Job Description

The Role:

Moderna is seeking an experienced Clinical Sciences Team Leader to build and expand its clinical science capabilities. This role requires a strong track record of successfully building business capabilities in the biotech or pharmaceutical industry, advanced scientific and line function/team leadership skills, and a deep commitment to transforming patients' lives.

Here's What You'll Do:

* Establish Clinical Sciences as a valued scientific leadership line function

* Hire, onboard, train, mentor, develop, and manage a high-functioning group of clinical scientists that are seen as valued scientific partners in the design and execution of clinical programs

* Partner with critical Functional Line Leaders (Study Physicians, Clinical Operations, Biometrics, Safety) to define cross-functional ways of working with Clinical Sciences

* Setup ways of working, standards, and tools for Clinical Scientists to ensure clinical relevancy and interpretability of data through the authorship of core study documents (e.g., protocols, informed consent forms, eCRFs) and the creation & execution of critical study plans (e.g., medical monitoring and data cleaning plans)

* Serve as point of contact and escalation for setting up and managing outsourced scopes of work to Contract Research Organizations through partnership with Development Operations

* Serve as the accountable person for the quality of clinical trial data for clinical review and interpretation to achieve regulatory reporting/filing milestones

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* Partner across development line functions to deliver well executed clinical programs

* Partner with Program and Clinical Leadership to plan and resource clinical programs effectively

* Oversee the quality and effectiveness of the Clinical Scientist Team, including their:

* Collaboration with Clinical Operations, Study Team & Program Leadership in the planning and execution of clinical studies

* Effective Scientific Authorship of protocols, consent forms, analysis plans and other key scientific study documents

* Timely and High-Quality Data Review of data listings, data coding, cohort profiles, and analyses

* Coordination of clinical and safety oversight by Study Physicians and Pharmacovigilance to ensure study treatment discontinuation or other safety decisions are made per protocol

* Oversight of database

* Delivery of Relevant and Timely Data Analyses, Reporting & Presentation to meet timelines for investigator & monitoring committee meetings, regulatory actions, and to make timely program decisions regarding study objectives

* Planning and Execution of Protocol/Scientific Training of Investigators, Site Management/Monitors, and other key study personnel

* Facilitation of scientific content and discussion for Advisory Board / Scientific Committee Meetings, and with Investigators and Site Study Staff throughout the lifecycle of the program

* Serve as a Clinical Scientist to address study demands as needed, acting as player coach, taking on study level responsibility as needed

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

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

* A minimum of 10 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required

* The individual must have demon
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