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About the Job:
Meet with working with a public biotech company here in the Bay Area! They are advancing a clinical stage pipeline of differentiated treatments focused on chronic diseases with high unmet need. They are looking for an Associate Director of Program Management which can be worked remote (excluding monthly visits to the SF office). In this role will manage overall timelines, risks, and communication management ensuring all milestones and deliverables are met with high quality, on time and within budget. You would reporting to the VP of Program Management, and are expected to be well versed in clinical trial activities.
Creates and drives timelines to keep program(s) on schedule.
Facilitates highly effective team building and communication.
Partners with the Program Leader to optimize team effectiveness and decision making.
Drives information flow and communicates program status to all stakeholders in collaboration with the Program Leader.
Interfaces internally by acting as a liaison and facilitator of cross functional teams (i.e., Clinical Development, Clinical Operations, CMC, Tox, Regulatory, QA, Finance, BD, Marketing, etc.) in planning and executing trials.
Performs effective risk management assessments with the Program Team, the Program Leader, and stakeholders.
Identifies, develops and/or maintains an appropriate electronic platform (SharePoint, Shared Folders, etc.) for reporting/archiving/documentation of relevant program information, records, etc.
BA/BS is required, with an advanced degree (PharmD, PhD, MS, MBA, MD) preferred.
8+ years of work experience in industry, 5+ years of Program/Project Management experience, within a matrixed pharmaceutical or biotechnology organization.
Track record of leading development programs through all clinical phases of development.
Understanding of FDA and/or EMA quality and regulatory processes is required and experience with regulatory submissions is highly desired.
PMP certification is preferred.
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