Vice President, Development

This is a fully remote position, open to applicants in California.

📋 Description

• Provide strategic scientific and operational leadership throughout the development sciences functions that progress genetic disease programs from candidate selection to first-in-human and early clinical development, including:

• Nonclinical Pharmacology & DMPK Sciences • Lead nonclinical PK/PD strategy encompassing target engagement, pharmacodynamic response, and efficacy.

• Supervise in vitro and in vivo ADME and DMPK characterization to aid in candidate selection and IND-enabling packages.

• Biomarker Sciences & Development • Spearhead biomarker identification as well as the nonclinical-to-clinical biomarker strategy and execution.

• Propel clinical biomarker qualifications to establish proof of mechanism and proof of concept.

• Clinical Pharmacology & Early Clinical Development • Oversee early clinical sciences and development strategy from first-in-human through Phase 2.

• Direct clinical pharmacology efforts, including Phase 1 healthy-volunteer and special-population studies.

• Quantitative Sciences • Lead initiatives across data analytics, pharmacometrics, biostatistics, and data management to inform dose selection and program decisions.

• Research Operations • Manage nonclinical and translational study execution along with vendor management.

• Oversee clinical pharmacology study execution and associated vendor relationships.

• Bioanalytical Sciences • Guide bioanalytical assay development for PK, biomarkers, and immunogenicity.

• Supervise both nonclinical and clinical bioanalytical operations.

• Cross-Functional Leadership • Collaborate closely with Clinical Development, Global Regulatory Affairs, CMC, and Research to produce integrated development plans and regulatory submissions (pre-IND, IND, FIH, Phase 1/2).

• Personally lead the technical work across these functions while remaining close to the science and data, utilizing CROs and external partners to ensure alignment with a lean, hands-on early-stage culture.

• Represent development sciences to senior leadership, the board, and external advisors, contributing to portfolio-level prioritization and resource allocation decisions.

⛳️ Requirements

• PhD, PharmD, MD, or equivalent advanced degree in a relevant scientific field.

• At least 12+ years of experience in biopharmaceutical drug development, including significant time in technical leadership roles.

• Extensive drug development experience covering nonclinical to early clinical stages, with a proven record of advancing programs into and through first-in-human.

• Demonstrated leadership in two or more of the following areas: nonclinical pharmacology/DMPK, biomarkers, clinical pharmacology, quantitative sciences, bioanalytical sciences, or research operations.

• Experience in a lean, build-oriented, clinical-stage environment with considerable reliance on CROs and external vendors.

• Excels in a hands-on, detail-oriented role and is motivated by driving work directly.

• Strong history of cross-functional collaboration with Clinical Development, Regulatory, and CMC.

🏝️ Benefits

• Patient Days, where we are privileged to hear directly from individuals living with the conditions we aim to impact, learning how we can enhance our efforts throughout the year.

• A culture driven by our values: prioritize patients, think independently, embrace radical transparency, value every minute, and let science lead the way.

• An unwavering commitment to consistently putting patients first.

• A decentralized model that empowers our program teams to concentrate on advancing science and assisting patients.

• A workplace where you take ownership of the vision – both for your program and your own career trajectory.

• A collaborative, fast-paced, data-driven environment that motivates us to consistently perform at our highest level.

• Access to learning and development resources to help you achieve your best professional self.

• Comprehensive and competitive compensation & benefits package (Base salary, Performance Bonus, Equity, health, welfare & retirement programs).

• Flexible PTO.

• Opportunities for rapid career advancement for high performers.

• Potential to engage in multiple GondolaBio Pharma programs across various therapeutic areas over time.

• A commitment to Diversity, Equity & Inclusion.