Clinical Development Scientist

inSync Staffing
US - Washington - Bothell
November 15, 2024
Science

Title: Clinical Development Scientist

Pay: $100.00

Hours: Monday-Friday, 8AM-5PM, Hybrid (3 days in office)

Location: Hybrid Bothell, WA 98021 or Cambridge, MA 02141

Overview

The Clinical Development Scientist leads the development and execution of evidence generation strategies for assigned clinical projects, working within a cross-functional team. The role focuses on creating Clinical Development Plans, conducting studies, and delivering data-driven insights to support regulatory submissions, market access, and compliance with global regulatory standards.

Clinical Evidence Strategy: Lead the creation of evidence generation strategies that align with the value proposition and address the needs of all key stakeholders.

Study Development: Develop Clinical Development Plans and study protocols that comply with regulatory guidelines (GCP, FDA, ISO, EU MDR) and oversee study execution and result analysis.

Collaboration: Work closely with internal (project owners, regulatory, statisticians, etc.) and external stakeholders (clinical consultants, KOLs) to ensure studies meet high standards and yield actionable data.

Clinical Program Delivery: Oversee clinical program delivery in collaboration with Clinical Operations, ensuring efficient and compliant project execution.

Evidence Dissemination: Lead clinical evaluation reporting, deliver Clinical Evaluation Reports and Clinical Study Reports, and publish results in peer-reviewed journals.

Regulatory Engagement: Manage interactions with regulatory bodies, addressing queries and participating in discussions regarding clinical evidence and surveillance.

Medical Safety Support: Collaborate with Medical Safety to support signal detection and evaluation processes.

Data Network Strategy: Support data infrastructure initiatives, including data partnerships, data dictionary creation, and assessment of real-world data vendors.

Data Governance: Assist the Data Governance Council with deidentification and data use standards to enhance data governance.

Required Skills

Scientific Background: Strong foundation in biomedical sciences, epidemiology, or related field, with a deep understanding of clinical evaluation, RWE, and research methodologies.

Regulatory Knowledge: Comprehensive knowledge of global regulatory standards, including GCP, FDA, EU MDR, and ISO regulations.

Machine Learning Expertise: Experience with machine learning and AI algorithm clinical validation.

Data Analysis: Proficient in designing innovative clinical trials, registries, and quality improvement projects, with familiarity in biostatistics.

Communication: Strong written and oral communication skills with experience in scientific documentation, peer-reviewed publications, and presenting research.

Leadership: Ability to lead and shape clinical initiatives in a cross-functional team without direct reporting authority.

Education & Experience Requirements

Degree: MD, PhD, or MS in Biomedical Science, Epidemiology, or related field preferred.

Experience: 7+ years in clinical research, development, or real-world evidence roles (medical device experience preferred).

Track Record: Demonstrated success in developing and executing clinical evidence strategies for regulatory submissions and compliance with SOPs and regulations.

Benefits (employee contribution):

Health insurance

Health savings account

Dental Insurance

Vision Insurance

Flexible spending accounts

Life insurance

Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Read the full job description and apply online on the recuiter's web-site

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