Clinical Development Scientist, Computed Tomography

Clinical Development Scientist CT

The Clinical Development Scientist for our Computed Tomography business analyzes clinical studies and protocols to ensure regulatory compliance data integrity and strategic alignment while developing high-quality CERs CSRs regulatory submissions and scientific publications. The role also advances clinical development and market access strategies by generating evidence-based insights cultivating KOL relationships and supporting innovative clinical study designs.

Your role:

• Collect appraise and analyze clinical data pertaining to a medical device.
• Write documentation such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Reports supporting regulatory submission.
• Collaborate with internal (project owners regulatory study managers statisticians business leaders post-market surveillance risk management etc.) and external (clinical consultants subject matter experts regulatory agencies) partners to ensure comprehensive analysis of clinical evidence.
• Ensure appropriate interpretation and dissemination of all evidence generated including writing Clinical Study Reports (CSRs) Clinical Evaluation Reports (CERs) Post-Market Clinical Follow-Up (PMCF) Reports and supporting the timely publication of study results.
• Create procedures and workflows related to the Clinical Development department.

Youre the right fit if:

• You have acquired 2 years of experience in Clinical Affairs Clinical Research or a similar role within the Medical Device Pharmaceutical or Healthcare industry with a proven track record of delivering clinical results on time within budget and in compliance with SOPs and regulatory requirements.
• You have a strong understanding of EU Medical Device Regulations Good Clinical Practice (GCP) and ICH guidelines; experience with clinical investigation design biostatistics research methodologies medical and scientific literature databases and medical writing. Experience applying statistical methods to clinical data and proficiency with statistical software are preferred.
• You have an MSc Ph.D. M.D. or Pharm.D. in Biomedical Sciences Life Sciences Public Health or a related healthcare discipline. Experience authoring MEDDEV 2.7.1 Rev. 4 and MDR-compliant Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) documentation is a strong plus.
• You are a detail-oriented and highly organized professional with excellent analytical communication and project management skills. You can effectively collaborate with cross-functional and global teams manage multiple priorities in a fast-paced environment and communicate fluently in English; additional language proficiency is an advantage.
• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.

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 companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.

This is an office-based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters and we wont 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 culture.

Philips Transparency Details

The pay range for this position in Orange OH is $102000 to $162000.

The pay range for this position in Malvern PA is $107000 to $170000.

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.

Company relocation benefits will not be provided for this position. For this position you must reside in or within commuting distance to Malvern PA or Orange OH.

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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 including Disability/Vets and maintains a drug-free workplace.