Vice President, Clinical Development, Oncology

1 нед. назад

СШАHeadOnsite

clinical developmentclinical trial designind submissiononcology

Lead clinical development strategy and execution for oncology portfolio from discovery to late-stage clinical development.

О компании

Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and antibody therapeutics, enabling the creation of medicines against historically hard-to-drug molecular targets. It is also developing foundation models for biology and disease to enable better target elucidation and patient stratification. Collectively, these technologies aim to continually enable the identification of novel therapies and to improve success in drug development. Xaira is headquartered in the San Francisco Bay Area, Seattle, and London.

Требования

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.

Будет плюсом

Experience with modalities lacking established clinical precedent, including engineered proteins and antibodies, bispecific and multispecific antibodies, antibody–drug conjugates, targeted protein degraders, or cell and gene therapy.
Companion diagnostic co-development experience, including regulatory approval of a biomarker-defined indication.
Experimental medicine, adaptive and model-informed drug development, dose–exposure–response analysis, and seamless Phase 1/2 designs.
Digital pathology or digital endpoints, causal inference, external control methodology, and real-world oncology data.
Regulatory experience involving novel analytics, AI-derived biomarkers, digital measures, or non-traditional approaches to evidence generation.
Prior clinical leadership within an AI-native biotechnology company, a computational drug discovery company, or a pharmaceutical AI and data organization.
Experience establishing an early clinical development function within a growing organization.

Условия

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $350,000 to $407,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.
an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.
TO ALL RECRUITMENT AGENCIES: does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. is not responsible for any fees related to unsolicited resumes.

Другое

is seeking a Vice President, Early Clinical Development to lead development of the company’s oncology portfolio as it advances from discovery into the clinic. Reporting to the Senior Vice President, Translational Science and Early Clinical Development, the Vice President will be accountable for clinical development strategy, IND-enabling clinical planning, first-in-human study design and execution, and the progression of priority programs through clinical proof of concept and into late-stage development.
This is a founding clinical development role. The Vice President will establish the clinical development function at Xaira, including its people, operating model, governance, and external network, and will serve as a visible member of the R&D leadership team with influence over portfolio strategy.
Xaira integrates AI, computational biology, and large-scale experimental data across the discovery and development continuum. The Vice President will be expected to apply advanced analytics and model-derived insight to development strategy, trial design, patient selection, and evidence generation, and to exercise disciplined judgment about where these methods add value and where conventional approaches remain the better answer.
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.
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.
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.
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.
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.
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.
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.
This position is based onsite at Xaira’s South San Francisco headquarters. Travel of approximately [15–25%] is expected for investigator and site engagement, scientific congresses, health authority meetings, and partner interactions.