Clinical Development Scientist, Computed Tomography
philips · Malvern
Job description
About the role
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 Clinical Evaluation Reports, Clinical Study Reports, regulatory submissions, and scientific publications. The role also advances clinical development and market‑access strategies by generating evidence‑based insights, cultivating key‑opinion‑leader relationships, and supporting innovative study designs.
Key responsibilities
- 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 to support regulatory submissions.
- Collaborate with internal and external partners—including project owners, regulatory teams, statisticians, clinical consultants and regulatory agencies—to ensure comprehensive analysis of clinical evidence.
- Interpret and disseminate evidence, including authoring Clinical Study Reports, CERs, PMCF reports and supporting timely publication of study results.
- Create procedures and workflows for the Clinical Development department.
Required profile
- 2+ years of experience in Clinical Affairs, Clinical Research or a similar role within the medical‑device, pharmaceutical or healthcare industry, with a proven record of delivering results on time, within budget and in compliance with SOPs and regulations.
- Strong knowledge of EU Medical Device Regulations, Good Clinical Practice (GCP) and ICH guidelines, plus experience with clinical investigation design, biostatistics, research methodologies, literature databases and medical writing.
- Advanced degree (MSc, PhD, MD or PharmD) in biomedical sciences, life sciences, public health or a related discipline; experience authoring MEDDEV 2.7.1 Rev. 4 and MDR‑compliant CERs and PMCF documentation is a plus.
- Detail‑oriented, highly organized professional with excellent analytical, communication and project‑management skills, able to collaborate with cross‑functional global teams and communicate fluently in English.
Required skills
- EU Medical Device Regulations
- Good Clinical Practice (GCP)
- ICH guidelines
- Clinical investigation design
- Biostatistics
- Research methodologies
- Medical and scientific literature databases
- Medical writing
- Statistical methods
- Statistical software
What we offer
- Base salary range $107,000 – $170,000 (Malvern, PA) with potential annual incentive bonus and long‑term incentives.
- Comprehensive Philips Total Rewards benefits including generous PTO, 401(k) plan with up to 7 % match, HSA contributions, stock purchase plan and education reimbursement.
- Office‑based role with hybrid work model (minimum three days on‑site per week).
- Opportunity to work for a global health‑technology leader focused on improving access to quality healthcare.
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Published 1 day ago
Expires 1 month from now
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philips
Malvern
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