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Creating new and meaningful medicines for patients with genetic diseases
Senior Director – Clinical Development
Location
California
Posted
94 days ago
Salary
$336K - $380K / year
Seniority
Senior
Job Description
Senior Director – Clinical Development
GondolaBio
• 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 • Define and lead the clinical development strategy for programs targeting PNS and other relevant indications • Design and oversee early- and late-stage clinical trials (IIT, Phase 1–3) for siRNA therapeutics • Partner with preclinical and translational biology teams to connect mechanistic and biomarker data with clinical endpoints • Oversee cross-functional execution of clinical trials, ensuring alignment across clinical operations, biostatistics, regulatory, and CMC functions • Guide site selection and operational planning across both U.S. and international locations • Lead preparation and review of clinical sections of INDs, Investigator’s Brochures, and regulatory briefing documents • Build and manage productive relationships with CROs, investigators, and KOLs • Inspire and lead multidisciplinary teams, ensuring alignment and collaboration across R&D, clinical, and corporate functions
Job Requirements
- M.D., M.D./Ph.D., or equivalent clinical degree in neurology, pharmacology, or related biomedical discipline
- 10+ 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 is a nice-to-have
- Prior involvement with international clinical sites is a nice-to-have
- Familiarity with nucleic acid therapeutic delivery approaches and biomarkers for target engagement is a nice-to-have
- Track record of building and scaling clinical development organizations in a fast-paced biotech environment is a nice-to-have
- Experience interfacing with academic collaborators, CROs, and key opinion leaders in neurology and rare disease is a nice-to-have
Benefits
- Patient Days, where we hear directly from individuals living with conditions we seek to impact
- 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 de-centralized 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
- 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
- Partnerships with leading institutions
- Commitment to Diversity, Equity & Inclusion
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