Senior Scientist, Clinical Research

Job Description

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 oversees trials within and across therapeutic areas, ensuring clinical trial excellence, compliance and data validity. The position manages team performance to achieve project objectives and resolves performance issues when they arise.

Key responsibilities include safe risk assessment, real‑time oversight of ongoing trials to identify and mitigate patient, study design, data or conduct issues, and performing on‑site site monitoring and training for complex biomarker collection. The ECS applies in‑depth knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.

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 and develop study operational documents such as site monitoring plans, operations manuals and informed consent.

Manage trial and program projects, including team activities (meetings, document and workspace management), risk assessment and contingency planning under accelerated timelines. Build knowledge of early drug development processes to manage additional procedures.

Education Minimum Requirement:

• Degree in Life Sciences
• Bachelor’s degree and at least 6 years related experience, or
• Master’s degree and at least 4 years related experience, or
• PhD or doctorate and at least 2 years related experience

Related experience may include clinical trial management, site training/monitoring, and medical and regulatory writing.

Required

Experience and Skills:

• Minimum 3 years 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
• Rapid acquisition of scientific knowledge across therapeutic areas
• Ability to manage complex operations and projects under accelerated timelines
• Scientific, medical and/or safety writing and reporting (at least one required)
• Effective partnership 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

Preferred

Experience and Skills:

• Experience with global Phase I subject and patient trials, safety reporting and regulatory WMA submission is a plus
• Experience managing Immunology and/or vaccine trials, with the ability to explore novel approaches and navigate ambiguity is a plus

Required Skills:

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

Preferred

Skills:

Current Employees Apply HERE – Current Contingent Workers Apply HERE

US and Puerto Rico Residents Only: The company is committed to inclusion and provides accommodations during the application or hiring process.  if you need an accommodation.

The company is an Equal Employment Opportunity Employer that prohibits discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or other legally protected characteristics. As a federal contractor, it complies with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC resources and the company’s website.

The salary range for this role is $ – $. The employee’s position within the range will be based on education, qualifications, certifications, experience, skills, location, government requirements and business needs.

The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. The company offers a comprehensive benefits package, including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days. More information about benefits is available on the company website.

Job Posting End Date: 07/7/2026 (apply before this date).