GondolaBio logo
GondolaBio

Creating new and meaningful medicines for patients with genetic diseases

Senior Director – Clinical Development

DirectorDirectorFull TimeRemoteSeniorTeam 11-50Since 2024Company SiteLinkedIn

Location

California

Posted

1 day ago

Salary

$336K - $380K / year

Seniority

Senior

Postgraduate Degree10 yrs expEnglish

Job Description

• 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

Related Categories

Related Job Pages

More Director Jobs

Inovalon logo

Senior Director, Commercial and Market Access Analytics

Inovalon

Empowering data-driven healthcare for payers, providers, pharmacies, and life sciences organizations.

Director1 day ago
Full TimeRemoteTeam 1,001-5,000H1B Sponsor

Senior Director leading CMAA insights generation at Inovalon

United States
$170.9K - $220K / year
Full TimeRemoteTeam 1,001-5,000

Associate Director, Pricing managing pricing strategy for Crane Authentication

Pennsylvania
Director1 day ago
Full TimeRemoteTeam 5,001-10,000Since 1993H1B Sponsor

Director of Alliance Management leading customer projects at Just-Evotec

Connecticut + 3 moreAll locations: Connecticut, New Jersey, Massachusetts, Washington
$150K - $202K / year
Full TimeRemoteTeam 10,001

This role involves supervising, guiding, and leading Good Clinical Practice (GCP) Audit Programs, which includes managing direct reports and supporting departmental goal execution. Responsibilities also cover overseeing risk-based quality auditing activities and applying knowledge of FDA, EU regulations, and ICH guidance documents.

United States + 1 moreAll locations: United States, United Kingdom
$157K - $256K / year