Clinical Project Manager II​/Senior Clinical Project Manager

Position: Clinical Project Manager II / Senior Clinical Project Manager

California, US residents . The job details are as follows:
Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases.

We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need.

For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are

Imagine leading clinical studies that don't just meet milestones, but help redefine what's possible for patients waiting for better treatment options. As a Clinical Project Manager or Senior Clinical Project Manager, you'll have the autonomy to drive studies forward, the support of exceptional cross-functional teams, and a front-row seat to cutting-edge science. At United Therapeutics, our culture combines purpose, innovation, and determination with a genuine belief that work can be both meaningful and enjoyable.

If you're a proactive problem-solver who thrives on ownership, collaboration, and making a real impact, you'll find both challenge and fulfillment here.
• Work independently to ensure the success of a local or regional clinical trial.
• Provide oversight and coordination for the operational delivery of ongoing local or regional clinical trials to ensure all required timelines are met as well as adherence to budget, quality, and performance expectations.
• Utilize advanced expertise and serve as the primary study contact for study-related communication, coordinating with teams, management, and vendors
• Independently oversee the entire lifecycle of clinical trials, from start-up to close-out
• Direct local or regional clinical trials, ensuring cross-functional activities align with study objectives
• Administer study budgets and timelines, maintaining high-quality standards and performance metrics
• Identify, resolve, or elevate any concerns regarding study timelines and deliverables promptly
• Proactively raise performance related concerns with appropriate line management
• Manage protocol deviations/violations diligently, reducing their occurrence through proactive collaboration
• Collaborate with Clinical Operations to monitor key performance indicators, enhancing study efficiency
• Provide consistent updates on study progress to the project team and management
• Manage in sourcing / outsourcing partners, ensuring compliance with standards and expectations
• Contribute to the development of study concepts, protocols, and critical study documents
• Engage in the creation of policies, guidelines, and SOPs, contributing to the advancement of Clinical Operations and Study Management
• Assess and enhance current processes, recommending improvements to management
• Ensure study conduct aligns with SOPs, ICH/GCP guidelines, and local regulations
• Manage vendor relationships, including selection, negotiation, implementation, and statement of work (SOW) oversight
• Ensure comprehensive protocol and process training for all study team members
• Manage resources allocated to the study, excluding staff management
• Review and endorse team member transition plans as necessary
• Assist in the preparation of interim and primary analysis reports
• Organize and oversee Investigator Meetings, ensuring effective coordination
• Perform all other duties as required
Education and Experience requirements for Clinical Project Manager II level
• Bachelor’s degree in related field and 8+ years of related clinical study management or project management experience in…