The RoleModerna is seeking an experienced clinical drug leader to build, expand and lead its clinical science capabilities across all of Development at Moderna. This role requires a strong track record of successfully developing biologics from pre-clinical through BLA; a deep understanding of all components of clinical drug development; superb ability to interrogate clinical data and identify signals and patterns; line function/team leadership skills, and a deep commitment to transforming patients' lives.
Here's What You'll Do- Establish Clinical Sciences as a critical scientific 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, execution and interpretation of all Moderna clinical programs across the pipeline
- Partner with critical Functional Line Leaders (Study Physicians, Clinical Operations, Data management, Translational medicine, Biometrics, Safety) to define cross-functional ways of working with Clinical Sciences and ensure trials are designed to meet defined Go/No Go criteria, and data generated and interpreted for external presentation, regulatory reporting/filing milestones
- Establish best practices for design of clinical protocols, activate clinical trials, review and interrogate clinical data as it emerges, summarize and interpret data
- 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
- 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, eCRFs, analysis plans and other key scientific study documents
- Timely and High-Quality Data Review and Interpretation 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
- When necessary, act as player coach, taking on study level responsibility as needed
- Ownership of strategy for how clinical data at Moderna is reviewed and analyzed
- Establish practices for best-in-class, real time review of emerging clinical data
- Ensure protocols are written effectively and efficiently to reduce unneeded amendments
- Budget ownership for all software for medical monitoring
Here's What You'll Need (Basic Qualifications)- Doctoral degree in a scientific, medical, or related discipline, such as a PhD, MD, PharmD, or equivalent.
- A minimum of 12 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech).
- Demonstrated ability to lead a high performing team.
- Extensive experience in Therapeutics Development.
- Extensive experience in analyzing clinical data and identifying signals and with data review software
- Track record of successfully managing phase 1, phase 2 and pivotal phase 3 programs, including registrational database locks.
- Experience with CRO oversight.
- Track record of leading development and implementation of new processes and roles.
- Track record of working with a diverse cross functional team, with ability to influence and align with key cross functional stakeholders.
- Proven leadership in clinical evaluation projects, including the development of protocols, case report forms, informed consent, study initiation, and monitoring.
- Exceptional abilities in data integrity, exploration, analysis, and presentation.
- Excellent written communication, oral communication, and presentation skills are required.
- Ability to travel up to 30% is required.
Here's What You'll Bring to the Table (Preferred Qualifications)- Track record of building a team.
- Oncology or autoimmune disease experience.
- Experience across multiple therapeutic areas.
- Submission and HA inspection experience.
Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.- Competitive healthcare, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
The salary range for this role is $243,100.00 - $437,000.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
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