Senior Clinical Scientist

Senior Clinical Scientist

Department: Clinical Development

Employment Type: Full Time

Location: Cambridge, MA

Description

We are seeking a highly skilled and motivated Senior Clinical Scientist to join our team and contribute to the development and execution of global Phase 1-3 clinical studies.

The Role:

In this role, you will be responsible for leading and overseeing critical aspects of clinical trial development and execution.
Key Responsibilities:

• Lead the scientific planning and execution of clinical trials, ensuring high-quality data collection and analysis.
• Serve as the lead clinical scientist on clinical trial teams, collaborating with cross-functional teams to develop protocols, study materials, and investigator brochures.
• Provide medical and scientific guidance during study execution, including medical monitoring, data review, and protocol deviation analysis.
• Collaborate on safety reporting, including SAE reconciliation, safety review meetings, and regulatory submissions.
• Participate in the development of clinical study reports, ensuring data integrity for publications and presentations.
• Mentor and coach other clinical scientists, fostering team capabilities.

Other Responsibilities:Protocol and Study Design:

• Provide medical/protocol training for site-facing roles.
• Develop clinical sections of the Site Reference Manual.
• Create and review informed consent form (ICF) templates.
• Support the preparation of clinical documents.

Data Review and Interpretation:

• Provide clinical input for study setup, data analysis, and database configuration.
• Review patient/study data and ensure accurate reporting of protocol deviations.
• Participate in study analysis, including interim analyses and safety board management.
• Prepare and moderate medical data review plans.

Study Medical Oversight:

• Collaborate with study physicians for medical/scientific guidance.
• Assist in monitoring plan development and issue resolution.
• Provide input during vendor selection for medical/protocol issues.

Safety Management:

• Oversee and track safety reconciliation across studies.
• Report Serious Adverse Events (SAEs) in Safety Review Team meetings.
• Review and approve patient narratives, CIOMS forms, and Drug Safety Update Reports (DSURs).
• Collaborate on post-marketing commitments and ensure timely submissions.

Regulatory and Publications:

• Lead clinical preparations for regulatory submissions and advisory meetings.
• Review and edit clinical study reports (CSRs) and ensure data cleanliness for publications.
• Prepare audit responses and participate in inspection readiness activities.

Clinical Program Implementation:

• Contribute to the development of clinical development plans and target product profiles.
• Ensure regulatory compliance and GCP adherence at the study level.
• Coordinate with Clinical Operations to resolve study-level issues and maintain timelines.
• Participate in the development and training of study management staff.
• Represent Clinical Development in global process improvement initiatives.

Your Profile

The successful Clinical Scientist works well in cross-functional teams and is an excellent communicator. This will be backed up by the following:

• Bachelor's degree with 15+ years, Master's degree with 12+ years, or PhD/PharmD with relevant experience in pharmaceutical clinical drug development or the medical field.
• Strong knowledge of clinical research regulatory requirements (GCP, ICH).
• Proven ability to manage multiple priorities with strong analytical, leadership, and problem-solving skills.
• Oncology experience and a degree in life sciences are preferred.
• Experience in both early and late-phase clinical studies is highly desirable.

Why Merus?

At Merus, we are committed to creating a dynamic and supportive environment where innovation thrives. As a senior leader, you will play a key role in shaping the future of our company, ensuring the safety of our patients and driving our mission forward. Join us and be part of a team that is making a difference in the lives of patients worldwide.