Senior Project Manager - Global Medical Affairs

California, US residents click here.

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.

The Senior Project Manager of Medical Affairs will independently provide oversight and coordinate the operational delivery of local/regional clinical trials to ensure all study objectives are met, including adherence to required timelines, budget, quality, and performance expectations. This role ensures successful planning and completion of assigned projects, including clinical studies, registries, or other strategic study/departmental initiatives.

• Lead operations of clinical trial(s) from study start-up to close-out including ensuring study conducted in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations, and developing new SOPs as needed; coordinating and managing resources assigned to the study; and managing study budget, timelines, quality and performance expectations
• Serve as primary contact during clinical study/project, including regular collaboration, conferences calls and team meetings with appropriate functional areas, management and vendors as necessary
• Support insourcing/outsourcing partners to ensure they meet the required standards and expectations
• Significantly contribute to study concept, protocol, clinical study report as well as other critical study documents as required
• Lead vendor management, inclusive of selection, negotiation, implementation and management of vendor’s Statements of Work/Scope of Work (SOW)
• Plan, manage and report on all strategic study initiatives through oversight of cross-functional study activities; provide regular study updates to project team leads/senior management, if applicable
• Identify, resolve or escalate risks and issues involving study timelines and deliverables
• Establish, collect, track and report Key Performance Indicators (KPIs) such as query resolution, AE/SAE data collection, drug reconciliation/shipment, site and patient enrollment, etc. to company stakeholders
• Collaborate with team to ensure adequate protocol related and process training of all study team members; manage protocol deviations/violations to ensure proper documentation and proactively work with Investigative sites to reduce their occurrence
• Assist with preparation for interim and primary analysis reports, as applicable
• Participate in the development and refinement of relevant policies, guidelines, and SOPs
• Support the identification, contracting, and management of study-related steering/advisory committees
• Collaborate with clinical operations and other relevant functional groups (UT and / or CRO) to manage and engage with clinical study sites, ensuring milestone adherence
• Contribute to the development of study publication plans and review/preparation of study abstracts, manuscripts, etc.
• Provide first tier support for protocol, SOP and system questions; may serve as point of escalation for other project managers, if applicable
• Evaluate current processes for efficiencies an