Senior Clinical Scientist
Apply NowCompany: Merus
Location: Cambridge, MA 02139
Description:
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:
Other Responsibilities:Protocol and Study Design:
Data Review and Interpretation:
Study Medical Oversight:
Safety Management:
Regulatory and Publications:
Clinical Program Implementation:
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:
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.
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.