Associate Director, Clinical Sciences

Description

• 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.

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%.