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, ensuring excellence in execution and compliance to support study objectives and data validity. Manages internal/external team performance to achieve project objectives and resolves project performance issues. 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 and 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, SOPs, and clinical development procedures. Identifies and communicates best practices within the organization and promotes departmental adaptation of new procedures.

Responsibilities

• Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, regulatory agency update and safety reports, 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).
• Manages trial and program projects, including team activities (meetings, document/collaborative workspace management), provides risk assessment and contingency planning under accelerated timelines.
• Conducts real-time oversight of ongoing trials to identify and mitigate issues related to patient safety, study design, data integrity, or study conduct.
• Applies knowledge of early drug development processes and builds skills to manage additional processes/procedures effectively.

Requirements

• 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 (e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing).
• At least 3 years of experience in an operational clinical scientist or study manager role in clinical research at a pharmaceutical or biotech company.
• Understanding of the clinical research development process from program planning to regulatory submission.
• Ability 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.
• Strong team collaboration, leadership, communication (written and verbal), issue identification, and resolution skills.
• Knowledge of GCP, ICH guidelines, and regulatory requirements.

Preferred Qualifications

• Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience.
• Experience managing Immunology and/or vaccine trials with an ability to think outside the box, explore novel ways of working, and navigate ambiguity to drive results.

Skills

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

Pay

The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• Medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at Merck Compensation and Benefits.

Schedule

• 10% travel requirements.
• Flexible work arrangements: Hybrid.