Associate Clinical Safety Surveillance Director

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.


Who You Are

The Associate Clinical Safety Surveillance Director plays a key role in management and oversight of SAEs and events of special interest across our UT sponsored clinical trials. This position provides strategic direction to the team and vendors with respect to changes in business practices for efficiency, quality, and compliance impacts. Overall, this role is critical in ensuring that operational aspects of SAE/AESI collection, query management, etc. are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC developmental products.
 

• Function as a horizontal enterprise leader supporting safety governance architecture, inspection readiness posture, and sustained regulatory compliance across the UT Sponsored Clinical Trial portfolio by influencing strategy to address internal and external business and regulatory issues; serving and being recognized as an expert within organization, both inside and outside UT GPS; anticipating potential internal and/or external business challenges or regulatory issues and recommend solutions; developing the tools and knowledge requirements necessary for the developmental programs we support as it relates to pharmacovigilance
• Process Evaluation and Strategy: Evaluate, strategize, and execute process changes in response to regulatory updates, ensuring the effectiveness and efficiency of end-to-end clinical trial SAE and AESI handling for developmental pulmonary product(s); Initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives; Strategize and implement functional and department goals for the GPS Clinical Trial Oversight team
• Operational Oversight and Quality Assurance: Maintain unified SAE and AESI handling operating procedures (i.e. Safety Management Plan) and monitor systems to ensure all SAE and AESIs are processed and submitted per UT SOPs and industry standards; Evaluate and sign off on all SOPs related to SAE and AESI handling for developmental product(s); Ensure adherence to global safety regulations and guidelines by overseeing the collection, management, and reporting of safety data for UTC’s developmental programs, identifying risks and implementing corrective actions as needed.
• Regulatory Compliance and Guidance: Provide strategic guidance to ensure compliance with global regulations and guidelines for developmental PV case management, and reporting of ICSRs; Remain current on global regulations, guidelines and industry best practices for end-to-end developmental case management, ensuring compliance with global regulations and guidelines
• Stakeholder Management: Act as the main point of contact and functional manager for day-to-day questions or issue escalation regarding SAE and AESI handling processes; Participate in strategic discussions with other team members of GPS to ensure process compliance and operational input; Strategic oversight and management of GPS clinical trial oversight team metrics
• Training and Development: Develop, facilitate,