"Research Associate"

The UNC HIV Cure Center aims to discover, develop, and implement new treatments leading to the cure of HIV infection. The HIV Cure Center seeks a highly motivated and experienced Project Manager to lead and coordinate drug development initiatives now in clinical translation. This position will advise the Cure Center director, facilitate collaboration between academic investigators, industry partners, and regulatory agencies, and ensure projects progress on time and within scope. The successful candidate will bring expertise in pharmaceutical development, regulatory requirements, and project management to advance novel therapeutics toward clinical application. The primary purpose of this position will be to obtain and manage an IND for the clinical development of a primary UNC HIV Cure center asset in human trials, manage and interact with contractors for drug production, prepare submissions to IRB and other regulatory bodies including external IRBs, FDA and NIH, and communicate with staff, sponsors, and monitors regarding regulatory issues for clinical trial protocols, including multicenter and IND studies.

The UNC HIV Cure Center Sponsored Clinical Research team is primarily responsible for the clinical development, regulatory strategic management, and FDA interactions for sponsored trials. This position will provide strategic and tactical leadership to UNC investigators in support of their interdisciplinary drug/biologic clinical and translational protocol development and regulatory submissions. This position will collaborate in writing, editing, producing, and reviewing clinical and/or translational oncology clinical trial protocols. This position will author strategic amendments to clinical protocols. This individual will aid in the authoring of LOIs (letters of intent) and the development of grants to support these clinical and translational protocols. The individual will assist in the preparation of Investigational New Drug (IND) serial submissions and respond to queries from the Food and Drug Administration (FDA).

Education and Experience:

• Have a strong record of experience in medical writing or protocol writing and working knowledge of the following: federal and local regulations of clinical trials (including drug development and biostatistics).
• Must be able to manage multiple projects at various stages and be able to work independently with occasional guidance from physician leadership or management.
• Master's degree in pharmaceutical sciences, biomedical sciences, clinical research, or a related field; PhD or PharmD preferred.
• Minimum of 5 years of experience in drug development, translational research, or clinical trial management.
• Project management certification (PMP or equivalent).
• Demonstrated experience with regulatory submissions and compliance in an academic or industry setting.

Essential Skills:

• Strong understanding of the drug development process, including preclinical, clinical, and regulatory milestones.
• Excellent organizational and leadership skills with the ability to manage multiple complex projects simultaneously.
• Exceptional written and verbal communication skills, including experience preparing scientific and regulatory documents.
• Ability to foster collaboration across diverse stakeholders in academic, clinical, and industry settings.
• Proficiency in project management tools and Microsoft Office Suite.

AA/EEO Statement:

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.