murrysville, PA, Nashville, TN, Plymouth, MN, Cambridge, MA, Pittsburgh, PA .#LI-PH1It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran
