Vice President of Translational Sciences

Vaga não está no LinkedIn

🕒 Julho 27

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Shasqi

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2015

🧬 Biotecnologia

💊 Farmacêutico

💰 $1.900.000 Grant em 2022-01

Biotechnology • Pharmaceuticals

A Shasqi é uma empresa de biotecnologia em estágio clínico que desenvolve uma plataforma de terapia tumoral pré-alvo chamada CAPAC (Click Activated Protodrugs Against Cancer), que utiliza química clic in-vivo para capturar e ativar cargas terapêuticas em tumores. Sua abordagem modular separa uma molécula clicável de ligação ao tumor de uma carga útil clicável inativa (radioisótopo ou protodroga de quimioterapia) que se torna ativada ou bloqueada no tumor após uma reação clic bio-ortogonal, visando aumentar a concentração do medicamento no tumor e reduzir a toxicidade sistêmica. A Shasqi relata validação clínica da plataforma e está avançando com ativos do pipeline e colaborações para levar terapias contra o câncer pré-alvo aos pacientes.

Descrição

• Accountable for the translational development strategy for pipeline assets from drug candidate through IND submission and Phase 1 entry. • Support translational hypotheses and biomarker strategies that connect preclinical biology to clinical endpoints. • Support indication selection frameworks and biomarker-driven go/no-go criteria that guide program progression decisions. • Support targeted patient stratification and enrichment strategies that inform clinical trial design and improve probability of success. • Identify and prioritize experiments, models, and data packages needed to support regulatory filings and clinical decision-making. • Partner with research and clinical leadership to align translational milestones with overall program strategy. • Characterize drug mechanisms of action and resistance to inform clinical hypotheses, patient selection, and combination strategies. • Lead the scientific content and coordination of IND-enabling activities, including PK/PD, safety, and biomarker packages. • Author and review translational sections of INDs, investigator brochures, and other regulatory documents. • Serve as the translational science lead in interactions with FDA and other regulatory agencies. • Ensure preclinical-to-clinical bridging is scientifically rigorous and clearly communicated. • Collaborate closely with Research (animal models, PK/PD, efficacy), Clinical Development, Clinical Operations, and CMC to ensure translational readiness at each program gate. • Support clinical protocol development by providing translational rationale for dosing, scheduling, patient selection, and biomarker collection. • Contribute to the design and interpretation of early clinical data to inform go/no-go decisions and Phase 2 design. • Build, mentor, and scale the translational science function as programs grow. • Identify and manage together with research and clinical leadership, academic collaborators, CROs, and biomarker labs that support translational programs. • Represent Shasqi's translational science at conferences, in publications, and in partnership discussions. • Co-author scientific publications, regulatory documents, and contribute to IP filings that protect and advance Shasqi’s platform. • Articulate Shasqi’s translational strategy and platform differentiation to the board and other external partners/investors as needed.

🎯 Requisitos

• Ph.D., M.D., or M.D./Ph.D. in oncology, pharmacology, cancer biology, or a related field. • 12+ years experience in translational oncology drug development at a biotech or pharma company, including personally leading and advancing at least two programs from preclinical candidates through IND filing and into Phase 1. • Deep understanding of IND-enabling studies and the preclinical data packages required by the FDA and other regulatory agencies. • Hands-on experience with PK/PD, biomarker strategy, and dose selection for oncology programs. • Strong scientific writing skills with experience authoring regulatory documents. • Ability to work at the bench-to-bedside interface in a small, fast-moving team. • Comfort being the most senior translational scientist in the company — supporting the design of studies and authoring regulatory documents directly, with limited support infrastructure and a high tolerance for ambiguity.

🏖️ Benefícios

• Competitive base salary as part of a broader total rewards package. • Equity: Included as part of total compensation. • Comprehensive benefits: medical, dental, vision, 401(k), short- and long-term disability. • Flexible PTO and a WFH stipend to support remote work. • Ongoing opportunities for professional development, growth, and mentorship.