Senior Director of Translational Sciences

LB Pharmaceuticals

About The Position

The Senior Director of Translational Sciences will be a key scientific and strategic leader within LB Pharmaceuticals, reporting directly to the Chief Business Officer (CBO). This individual will be responsible for driving the company’s translational science strategy, bridging preclinical, clinical, and biomarker efforts to accelerate development and elucidate the mechanism of LB-102 and other pipeline assets. This individual will also have primary responsibility for the design and conduct of NDA-enabling non-clinical pharmacology studies for LB-102 and be responsible for the oversight of the non-clinical pharmacokinetic, safety pharmacology and toxicology program. As a senior leader in a small, public, fast-paced company, this role requires a hands-on, highly collaborative individual who can combine deep scientific expertise and strategic thinking with entrepreneurial agility to independently drive research projects required to advance programs from discovery through clinical commercialization. Communication with internal and external stakeholders of study findings and the non-clinical pharmacology strategy will be critical. Therefore, the candidate must possess excellent written and oral communication skills. This is a hands-on leadership role in a small-company environment, requiring the ability to balance strategic thinking with tactical execution.

Requirements

PhD, MD, or MD/PhD in Neuroscience, Pharmacology, Molecular Biology, or related discipline.
10+ years of relevant industry experience in translational sciences, biomarker development, or neuroscience drug development, with at least 5 years in a leadership role.
Demonstrated expertise in biomarker identification, assay development, and application to clinical trials in CNS/neuropsychiatric diseases preferred.
Strong understanding of clinical trial design and regulatory requirements.
Experience with translational endpoints in psychiatric indications preferred.
Proven track record of leading cross-functional teams and external collaborations in a biotech or pharmaceutical setting.
Excellent communication, presentation, and scientific writing skills, with experience interacting with senior executives, regulators, and external partners.
Experience with authoring, reviewing and finalizing non-clinical and clinical summary documents or response documents preferred
Entrepreneurial mindset with the ability to thrive in a fast-paced, small-company environment

Responsibilities

Lead the design, implementation, and execution of translational science strategies for LB-102 and pipeline programs, ensuring alignment with corporate timelines and objectives.
Lead the design and implementation of NDA-enabling non-clinical studies for LB-102 to support planned regulatory submissions for schizophrenia and bipolar depression.
Identify and validate biomarkers (pharmacodynamic, predictive, prognostic, and safety) to inform patient stratification, treatment response, and regulatory strategy.
Serve as the internal subject matter expert on pre-clinical and translational science, neuroscience, and biomarker approaches for neuropsychiatric drug development.
Oversee preclinical research that supports clinical programs, including mechanism-of-action studies, biomarker validation, and pharmacology assessments.
Partner closely with Clinical Development and Regulatory to integrate translational hypotheses and biomarker endpoints into clinical trial designs and regulatory submissions as appropriate.
Experience working with device and drug combinations
Drive the reverse-translation of clinical findings back into research to refine hypotheses and guide future studies.
Author, review, and finalize non-clinical pharmacology modules and clinical pharmacology modules for IND and NDA submissions
Support authoring, review and finalization of Health Authority response documents regarding non-clinical topics
Establish and manage relationships with academic collaborators, CROs, and strategic partners to advance biomarker discovery and translational efforts.
Represent LB Pharmaceuticals at scientific meetings, conferences, and with key external stakeholders to position the company as a leader in neuropsychiatric translational science.
Contribute to scientific publications, regulatory submissions, and investor-facing communications.
Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, CMC, and Commercial to ensure translational efforts support overall program success and differentiation in the market.
Support cross functional project teams through provision of research support necessary to advance development of LB-102 and other pipeline assets
Provide strategic input to executive leadership and the Board of Directors on translational science initiatives and progress.
Mentor and build a small but high-impact translational sciences team, fostering a culture of scientific rigor, innovation, and accountability.