Senior Scientist, Clinical Research

• The Early Clinical Scientist (ECS) coordinates the design, planning and execution of early phase clinical trials with the Clinical Director, and internal/external team members.
• Oversees trials within and/or across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity.
• Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise.
• Ensures appropriate clinical safety assessment and risk management of compounds.
• Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues.
• Reviews and interprets clinical trial data.
• May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes.
• Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• Represents Early Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures.
• Identifies and communicates best practices within the organization.
• Promotes departmental adaptation of new procedures.
• Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts.
• Ensures documents are completed in accordance with applicable standards.
• Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.).
• Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.

• At least 3 years experience in an operational clinical scientist or study manager role in clinical research at a pharmaceutical or biotech company.
• Understanding of clinical research development process from program planning to regulatory submission
• Able to quickly develop a working scientific knowledge of different therapeutic areas
• Ability to manage complex operations and projects under accelerated timelines
• Scientific, medical and/or safety writing and reporting (at least one is required)
• Ability to partner effectively with internal and external teams to achieve results
• Knowledge of GCP, ICH guidelines and regulatory requirements

Demonstrates expertise in managing early phase clinical trials, ensuring compliance with GCP and ICH guidelines, and effectively collaborating with cross-functional teams to achieve project objectives. Proficient in scientific writing and regulatory submissions, with a strong ability to assess clinical safety and manage complex operations under tight timelines.

• Clinical Trial Management
• GCP Compliance
• ICH Guidelines Knowledge
• Scientific Writing
• Cross-Functional Collaboration

• Clinical Trial Design
• Data Interpretation
• Risk Management
• Study Monitoring
• Operational Document Development

• Team Management
• Problem Solving
• Effective Communication

• Clinical Research
• Pharmaceutical
• Biotech
• Regulatory Submission
• Therapeutic Areas