Senior Scientist, Clinical Research

Overview

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. The ECS ensures excellence in execution and compliance to support study objectives and data validity, manages team performance, and resolves performance issues.

Responsibilities

• Oversee trials within and/or across therapeutic areas.
• Ensure appropriate clinical safety assessment and risk management of compounds.
• Conduct real‑time oversight of ongoing trials to identify and mitigate patient, study design, data, or conduct issues.
• Review and interpret clinical trial data.
• Conduct on‑site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes.
• Apply thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• Represent Early Stage Development on cross‑functional teams to develop and improve internal job aids, SOPs, and clinical development procedures; identify and communicate best practices; promote departmental adaptation of new procedures.
• Co‑author clinical sections of protocols, investigator brochures, study reports, WMA/CTD subsections, safety reports, development plans, publications, and abstracts; ensure documents meet applicable standards.
• Develop study operational documents (e.g., site monitoring plan, operations manual, informed consent).
• Manage trial and program projects, including meetings, document and workspace management, risk assessment, and contingency planning under accelerated timelines.

Qualifications

• At least 3 years of experience in an operational clinical scientist or study manager role in a pharmaceutical or biotech company.
• Understanding of the clinical research development process from program planning to regulatory submission.
• Ability to quickly acquire scientific knowledge across therapeutic areas.
• Experience managing complex operations and projects under accelerated timelines.
• Scientific, medical, and/or safety writing and reporting experience.
• Strong team collaboration, leadership, communication, issue identification, and resolution skills.
• Knowledge of GCP, ICH guidelines, and regulatory requirements.

Preferred Experience and Skills

• Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience.
• Experience managing Immunology and/or vaccine trials, and ability to navigate ambiguity.

Education

• Degree in Life Sciences with at least 6 years related experience, or
• Master's degree with at least 4 years related experience, or
• PhD or doctorate with at least 2 years related experience.

Benefits

Comprehensive benefits package including medical, dental, vision, retirement, paid holidays, vacation, and sick days. Annual bonus and long‑term incentive as applicable.

Salary

Salary range: $117,000.00 – $184,200.00.

EEO Statement

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement.