Senior Scientist, Clinical Research

About the role

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.

Responsibilities

• 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.
• Technical Writing & Communications:
  • 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.).
• Project Management:
  • 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.
  • Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.

Requirements

• Minimum Requirement: Degree in Life Sciences Bachelor’s degree and ≥6 years related* experience, OR Master’s degree and ≥4 years related* experience, OR PhD or doctorate with ≥2 years related* experience.
• Required Experience: 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).
• Able to partner effectively with internal and external teams to achieve results.
• Strong team collaboration, leadership, communication (written & verbal), issue identification and resolution skills.
• Knowledge of GCP, ICH guidelines and regulatory requirements.

Qualifications

• Education: Minimum Requirement: Degree in Life Sciences Bachelor’s degree and ≥6 years related* experience, OR Master’s degree and ≥4 years related* experience, OR PhD or doctorate with ≥2 years related* experience.
• Experience: At least 3 years experience in an operational clinical scientist or study manager role in clinical research at a pharmaceutical or biotech company.
• Skills: 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); Able to partner effectively with internal and external teams to achieve results; Strong team collaboration, leadership, communication (written & verbal), issue identification and resolution skills; Knowledge of GCP, ICH guidelines and regulatory requirements.

Skills

• Adaptability.
• Biopharmaceutical Industry.
• Clinical Development.
• Clinical Research.
• Clinical Study Management.
• Clinical Trials.
• Clinical Trials Analysis.
• Drug Development.
• Ethical Compliance.
• Ethical Standards.
• ICH GCP Guidelines.
• Immunology.
• Medical Writing.
• Multiple Therapeutic Areas.
• Phase I Studies.
• Project Management.
• Protocol Development.
• Regulatory Requirements.
• Regulatory Submissions.
• Regulatory Writing.
• Risk Assessments.
• Scientific Publications.
• Technical Writing.

Benefits

• Medical.
• Dental.
• Vision Healthcare.
• Retirement Benefits, including 401(k).
• Paid Holidays.
• Vacation.
• Caregiving and Sick Leave.