Collaborate w/ Executive & Management team to enable strategy and execution of Ph III PAH program; ensure working group meetings are agenda-focused to enable efficient decision-making
Collaborate with Clinical Team Leaders to enable team development and follow-through of the Clinical Plan (e.g., partnering with, and gaining cross- functional alignment on deliverables)
Facilitate team development and management of Risk Mitigation Plan
Build, maintain and control the cross functional timeline for the execution of Clinical Development Plan to NDA/MAA filing - highlight dependencies, milestones, deliverables, and critical path; create timeline scenarios as needed and facilitate cross- functional reviews
Identify and leverage interdependencies in short-, mid-, and long-term project and study plans
Ensure functions are tracking to key deliverable and milestone timelines.
Play a cross functional leadership role in identifying, designing and implementing strategic initiatives that impact the Ph III PAH program.
Portfolio management: manage program and project prioritization with the leadership team
Institutes and leads cross-functional program teams consisting of representatives from the functional groups and Finance.
Works with the Development Program Team Leadership to align processes for effective meeting management, eliciting productive, behavior, and team member accountability across teams.
Leads program teams to define and manage deliverables and timelines, facilitate decision making, and define risk mitigation strategies/contingencies.
Leads and facilitates meetings at all levels of the organization to ensure cross alignment to corporate strategy and to manage execution of plans to meet objectives.
Required Skills
BA/BS degree required; advanced degree preferred
Experience in project management with the ability to develop clear action plans and execute
PMP or PMI certification beneficial but not required
Strong leader with 12+ years’ experience with a minimum of 8-10 years of program management experience in biotech/life sciences industry
Experience in developing and leading high-performance cross-functional teams to achieve desired outcomes with internal and external teams
Experience managing multiple complex programs and demonstrated adeptness with dynamic prioritization of deliverables and resources
Experience focused on late stage clinical trials with hands on experience in filing an NDA with the FDA
Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
Seniority level
Director
Employment type
Full-time
Job function
Project Management
Industries
Biotechnology
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