Associate Xeno and Translational Safety 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 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

Minimum 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

Preferred Qualifications

• 6+ years of experience managing a team of direct reports

Location

This position is located at our RTP, NC office with a hybrid schedule of 3 days in office, and the option to work 2 days each week from home. 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.

Biotechnology company focused on pulmonary arterial hypertension and organ transplant therapies. Headquartered in Silver Spring, MD.

unither.com