Associate Clinical Safety Surveillance Director

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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, and provide training and training materials for SAE and AESI handling for developmental product(s) in accordance with SOPs, global regulations, guidelines, SMPs, and conventions for investigator sites, investigators and others; Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)
• Inspection and Audit Management: Act as the point of contact for inspections and audits related to UT GCP safety operations handling activities; Conduct root cause analysis of inspection or audit findings and ensure appropriate CAPA is in place to address the findings; Review and approve deviations/CAPAs for any related activity as necessary
• SOP and Procedural Document Management: Initiate and lead the development and implementation of new or revised SOPs; Update and maintain procedural documents to reflect current practice related to GPS SAE and AESI case handling/operational handling.
• Remain current on all global and local GCP and GVP regulations supporting Clinical Trials in the PV setting
• Perform additional responsibilities as required, ensuring alignment with corporate strategy and evolving business needs

Minimum Requirements

• Bachelor’s Degree in a related field (chemistry or biology), or BSN, and 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases), or
• Master’s Degree in a related field (chemistry or biology), and 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases), or
• Doctor of Pharmacy (PharmD) PhD, MD/DO or international equivalent, and 7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases)
• 5+ years of experience in vendor management and/or CT oversight
• 5+ years of clinical trial or product development experience
• 3+ years of previous functional lead/people management experience
• Previous experience using Argus (preferred) or other safety databases
• End-to-end case processing (including data entry, QC, medical review, regulatory submissions)
• Project management skills and ability to organize and deliver large, complex projects independently
• Working knowledge of drug development processes and activities, including but not limited to having the ability to explain the legislative framework supporting all aspects of drug development & registration of medicines, ensuring their safety
• Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, and drug products (in development)
• Working knowledge of MedDRA coding
• Strong written and verbal communication skills, including but not limited to the ability to communicate safety issues in a variety of formats required to meet the needs of the intended audience and contributors
• Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions
• Ability to work effectively across functions; understands objectives, activities, and required contributions of internal partner functions
• Willing and able to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
• Adaptable and can work effectively in ambiguous situations
• Prior clinical PV management experience

Job Location

This position will be located at our Durham, NC office with a hybrid schedule of at least 3 days in office each week. In office requirements could change based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.