layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Vice President, Clinical Development, Oncology at Xaira Therapeutics

Clinical development strategy
Develop and own integrated clinical development plans for priority oncology programs, from development candidate selection through clinical proof of concept and into registrational development.
Define target product profiles, indication and tumor type strategy, dose and schedule, endpoints, biomarker strategy to inform dose, proof of mechanism and accelerated development opportunities using patient selection approaches with insights from Xaira’s AI platform.
Translate insight from disease biology, functional genomics, proteomics, computational protein design, and translational studies into clinical hypotheses that can be tested in patients.
Establish pre-specified go/no-go criteria for each program and make timely, well-reasoned recommendations to advance, redirect, or discontinue.
IND enablement and first-in-human execution
Lead the clinical strategy and clinical content for IND and CTA submissions, including clinical development plans, first-in-human protocols, Investigator’s Brochure clinical sections, and briefing documents.
Establish starting dose, escalation scheme, and dose-limiting toxicity criteria in partnership with pharmacology, clinical pharmacology, PK/PD modeling, and toxicology, including MABEL or exposure-based approaches where appropriate.
Design Phase 1 studies that deliver both dose determination and mechanistic insight, incorporating contemporary escalation methodology such as BOIN, mTPI, or Bayesian model-based designs, backfill and expansion cohorts, and randomized dose optimization consistent with FDA Project Optimus expectations.
Provide scientific and medical oversight throughout Phase 1 execution, including cohort review, interpretation of emerging PK, pharmacodynamic, biomarker and response data, safety review committee and DSMB interactions, and protocol amendments.
Translational and biomarker-driven development
Working closely with the Translational Medicine team, define the translational and biomarker strategy for each program, including target engagement and pharmacodynamic endpoints, confirmation of mechanism of action in patients, characterization of resistance, and determination of the pharmacologically active dose range.
Partner with the Biomedical AI team and X-Patient AI Disease Modeling team to design data collection, analysis and interpretation aimed at generating hypotheses related to mechanism and disease segmentation to inform clinical development strategy through patient selection, tumor type selection and combinations.
Using data from the Translational platforms, including X-patient, design and implement patient selection strategy, including biomarker-defined populations, enrichment versus all-comers designs, assay selection and qualification, threshold definition, and the prospective evidence required to support a cut-off and CDx Assay Development.
Transition to late-stage development
Define and execute the path from dose expansion to registrational intent, including indication selection, single-arm versus randomized design, comparator and control strategy, endpoint selection across ORR, duration of response, PFS and OS and the assumptions underlying surrogacy, statistical considerations, and accelerated approval strategy where applicable.
Lead End-of-Phase 1 and End-of-Phase 2 interactions and expedited program designation strategy, and secure health authority alignment on registrational population, dose, and endpoints.
Ensure continuity of clinical, statistical, regulatory, operational, and diagnostic strategy into late-stage execution so that critical assumptions are not revisited in Phase 3.
Regulatory leadership and patient safety
Serve as the lead clinical representative in interactions with FDA, EMA, and other health authorities, and oversee clinical content across regulatory submissions, briefing packages, and responses.
Hold accountability for participant safety across clinical programs, including oversight of medical monitoring, evaluation of safety signals, and partnership with pharmacovigilance on risk management.
Ensure studies are conducted in accordance with GCP, ICH guidance, and applicable global regulatory requirements.
AI, data, and advanced analytics
Partner with Xaira scientists across BioMedical AI, computational biology, data science, engineering, biostatistics, and translational research to bring model-derived insight into clinical decision-making.
Apply molecular, single-cell, multi-omic, imaging, real-world, and clinical data to patient selection, biomarker strategy, dose selection, endpoint definition, and trial design.
Identify and prioritize practical applications of AI in oncology development, which may include trial simulation, dose–exposure–response modeling, protocol optimization, enrollment forecasting, digital pathology, external and synthetic control methods, predictive efficacy, and clinical data review.
Establish standards for data quality, validation, explainability, bias assessment, documentation, and human oversight wherever a model informs a clinical decision.
Design clinical studies so that the data generated also strengthens Xaira models and informs subsequent discovery and development, with tissue collection, sampling design, and consent structured accordingly.
Organizational leadership and external engagement
Build, lead, and develop the clinical development team, and establish the operating model, governance, and decision forums the organization requires as the pipeline expands.
Select and manage CROs, central and specialty laboratories, imaging and diagnostic vendors, and consultants, retaining scientific ownership and decision authority within Xaira.
Develop and manage the clinical development budget and resource plan in alignment with program milestones and corporate objectives.
Establish and maintain relationships with academic and community oncology investigators, cooperative groups, key opinion leaders, patient advocacy organizations, regulators, and prospective development partners, and chair advisory boards and steering committees.
Oversee scientific communication of clinical data through publications and congress presentations, and communicate program strategy, data, risk, and recommendations to senior leadership, the Board of Directors, and investors.

MD or MD/PhD required. Completion of residency and fellowship in medical oncology or hematology/oncology, with board certification, strongly preferred.
A minimum of 12 years of clinical development experience in the biotechnology or pharmaceutical industry, including at least 5 years in a leadership capacity with accountability for programs and direct reports.
Demonstrated oncology depth across more than one tumor type, with direct experience conducting dose-finding and dose-optimization studies in patients with advanced cancer.
IND and first-in-human leadership. Has led the clinical strategy and authored the clinical content for at least one oncology IND or CTA, and served as clinical lead for the resulting first-in-human study through escalation, dose optimization, and expansion.
Phase 1 to late-stage transition. Has advanced at least one oncology program from Phase 1 into successful late-stage or registrational development, and can articulate the dose, population, endpoint, and biomarker decisions that enabled the transition. Contribution to an approved oncology therapeutic is strongly preferred.
Biomarker-driven development. Demonstrated experience defining and executing biomarker strategy that materially influenced development decisions, spanning pharmacodynamics and target engagement, confirmation of mechanism of action in patients, and biomarker-based patient selection.
Direct experience applying AI, machine learning, or advanced analytics to a clinical development or translational question, with the ability to describe what was built, how it was validated, and how it changed a decision.
Extensive regulatory experience, including direct interaction with FDA and preferably EMA across IND or CTA submissions, End-of-Phase meetings, and expedited program pathways.
Sound scientific judgment regarding the limitations of computational methods, including the ability to interrogate model assumptions and to recognize when conventional analysis or direct clinical review is the better approach.
Excellent written and verbal communication skills, with experience presenting to executive leadership, Boards of Directors, health authorities, and external scientific audiences.
Demonstrated effectiveness in a fast-paced, resource-conscious environment requiring both strategic leadership and hands-on execution.

Vice President, Clinical Development, Oncology

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