Vice President, Development

🕒 vor 27 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $310.000 - $360.000 / Jahr

⏰ Vollzeit

🔴 Experte

👔 Vizepräsident

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GondolaBio

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2024

🏥 Gesundheitswesen

💼 Beratung

🏭 Fertigung

💰 €300.000.000 Venture Round - GondolaBio im 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das 2024 gegründet wurde und mit BridgeBio Pharma verbunden ist. Es konzentriert sich darauf, bahnbrechende Therapeutika für Patienten mit genetischen Erkrankungen zu entwickeln. Das Unternehmen nutzt einen schlanken, dezentralisierten Ansatz, um die frühe Forschung und Entwicklung über mehrere Modalitäten hinweg zu beschleunigen (einschließlich niedermolekularer und Oligonukleotid-Therapien). Es baut eine vielfältige Pipeline auf, die seltene und unterversorgte genetische Bedingungen wie EPP/XLP mit seinem Hauptprogramm PORT-77 ins Visier nimmt. GondolaBio stellt die Bedürfnisse der Patienten in den Mittelpunkt und zielt darauf ab, krankheitsmodifizierende Behandlungen schneller den Bevölkerungsgruppen zugänglich zu machen, die noch keine zugelassenen Therapien haben.

Beschreibung

• Provide scientific strategy and operational leadership across the development sciences functions that take genetic disease programs from candidate selection through first-in-human and early clinical development, including: • Nonclinical Pharmacology & DMPK Sciences • Direct nonclinical PK/PD strategy spanning target engagement, pharmacodynamic response, and efficacy. • Oversee in vitro and in vivo ADME and DMPK characterization to support candidate selection and IND-enabling packages. • Biomarker Sciences & Development • Lead biomarker identification and the nonclinical-to-clinical biomarker strategy and execution. • Drive clinical biomarker qualifications to support proof of mechanism and proof of concept. • Clinical Pharmacology & Early Clinical Development • Own first-in-human through Phase 2 early clinical sciences and development strategy. • Direct clinical pharmacology, including Phase 1 healthy-volunteer and special-population studies. • Quantitative Sciences • Provide leadership across data analytics, pharmacometrics, biostatistics, and data management and data sciences to inform dose selection and program decisions. • Research Operations • Oversee nonclinical and translational study execution and vendor management. • Manage clinical pharmacology study execution and associated vendor relationships. • Bioanalytical Sciences • Direct bioanalytical assay development for PK, biomarkers, and immunogenicity. • Oversee nonclinical and clinical bioanalytical operations. • Cross-Functional Leadership • Partner closely with Clinical Development, Global Regulatory Affairs, CMC, and Research to deliver integrated development plans and regulatory submissions (pre-IND, IND, FIH, Phase 1/2). • Personally drive the technical work across these functions, staying close to the science and the data while leveraging CROs and external partners to deliver, consistent with a lean, hands-on early-stage culture. • Represent development sciences to senior leadership, the board, and external advisors, and contribute to portfolio-level prioritization and resourcing decisions.

🎯 Anforderungen

• PhD, PharmD, MD, or equivalent advanced degree in a relevant scientific discipline. • Minimum 12+ years of biopharmaceutical drug development experience, including significant time in technical leadership roles. • Substantial drug development experience spanning nonclinical through early clinical development, with a track record of advancing programs into and through first-in-human. • Demonstrated leadership across two or more of the following: nonclinical pharmacology/DMPK, biomarkers, clinical pharmacology, quantitative sciences, bioanalytical sciences, or research operations. • Experience operating in a lean, build-oriented, clinical-stage environment with significant reliance on CROs and external vendors. • Thrives in a hands-on, detail-oriented capacity and is energized by driving the work forward directly. • Strong record of cross-functional partnership with Clinical Development, Regulatory, and CMC.

🏖️ Vorteile

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts. • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak. • An unyielding commitment to always putting patients first. • A decentralized model that enables our program teams to focus on advancing science and helping patients. • A place where you own the vision – both for your program and your own career path. • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game. • Access to learning and development resources to help you get in the best professional shape of your life. • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs). • Flexible PTO. • Rapid career advancement for strong performers. • Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time. • Commitment to Diversity, Equity & Inclusion.