PhilipsSenior Clinical Development Scientist
Job Title
Senior Clinical Development Scientist
Job Description
The Senior Clinical Development Scientist is responsible for analyzing clinical trial protocols and studies to ensure regulatory compliance and strategic alignment, working independently. The role collaborates with multidisciplinary teams to develop robust clinical development and market access strategies for New Product Introduction (NPI) projects and post-market initiatives, integrating inputs from various stakeholders. The role crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and regulatory submissions. The role troubleshoots complex issues in clinical data collection, analysis, and reporting, ensuring data integrity and accuracy and contributes to scientific knowledge by critically analyzing study data and disseminating findings through publications and presentations.
Job Responsibilities:• Analyzes clinical trial protocols and studies, ensuring adherence to regulatory requirements and alignment with strategic objectives, providing recommendations for protocol optimization and enhancement, working independently.• Collaborates with multidisciplinary teams to develop robust clinical development and market access strategies for New Product Introduction (NPI) projects and post-market initiatives, integrating inputs from stakeholders such as Marketing/BU Claims, regional/market needs, Health Economics, Market Access, and Post Market Surveillance (PMS).• Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing expert-level proficiency in standard software tools and systems, adhering to internal procedures, templates, and external standards, regulations, and guidance.• Troubleshoots complex issues related to clinical data collection, analysis, and reporting, leveraging advanced analytical skills to ensure data integrity, accuracy, and consistency across studies.• Assesses and critically analyzes clinical study data within the clinical study report, synthesizing findings to support dissemination efforts such as abstracts, white papers, and peer-reviewed publications, contributing to the advancement of scientific knowledge.• Communicates effectively with internal and external stakeholders, ensuring clarity and alignment on project objectives, milestones, and timelines, facilitating informed decision-making and fostering collaborative relationships.• Facilitates interactions with colleagues to determine and implement optimal approaches for evidence generation and clinical study design, fostering a culture of innovation and excellence within the clinical development team.• Presents findings from literature reviews and data analyses to internal stakeholders, contributing to informed decision-making processes and strategic discussions.• Builds relationships with Key Opinion Leaders (KOLs) and Investigators, facilitating the execution of clinical studies and ensuring robust data generation, contributing to the credibility and success of clinical development programs.• Disseminates evidence derived from clinical studies, effectively communicating the impact and significance of findings to internal teams and external stakeholders, contributing to the broader scientific community and market understanding.• Facilitates ongoing collaboration and interaction between internal teams, fostering a culture of cross-functional teamwork and knowledge sharing to drive project success.
Minimum required Education:Bachelor's/ Master's Degree in Life Science or equivalent.
Minimum required Experience:- Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Clinical Research, MedTech, Healthcare Administration or equivalent.
- Good communication both in English & Chinese
- Proactive
Preferred Education:MD/PhD or equivalent.
Preferred Experience:5-8 years of experience with Bachelor's or 4-7 years of experience with Master's in areas such as clinical research or equivalent.Experience in MedTech and understanding of Health Care Administration or equivalent.2+ years of experience in leading teams or demonstrated subject matter expert in technology/therapeutic domain expertise or equivalent.
Preferred Skills:• Regulatory Compliance• Data Analysis & Interpretation• Continuous Improvement• Business Acumen• Project Management• Strategic Planning• KPI Management• Document Auditing• Medical Terminology• Medical Writing• Regulatory Requirements• Clinical Evaluation Methodologies• Clinical Evidence Generation Strategy• Report Writing
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 the lives of others.• Learn more about our business.• Discover our rich and exciting history.• Learn more about our purpose.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 culture of impact with care here.