Vice President of Translational Sciences

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Shasqi

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2015

🧬 Biotechnologie

💊 Pharmazie

💰 €1.900.000 Grant im 2022-01

Biotechnology • Pharmaceuticals

Shasqi ist ein Biotechnologieunternehmen in der klinischen Phase, das eine Pre-Targeting-Tumortherapieplattform namens CAPAC (Click Activated Protodrugs Against Cancer) entwickelt. Diese Plattform nutzt in-vivo Click-Chemie, um therapeutische Nutzlasten in Tumoren zu erfassen und zu aktivieren. Ihr modularer Ansatz trennt ein tumorbindendes klickfähiges Molekül von einer inerten klickfähigen Nutzlast (Radioisotop oder Chemotherapie-Protodrug), die nach einer bioorthogonalen Klickreaktion am Tumor aktiviert oder fixiert wird. Ziel ist es, die Wirkstoffkonzentration im Tumor zu erhöhen und die systemische Toxizität zu reduzieren. Shasqi berichtet über die klinische Validierung der Plattform und treibt Pipeline-Assets und Partnerschaften voran, um Pre-Targeting-Krebstherapien zu den Patienten zu bringen.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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.