Senior Clinical Scientist, Rare Disease

The Role

This role will support early/late phase Rare Disease Therapies specifically supporting the Study Physician/s executing phase 1-3 studies. As part of the role, the Clinical Scientist will:

• Support the Study Physician/s and cross-functional study management teams in the oversight of clinical studies including review and interpretation of clinical trial data and timely execution of deliverables in collaboration with relevant internal and external partners.

• Support the Study Physician, the Clinical Scientist assists in the preparation of protocol writing, informed consents, and other protocol-related documents for the operational execution of clinical studies.

• Participate in the start-up of global clinical studies, working with Clinical Operations to ensure on schedule site activation and subject enrollment, monitoring, compliance with department safety practices, policies, procedures as well as the day-to-day management of a clinical trial Implement clinical study parameters, deliverables, policy compliance and resource needs, apply scientific discipline to minimize risk and increase performance.

• Plays a key role in the driving the review of study data to ensure timely and high-quality data entry, including review of case report forms, assists in coding, analysis, and proper and complete documentation of clinical data.

• Participate in investigator meetings, investigator engagement, including assisting in the preparation of Advisory Board meetings

• Supports regulatory activities as required

• Supports Study Physician and Pharmacovigilance in managing sites to ensure study treatment discontinuation or other safety decisions are made per protocol and align with stakeholders within the study team.

• Supports the Study Physician to coordinate relevant and timely data analyses and presentations in collaboration with safety, data management, Data Monitoring Committee, Biostatistics, Pharmacometrics and Biomarker teams to meet timelines for safety monitoring committee meetings, regulatory documents and to internal reviews to make timely program decisions regarding study objectives.

• Participate in the training of site and Company staff on the study protocol, ensure the clinical staff have the necessary guidance and tools for performance of various projects

• Conduct literature reviews as needed

Here’s What You’ll Bring to the Table:

• High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to early disease clinical research and the highest personal and ethical standards. 

• Must be equally comfortable among the team to which he/she is assigned and in the global environment in which the Company operates.

• Require capabilities to work on additional studies moving into operation in later years. This will involve close interaction and working closely with the discovery, biomarkers, clinical pharmacology, pharmacometrics, regulatory, biostatistics, clinical operations, and Clinical Development. 

• Understanding how these various functions work, the Clinical Scientist should be capable of implementing translational medicine approaches for clinical development. 

Qualifications

• Advanced Degree in a Scientific discipline (i.e. M.S, Ph.D. or Pharm.D. or equivalent work experience) is required.

• A minimum of 5 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is preferred.

• Experience Rare Disease development.

• Significant experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.

• Significant experience with biostatistics, GCP, data integrity, exploration, analysis, regulatory requirements for clinical studies and presentation

• Ability to handle multiple projects simultaneously

• Excellent written communication, oral communication, and presentation skills are required.

• The individual must have demonstrated ability to work in a team environment.

• Ability to travel up to 15% required.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, n