The Role This role will support Oncology Therapeutic programs, specifically supporting the Clinical Study Lead in the development, execution and evaluation of Phase 1-3 clinical studies. The principal responsibility for this role is to ensure the comprehensive data quality of clinical studies to support both internal governance decisions and regulatory submissions.
Here's What You'll DoBroadly stated, in conjunction with the Clinical Study Lead and the broader Clinical Trial Team, oversee end-to-end delivery of clinical trial protocols including study design, initiation, medical safety data monitoring, data dissemination and closeout activities.
Specifically:
- Collaborating with Clinical Operations, participate in the start-up of global clinical studies to ensure on-schedule site activation and subject enrollment of a clinical trial. Design and implement clinical study parameters to minimize operational risk and increase study site performance and efficiency. Collaborate on, and contribute to, inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
- Perform and coordinate clinical data review and analysis of study data, including review of case report forms, data listings, medical coding and patient profiles to ensure the proper and complete verification of clinical data.
- Collaborate with the Clinical Study Lead in the oversight of clinical studies. Provide review and interpretation of clinical data and ensure timely execution of deliverables in collaboration with both the Clinical Trial Team and external partners.
- In collaboration with the Clinical Study Lead and Clinical Safety & Pharmacovigilance, support managing study sites to ensure that study treatment discontinuation or other safety decisions are made in alignment with the protocol.
- Assist in the development of the content for Investigator Meetings, investigator engagements and Advisory Board meetings.
- Author and review clinical study documents in compliance with regulatory standards, including clinical protocols, informed consent documents, Development Safety Update Reports (DSUR) and clinical components of Investigator Brochures, INDs and marketing applications.
- Support and help drive the evolution of the clinical science role at Moderna and support process improvements. Participate in continuous Improvement initiatives related to the clinical trial delivery operating model.
Here's What You'll Need (Basic Qualifications)- The individual must have the demonstrated ability to successfully work in a team environment.
- This role is best suited for candidates holding a PhD, PharmD, Masters' or advanced nursing degree with significant scientific and clinical oncology knowledge, pharmaceutical/biotechnology company experience and a substantial knowledge of drug development.
- A minimum of 8 years of clinical development experience within a pharmaceutical/biotechnology company.
- Significant experience with ensuring clinical trial data integrity, data analysis, including exploratory analyses, and data presentation. Experience with Medidata Rave and clinical data analytics platforms (e.g. Elluminate, Spotfire) is preferred
- Excellent written communication, oral communication, and presentation skills.
- Ability to travel up to 15% required for travel to work with study sites and attend national and international scientific congresses.
- This role is based in our new LEED-certified HQ in Cambridge, MA, or Princeton, NJ office and is expected to be in-office 70% of the time with flexibility to work from home up to 30%.
Here's What You'll Bring to the Table (Preferred Qualifications):- A high-performing, self-motivated and energetic individual who demonstrates outstanding scientific and clinical oncology knowledge that results in the conduct of well-executed clinical research.
- A history of successfully operating in a matrix environment and the demonstration of highly developed interpersonal and communication skills.
- A personal and professional commitment to the highest personal and ethical standards.
- Capability to successfully contribute to both early and late-stage clinical development programs. This will involve close collaboration with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs and Commercial.
Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.- Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future
- Location-specific perks and extras
The salary range for this role is $158,600.00 - $285,500.00. 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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