Senior Director Program Management

Job Title: Senior Director Program Management

Job Number: 83454

Location: Remote, US

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.

Application Deadline: 2024-09-30