Medical Director, Clinical Development

Arbor Biotechnologies™, a next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions – from the ultra-rare to the most common genetic diseases. The company’s unique suite of optimized gene editors goes beyond the limitations of early editing technologies to unlock access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need.

With Arbor’s lead program, ABO-101 for the treatment of primary hyperoxaluria type 1, progressing into clinical trials, the company continues to focus their research and development efforts on genomic diseases of the liver and CNS for which there are no existing functional cures. For more information, please visit: arbor.bio.

Passionate, determined, and accountable. Curious, resourceful, innovative, forward thinking, and resilient. Authentic, humble, open‑minded and puts team above self. At Arbor, our people embrace these qualities, so if this sounds like you then please read on!

The Medical Director, Clinical Development will provide medical, scientific, and operational leadership for clinical programs in rare and neurological diseases, with particular focus on early‑stage and proof‑of‑concept studies for gene‑editing therapeutics. Reporting to the Chief Medical Officer, this individual will serve as a senior clinical leader responsible for driving the design, execution, and optimization of clinical studies across global regions. A critical component of the role includes establishing and overseeing investigator‑initiated trials (IITs) in China, requiring strong bilingual communication skills (Mandarin/English) and the ability to travel to China to build and maintain key academic and operational partnerships.

This role is ideal for a physician‑scientist who thrives in a fast‑moving biotech environment, is hands‑on with clinical execution, and combines scientific rigor with operational excellence.

• Lead the design, medical oversight, and operational execution of clinical development strategies for rare and neurological disease programs, with emphasis on early development (FIH, Phase 1–2) and translational endpoints relevant to gene editing.
• Serve as clinical program lead, providing day‑to‑day medical and scientific leadership to ensure high‑quality clinical execution and data integrity.
• Partner closely with Research to integrate biomarker strategy, safety monitoring approaches (e.g., immunogenicity, off‑target assessments), and indication rationale.

• Establish, lead, and expand the company’s IIT footprint in China, including identifying investigators, developing protocols, and managing study start‑up, site activation, and operational oversight.
• Build strong relationships with principal investigators, hospitals, academic centers, and China‑based CRO partners.
• Ensure that all China IIT activities align with global clinical objectives, maintaining standards for scientific rigor, patient safety, regulatory compliance, and data quality.
• Create and refine operational processes that enable smooth execution of IITs, including contracting, budgeting, drug supply coordination, and safety reporting.

• Contribute to the development and refinement of clinical development plans and study protocols, ensuring alignment with global regulatory expectations.
• Support preparation of clinical documents for regulatory submissions (IND, CTA, NDA/BLA components, study reports), with specific focus on medical content and scientific rationale.
• Collaborate with regulatory affairs and region‑specific experts to ensure readiness for interactions with U.S., EU, and China regulatory agencies.

• Work closely with Clinical Operations, Regulatory, Project Management, CMC, Analytical Sciences, and Commercial to ensure integrated planning and execution.
• Partner with Research teams on indication selection, biomarker development, and advancing new…