Associate Xeno and Translational Safety Director

United Therapeutics Corporation

22h•Hybrid

About The Position

The Associate Xeno & Translational Safety Director provides scientific and operational leadership within the organovigilance and translational safety function. This role is responsible for advancing the safety framework for xenotransplantation and other organ-based therapies, integrating translational insights with patient safety principles to support data-driven safety governance across development programs & future commercialization activities. Lead end-to-end scientific oversight of serious adverse event (SAE) management across organ-based and xenotransplantation programs, including data quality review, regulatory submissions, safety data analytics, and timely escalation of critical safety issues Author, critically review, and provide scientific leadership for core safety deliverables including DSURs, RMPs, CSIs, and related regulatory documents, ensuring scientific rigor, regulatory alignment, and consistency across programs Establish and operationalize an integrated organovigilance framework that enables proactive risk identification and management of complex safety activities Provide strategic input to safety governance forums through evaluation and interpretation of emerging and validated safety signals, contributing to benefit–risk assessments and safety strategy Integrate translational, nonclinical, and clinical safety data to characterize evolving safety profiles, inform organ-specific risk assessments, and guide safety strategy across the program lifecycle Partner with Clinical Development, Nonclinical Safety, Regulatory Affairs, Organ Quality, Organ procurement and management teams to ensure aligned safety strategy, operational continuity, and data integrity across the program Collaborate with vendors, development QPPV, medical monitors, CRAs, KOLs and other medical professionals to ensure accurate safety data flow, quality oversight, and timely escalation of critical safety issues Contribute to continuous improvement of organovigilance processes, systems, and analytical approaches to enhance safety oversight and support the development of novel organ-based therapies Mentor junior scientists and safety specialists, fostering development of translational, data-driven approaches to organovigilance practice Perform other duties as assigned

Requirements

Master’s Degree in biomedical sciences or a related field or Registered Nurse (RN) or Doctor of Philosophy (PhD) or Doctor of Pharmacy (PharmD) or MD
12+ years of experience in pharmacovigilance, clinical safety, or translational science within the biopharmaceutical industry with a RN license or 10+ years of experience in pharmacovigilance, clinical safety, or translational science within the biopharmaceutical industry with a Master's Degree or 7+ years of experience in pharmacovigilance, clinical safety, or translational science within the biopharmaceutical industry with a PhD/PharmD/MD/DO
Demonstrated expertise in case management, data review, and authorship or contribution to regulatory safety reports (DSUR, RMPs, CSIs)
Experience supporting novel or complex therapeutic modalities such as xenotransplantation, regenerative medicine, or cellular therapies
Strong analytical, scientific, and collaborative skills to support cross-functional safety decision-making
Proven ability to translate scientific insights into actionable safety strategies aligned with organizational and regulatory expectations
Demonstrates qualities of competency and accountability and ability to work effectively in ambiguous situations and under pressure in a fast-paced environment
Demonstrated ability to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
Strong computer skills with intermediate experience working with PV software (Argus and Empirica) and advanced experience with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Strong communication and interpersonal skills

Nice To Haves

6+ years of experience managing a team of direct reports

Responsibilities

Lead end-to-end scientific oversight of serious adverse event (SAE) management across organ-based and xenotransplantation programs, including data quality review, regulatory submissions, safety data analytics, and timely escalation of critical safety issues
Author, critically review, and provide scientific leadership for core safety deliverables including DSURs, RMPs, CSIs, and related regulatory documents, ensuring scientific rigor, regulatory alignment, and consistency across programs
Establish and operationalize an integrated organovigilance framework that enables proactive risk identification and management of complex safety activities
Provide strategic input to safety governance forums through evaluation and interpretation of emerging and validated safety signals, contributing to benefit–risk assessments and safety strategy
Integrate translational, nonclinical, and clinical safety data to characterize evolving safety profiles, inform organ-specific risk assessments, and guide safety strategy across the program lifecycle
Partner with Clinical Development, Nonclinical Safety, Regulatory Affairs, Organ Quality, Organ procurement and management teams to ensure aligned safety strategy, operational continuity, and data integrity across the program
Collaborate with vendors, development QPPV, medical monitors, CRAs, KOLs and other medical professionals to ensure accurate safety data flow, quality oversight, and timely escalation of critical safety issues
Contribute to continuous improvement of organovigilance processes, systems, and analytical approaches to enhance safety oversight and support the development of novel organ-based therapies
Mentor junior scientists and safety specialists, fostering development of translational, data-driven approaches to organovigilance practice
Perform other duties as assigned