Head of DMPK Preclinical Research (Associate Director/Director)

Orna Therapeutics is an innovative biotechnology startup based in Watertown, MA, committed to developing groundbreaking therapies for diseases that current approaches cannot address. With our pioneering circular RNA technology, developed at MIT, we are at the forefront of advancing the next generation of RNA therapeutics. Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.

We are looking for an experienced and talented DMPK group leader to join our team, with a focus on preclinical development of circRNA-LNP based therapies. The successful candidate will report to Head of Preclinical and will lead all DMPK efforts, ensuring the safe advancement of circRNA-LNP therapeutics from discovery through clinical development.

Responsibilities

• Provide DMPK strategy and data interpretation for RNA-LNP therapeutics including ADME characterization, DDI, PK, and PKPD analysis.
• Actively participate in program teams, lead the design and execution of PK, PKPD, and BioD studies, manage outsourced ADME studies, perform PKPD data analysis including PKPD modeling.
• Manage project deliverables and timeline, deliver and communicate results to project teams, provide scientific leadership, and contribute to decision making.
• Collaborate closely with internal teams in pharmacology, discovery, clinical development, and regulatory affairs to align DMPK strategy with overall program objectives.
• Contribute to the preparation and review of regulatory submissions, including INDs, CTAs, and IBs.
• Mentor and guide junior scientists within the preclinical department, promoting a culture of scientific excellence and teamwork.
  
  

Qualifications

• MSc or PhD in Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related disciplines with at least 6-8 years of experience within the biotechnology/pharmaceutical industry.
• Hands-on experience and strong trouble shooting skills for most in vitro and vivo DMPK studies, including PK and PK/PD analysis. Ability to gather most relevant information to facilitate human PK and dose projection. Experience with silico modeling and simulation tools is a plus.
• Strong analytical skills and the ability to make data-driven decisions in a cross-functional setting.
• Proven experience in regulatory filing and interactions with regulatory agencies.
• Experience in project and people management. Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions, and to incorporate feedback and ensure decisions are implemented swiftly.
• Excellent leadership, communication, and organizational skills, with the ability to thrive in a dynamic, fast-paced biotech environment.
• Familiarity with the unique safety considerations and regulatory requirements for RNA-LNP therapeutics.
  
  

Why Orna? At Orna Therapeutics, we’re more than just a workplace—we’re a community. We believe in fostering an environment where individuals can grow, thrive, and make a lasting impact on the future of healthcare. Join us as we revolutionize RNA therapeutics and make a difference in the lives of patients around the world.

Equal Employment Opportunity Statement

Individuals seeking employment at Orna Therapeutics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.