Senior Director Program Management

Job Title: Senior Director Program Management

Job Number: 35109

Location: Remote, 

Job Description

Responsibilities

• 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.