GondolaBio · 1 day ago
VP, Clinical Development
United States
Full-time
Remote
Director/Executive
15+ years expGondolaBio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. They are seeking a VP of Clinical Development to lead clinical programs for oligonucleotide therapeutics, ensuring the integration of clinical strategy, trial design, and regulatory engagement. The role requires collaboration with multidisciplinary teams and external partners to drive clinical trials from IND submission to proof-of-concept.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Program ownership: Serve as overall clinical program owner for oligonucleotide therapeutic programs, driving them from IND submission through clinical proof-of-concept, pivotal studies, and regulatory engagement
Clinical strategy and development: Define and lead the clinical development strategy for programs targeting PNS and other relevant indications. Ensure the integration of translational insights, biomarker strategies, and regulatory considerations into cohesive clinical plans
Trial design and execution: Design and oversee early- and late-stage clinical trials (IIT, Phase 1–3) for siRNA therapeutics. Ensure clinical protocols are scientifically rigorous, operationally feasible, and aligned with regulatory and ethical standards
Translational integration: Partner with preclinical and translational biology teams to connect mechanistic and biomarker data with clinical endpoints. Translate preclinical findings into human studies to enable rational dose selection, patient stratification, and early efficacy assessment
Clinical operations leadership: Oversee cross-functional execution of clinical trials, ensuring alignment across clinical operations, biostatistics, regulatory, and CMC functions. Set milestones and drive data-driven decision-making to meet program timelines
Global site strategy: Guide site selection and operational planning across both U.S. and international locations. Ensure successful execution of trials in diverse geographies, maintaining compliance with global regulatory and ethical standards
Regulatory and medical affairs interface: Lead preparation and review of clinical sections of INDs, Investigator’s Brochures, and regulatory briefing documents. Represent clinical programs in regulatory interactions and advisory meetings
External collaboration: Build and manage productive relationships with CROs, investigators, and KOLs to strengthen program execution and strategic insight. Evaluate and manage academic and industry partnerships to advance clinical programs efficiently
Cross-functional leadership: Inspire and lead multidisciplinary teams, ensuring alignment and collaboration across R&D, clinical, and corporate functions. Foster a culture of transparency, scientific integrity, and urgency in execution
Qualification
Required
You are an experienced clinical development leader with deep expertise in peripheral nervous system (PNS) disorders and a proven record of success in designing and executing oligonucleotide-based clinical trials (siRNA, ASO)
You thrive in dynamic, cross-functional settings and are driven by translating scientific breakthroughs into meaningful patient outcomes
You combine strategic clinical insight with operational discipline and inspire multidisciplinary teams to deliver high-quality, data-driven results
Program ownership: Serve as overall clinical program owner for oligonucleotide therapeutic programs, driving them from IND submission through clinical proof-of-concept, pivotal studies, and regulatory engagement
Clinical strategy and development: Define and lead the clinical development strategy for programs targeting PNS and other relevant indications. Ensure the integration of translational insights, biomarker strategies, and regulatory considerations into cohesive clinical plans
Trial design and execution: Design and oversee early- and late-stage clinical trials (IIT, Phase 1–3) for siRNA therapeutics. Ensure clinical protocols are scientifically rigorous, operationally feasible, and aligned with regulatory and ethical standards
Translational integration: Partner with preclinical and translational biology teams to connect mechanistic and biomarker data with clinical endpoints. Translate preclinical findings into human studies to enable rational dose selection, patient stratification, and early efficacy assessment
Clinical operations leadership: Oversee cross-functional execution of clinical trials, ensuring alignment across clinical operations, biostatistics, regulatory, and CMC functions. Set milestones and drive data-driven decision-making to meet program timelines
Global site strategy: Guide site selection and operational planning across both U.S. and international locations. Ensure successful execution of trials in diverse geographies, maintaining compliance with global regulatory and ethical standards
Regulatory and medical affairs interface: Lead preparation and review of clinical sections of INDs, Investigator's Brochures, and regulatory briefing documents. Represent clinical programs in regulatory interactions and advisory meetings
External collaboration: Build and manage productive relationships with CROs, investigators, and KOLs to strengthen program execution and strategic insight. Evaluate and manage academic and industry partnerships to advance clinical programs efficiently
Cross-functional leadership: Inspire and lead multidisciplinary teams, ensuring alignment and collaboration across R&D, clinical, and corporate functions. Foster a culture of transparency, scientific integrity, and urgency in execution
Preferred
M.D., M.D./Ph.D., or equivalent clinical degree in neurology, pharmacology, or related biomedical discipline
15+ years of experience in clinical development, with at least 5 years in a senior leadership role
Proven success advancing oligonucleotide or other genetic medicine programs from IND through proof-of-concept and pivotal clinical studies
Deep expertise in clinical trial design, execution, and interpretation within peripheral nervous system (PNS) indications
Strong background in translational strategy, biomarker integration, and clinical pharmacology
Demonstrated ability to lead cross-functional clinical programs through regulatory interactions and global development
Regulatory-facing experience strongly preferred
Experience with siRNA or antisense oligonucleotide (ASO) therapeutic modalities
Prior involvement with international clinical sites
Familiarity with nucleic acid therapeutic delivery approaches and biomarkers for target engagement
Track record of building and scaling clinical development organizations in a fast-paced biotech environment
Experience interfacing with academic collaborators, CROs, and key opinion leaders in neurology and rare disease
Benefits
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
Partnerships with leading institutions
Commitment to Diversity, Equity & Inclusion
Company
GondolaBio
GondolaBio researches, develops and manufactures pharmaceutical products. It is a sub-organization of BridgeBio.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$300M2024-08-16Series Unknown· $300M
Leadership Team
J
James Li
President
Recent News
Company data provided by crunchbase