Senior Clinical Scientist

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Assist in the development and formulation of clinical trial protocols that adhere to high scientific and clinical standards, as well as applicable regulations.

• Aid in the identification, formulation, and execution of amendments to the clinical protocol, working closely with the clinical lead.

• Help create study-level documents, including the preparation of clinical sections for key regulatory documents such as Investigator’s Brochures, briefing books, safety updates, and submission dossiers.

• Support the review and writing of clinical trial documents for CTR activities, and publications when applicable.

• Assist with pharmacovigilance activities, including the creation and review of aggregate reports, patient narratives, and participation in pharmacovigilance monitoring meetings.

• Provide support for regulatory activities, including the preparation of meetings with regulatory agencies.

• Develop training materials, share best practices, and deliver training to the wider clinical trial teams.

• Assist in the preparation and, if necessary, participate in study-level meetings (e.g., Investigator Meetings, Data Monitoring meetings, and others).

• Support and guide the establishment of data review strategies, ensuring consistent implementation of protocol-level deviations, eligibility criteria, study assessments, and other protocol aspects across the study (across countries/sites).

• Include support for Case Report Form (CRF) development and implementation of data capture tools.

• Utilize deep expertise to conduct thorough and high-quality clinical data reviews, identifying clinical data insights through ongoing patient-level reviews and trend analysis to facilitate Interim Analysis, Database, and Post Lock activities, as well as resolution of scientific and medical issues throughout the study lifecycle.

• Strive to enhance the quality of reviews and insights with a focus on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and the identification of cases for medical review.

• Provide insights and improve the data review process by identifying redundant reports, implementing innovative data analysis processes and tools, and ensuring their continuous enhancement.

• Collaborate closely and align with the clinical development lead for all tasks.

• Ensure that all questions or issues requiring medical oversight are communicated to the clinical development lead.

⛳️ Requirements

• Advanced degree in life sciences, healthcare, or a clinically relevant field.

• At least 8 years of experience as a Clinical Scientist with expertise in the Oncology therapeutic area, preferably within a Phase 1b/2 clinical research environment.

• Strong working knowledge of Good Clinical Practice (GCP) and drug development processes.

• Preferred experience in the setup, organization, and execution of global clinical studies within a pharmaceutical company or contract research organization (CRO) environment.

• Solid understanding of clinical data collection and reporting principles, with a proven ability to utilize typical systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis, and reporting.

• Demonstrated ability to drive continuous improvement in processes, systems, and tools.

• Experience working in a matrix environment, with a strong capacity to informally influence and collaborate without formal authority.

• High flexibility and an adaptive working style, with the ability to manage multiple tasks simultaneously.

• Capability to work effectively under significant time pressure while maintaining high-quality standards.

• Proficiency in prioritizing tasks and implementing accordingly.

• High proficiency in English, both written and spoken.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.