Director, Translational Clinical Development · Job Description

Position Description

Director, Translational Clinical Development

Make effective brain-targeted therapies possible.

Reports to · Founding Scientist Full-time Remote · Miami, FL Lotus Neuro, Inc.

Company Overview

Lotus Neuro is a clinical-stage therapeutics development company pioneering a novel approach to treating some of the most intractable diseases of the brain. The company leverages a proven and proprietary low-frequency focused ultrasound (LOFUS) technology to open the blood–brain barrier non-invasively and transiently, which, in combination with advanced therapeutics, creates a new pathway for treating complex brain diseases. To date, the platform has been used in nearly 600 therapeutic cycles across indications including brain tumors, Alzheimer's disease, Parkinson's disease, and ALS.

Lotus Neuro was launched in December 2025 as a spinout of Insightec, a global medical technology company focused on realizing the therapeutic power of acoustic energy.

Technology and Approach

Lotus Neuro aims to advance the next generation of brain-targeted therapies with unprecedented precision and control. The company's LOFUS technology can non-invasively and precisely open the blood–brain barrier, creating a transient and repeatable gateway into the brain that can be personalized to a patient's disease, anatomy, and therapeutic regimen. Beyond opening the blood–brain barrier, LOFUS may also augment therapeutic effect by enhancing target exposure, modulating biology at the site of delivery, and improving the conditions under which a therapeutic can act.

Lotus Neuro is partnering with leading biopharma companies and research institutions to build a pipeline of clinical-stage programs, initially focused in neuro-oncology and with plans to expand into neurodegenerative diseases and beyond. The platform can be paired with multiple therapeutic modalities, including ADCs, AAV, siRNAs, ASOs, biologics, enzymes, cell therapies, mRNA, and radiopharmaceuticals.

Pipeline

Lotus Neuro is advancing a portfolio of programs that pair LOFUS with high-value therapeutic assets across modalities. Initial clinical focus is in neuro-oncology, with a near-term expansion into selected neurodegenerative indications. Current areas of emphasis include:

  • Glioblastoma (GBM), where multicenter clinical evidence supports LOFUS-enabled delivery strategies and window-of-opportunity trials demonstrate combination value.
  • Diffuse intrinsic pontine glioma and diffuse midline glioma (DIPG / DMG), where the company is engaging academic clinical leaders to define modality and sequencing.
  • Neurodegenerative expansion, where forward investment is intended to characterize LOFUS in combination with disease-modifying therapies in Alzheimer's disease, Parkinson's disease, ALS, and other selected CNS indications.
  • Other neurological diseases requiring focal-regional drug delivery.

The Opportunity

As Lotus Neuro advances its first combination programs toward the clinic and prepares to expand into neurodegenerative disease programs, the company is recruiting a Director, Translational Clinical Development to serve as a hands-on physician-scientist leader across translational and early clinical development. This is a builder's role for an individual who can operate effectively at the interface of preclinical science, translational strategy, clinical development, protocol design, and investigator engagement.

Working directly with the Founding Scientist and in close collaboration with the platform team, this individual will help shape how LOFUS-enabled programs move from preclinical rationale into clinically executable studies. The role is intended for a clinically sophisticated physician-scientist who can contribute to preclinical experiment design and analysis, protocol development, translational endpoint design, site and investigator strategy, and early clinical execution in a lean, highly collaborative company model.

The Position

The Director, Translational Clinical Development will report to and partner closely with Ajay Verma, MD, PhD, Founding Scientist. The Founding Scientist owns the scientific and translational strategy that underwrites Lotus Neuro's partnered and internal programs, including mechanistic science, translational thesis, scientific diligence, and scientific partnership development.

Within that context, the Director will serve as a key bridge between preclinical experimentation, translational strategy, and clinical execution. This individual will help design and analyze preclinical studies, ensure that program concepts are clinically grounded, shape translational packages with protocol feasibility in mind, and align clinical study plans with the needs of investigators, patients, sites, and partners. The Director will also interface with external PIs that carry out Lotus-partnered studies.

This role is a high-impact hybrid role spanning preclinical and translational development, clinical strategy, protocol support, and investigator engagement, working in coordination with external regulatory, safety, and clinical-operations resources as the company builds internal capability over time.

Key Responsibilities

  • Co-develop and help author clinical protocols for LOFUS-enabled neuro-oncology studies, including window-of-opportunity (WOO) studies and subsequent Phase 1 safety and signal-seeking protocols or expansion protocols.
  • Provide clinical and translational input on study design, patient-selection strategy, endpoint selection, imaging plans, PK/PD strategy, biomarker integration, and protocol feasibility.
  • Contribute to the design, execution strategy, analysis, and interpretation of preclinical experiments that support LOFUS-enabled programs, including studies informing mechanism, biodistribution, PK/PD, biomarker strategy, and translational go/no-go decisions.
  • Help translate preclinical findings into clinically meaningful development plans, ensuring that go/no-go criteria and translational readouts are relevant to clinical decision-making.
  • Support clinical evaluation of candidate assets for LOFUS-enabled delivery, including mechanism, target biology, clinical practicality, safety considerations, and fit with neuro-oncology and future neurodegenerative development paths.
  • Contribute clinical and scientific perspective to business-development discussions, diligence processes, and asset prioritization efforts.
  • Help extend Lotus Neuro's development framework beyond neuro-oncology into neurodegenerative disease programs, including Alzheimer's disease, Parkinson's disease, ALS, and other selected CNS indications.
  • Build and steward relationships with investigators, sites, and multidisciplinary leaders across neuro-oncology, neurosurgery, neuroradiology, radiation oncology, pediatric neuro-oncology, and relevant neurodegenerative disease networks.
  • Help identify and onboard sites capable of executing complex CNS delivery studies, particularly those requiring close procedural, imaging, and translational coordination.
  • Partner with external clinical-operations, regulatory, safety, and medical-monitoring resources to support compliant, efficient study startup and execution.
  • Work with the Founding Scientist and platform team on the clinically relevant aspects of LOFUS delivery, including treatment workflow, imaging integration, procedural considerations, and patient-safety implications for protocol design.
  • Champion scientific rigor, data quality, reproducibility, and operational discipline across the preclinical-to-translational-to-clinical handoff.
  • Assist in evaluating potential business development opportunities.

The Individual

Professional

Lotus Neuro is seeking a clinically trained physician-scientist with meaningful experience in neuro-oncology, neurosurgery, CNS oncology, neurodegeneration, or a closely related field. The ideal candidate brings strong translational instincts, hands-on involvement in clinical research, and the ability to contribute meaningfully to preclinical experiment design and data interpretation, along with the judgment to help shape first-in-class development programs in a resource-efficient environment.

The strongest candidates will likely have experience as a protocol contributor, principal investigator, co-investigator, or site-facing clinical leader in early-phase, investigator-initiated, or sponsor-supported studies. Experience engaging multidisciplinary teams, working with imaging-rich or procedure-based studies, and helping connect preclinical and translational science to clinical execution will be especially valuable.

Experience with neuro-oncology, glioblastoma, high-grade glioma, pediatric neuro-oncology, neurodegenerative disease, or adjacent CNS diseases is strongly preferred. Familiarity with device-enabled studies, image-guided interventions, focused ultrasound, radiosurgery, intraoperative delivery, or other complex interventional platforms would be highly valuable. Exposure to advanced imaging, ctDNA, PK/PD, biomarker-informed clinical development, or preclinical translational models is also a strong plus.

Experience contributing to regulatory documentation, combination drug-device programs, or sponsor-side clinical development is desirable, but candidates need not have previously served as a full medical monitor or sole regulatory lead.

Personal

The ideal candidate combines clinical credibility and scientific depth with a hands-on, collaborative, get-it-done working style. This person is rigorous and detail-oriented, but also pragmatic, flexible, and comfortable operating in a fast-paced entrepreneurial environment.

They should be able to move fluidly between experimental design discussion, translational debate, investigator interaction, and study-planning detail. Strong communication skills, sound judgment, organizational discipline, and a genuine enthusiasm for building something novel are essential.

Educational

An MD/PhD is strongly preferred, ideally with neurosurgery, neuro-oncology, neurology, neurodegeneration, or closely related CNS clinical training. An MD or PhD in a relevant discipline with substantial translational and clinical-development experience will also be considered. Board certification or eligibility in neurosurgery, neurology, oncology, or a related field is a plus.

As with all Lotus Neuro roles, demonstrated accomplishment, scientific and clinical judgment, work ethic, adaptability, and ability to operate effectively in an early-stage environment will weigh as heavily as formal credentials.

Core Values

It is critical that the Director, Translational Clinical Development embrace and embody Lotus Neuro's core values:

  • Lead with Love. Lead with humility, integrity of intent, and a commitment to elevate others.
  • Own the Challenge. Take responsibility, pursue excellence, and solve problems proactively.
  • Thrive through Failure. Learn fast, speak openly, and move forward stronger through adversity.

Location and Working Model

Lotus Neuro operates as a virtual company with Miami, Florida as its corporate home. This role can be performed remotely. The Director, Translational Clinical Development will have regular travel to Boston, Miami, Maryland, and the Lotus Neuro clinical site network in the United States and abroad.

Where Barriers Fall Apply · careers@lotusneuro.com