Senior Clinical Development Scientist

13 Minutes ago • All levels

Data Analysis

Job Description

This role involves analyzing clinical trial protocols, crafting comprehensive clinical reports (CERs, CSRs), troubleshooting data issues, and synthesizing findings for dissemination. The Senior Clinical Development Scientist will also develop clinical development and market access strategies, conduct literature reviews for NPI and LCM, support KOL relationships, and present findings to stakeholders, ensuring regulatory compliance and strategic alignment.

Good To Have:

2-5 years of experience in clinical research or equivalent.
Experience in MedTech and understanding of Health Care Administration or equivalent.
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

Must Have:

Analyzes clinical trial protocols and studies, ensuring adherence to regulatory requirements and alignment with strategic objectives.
Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions.
Troubleshoots complex issues related to clinical data collection, analysis, and reporting.
Assesses and critically analyzes clinical study data within the clinical study report.
Develops Clinical Development and Market Access strategies and contributes to the development of clinical protocols.
Performs comprehensive literature searches and in-depth reviews to support evidence-generation processes.
Minimum 2 years of experience with Bachelor's in Clinical Research, MedTech, Healthcare Administration or equivalent OR no prior experience required with Master's Degree.

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Job Title

Senior Clinical Development Scientist

Job Description

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.

• Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing advanced-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 analytical skills to ensure data integrity, accuracy, and consistency across studies, working under some supervision.

• 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.

• Develops Clinical Development and Market Access strategies, referencing applicable business processes, and contributes to the development of clinical protocols in accordance with relevant standards and regulations, ensuring strategic alignment and regulatory compliance.

• Performs comprehensive literature searches and in-depth reviews to support evidence-generation processes for both New Product Introduction (NPI) and Life Cycle Management (LCM) initiatives, providing critical insights and evidence-based support for decision-making.

• Supports 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.

• Interacts closely with colleagues to determine and implement optimal approaches for evidence generation and clinical study design, promoting 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.

• 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.

Minimum required Education:

Bachelor's/ Master's Degree in Life Science or equivalent.

Minimum required Experience:

Minimum 2 years of experience with Bachelor's in areas such as Clinical Research, MedTech, Healthcare Administration or equivalent OR no prior experience required with Master's Degree.

Minimum required Certification:

N/A

Preferred Education:

N/A

Preferred Experience:

2-5 years of experience in areas such as clinical research or equivalent. Experience in MedTech and understanding of Health Care Administration or equivalent.

Preferred Certification:

N/A

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 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 the lives of others.

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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

About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

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To ensure reasonable accommodations 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.

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