Associate Director, Clinical Documentation Operations

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens.

We are founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health and build a company that equalizes opportunity for people around the world by removing barriers of health inequity. Our aim is to have a global impact on human health; we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases. HIL-214 is our foundational vaccine candidate from which we are building the company.

Associate Director, Clinical Documentation Operations will serve as a subject matter expert and primary point of contact for activities associated with ensuring the Trial Master Files (TMFs) meet compliance, quality, archival, and inspection readiness standards. Support Functional Areas to oversee end to end TMF management incl. activities outsourced to CROs and Third Party Vendors

Responsibilities include but are not limited to:

• Define TMF management related processes and develop related tools.

• Support functional areas with execution of processes related to TMF management in accordance with the company guidelines and standard operating procedures.

• Support to produce inspection ready TMFs for ongoing and legacy studies.

• Define the TMF oversight process and support functional areas with its execution.

• Manage activities related to the TMF transfers from CROs and Third-Party Vendors and their long-term archiving in the HilleVax Veeva eTMF (Archive).

• Coordinate the work of contracted TMF Specialist(s) and CSV consultant(s).

• Provide TMF management related guidance and training to the HilleVax functions executing TMF management processes.

• Collaborate with CRO functions on development of study specific TMF process and on TMF quality issue follow-up until resolution.

• Performs activities related to the system administration of Veeva eTMF (Archive) incl. execution of change control process, if applicable, and Risk Impact Assessments related to the system upgrades.

• Other duties as assigned.

Minimum Requirements:

• BS/BA degree or equivalent (background in life sciences preferred).

• Familiar with ICH GCP and FDA rregulations.

• Detailed understanding of TMF and eTMF systems, principles, practices, and workflows.

• Experience maintaining and reviewing TMFs, including TMF artifact and indexing.

• Experience with the CDISC TMF Reference Model.

• Experience with oversight of TMF management activities performed by CROs and Third-Party Vendors.

• Ability to manage multiple projects and effectively prioritize activities.

• Experience with the TMF inspection preparations.

• At least 5 years of prior TMF experience.

Additional Qualifications / Experience Preferred:

• Experience with Veeva Vault eTMF.

• Good organizational skills, ability to manage multiple tasks simultaneously.

• Good written and verbal communication skills.

• Good written and spoken English.

• Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook, Visio.