About the Role
Aevum Zenth’s Health Sciences division is pioneering therapeutic interventions for previously untreatable genetic disorders. As Gene Therapy Clinical Director, you will own the clinical development lifecycle for our proprietary vector platform, bridging translational science, regulatory affairs, and large-scale trial operations. You will report directly to the VP of Clinical Development and collaborate with cross-functional teams spanning virology, manufacturing, data science, and global regulatory strategy.
This role requires a rare combination of clinical expertise, scientific rigor, and leadership acumen. You will shape trial architectures, ensure patient safety standards, and drive milestones that bring life-changing therapies to market.
Key Responsibilities
- Design and oversee Phase I–III clinical trials for gene therapy candidates, ensuring alignment with ICH-GCP and FDA/EMA guidelines.
- Lead cross-functional teams (clinical operations, biostatistics, medical writing, CROs) to execute study protocols on time and within budget.
- Manage regulatory submissions, IND/CTA interactions, and advisory committee meetings.
- Monitor patient safety, adverse event reporting, and data integrity across multi-site trial networks.
- Collaborate with vector engineering and manufacturing teams to align clinical endpoints with production scalability.
- Mentor junior clinical staff and foster a culture of scientific excellence and ethical trial conduct.
Qualifications & Requirements
- MD, PhD, DO, or equivalent advanced degree in molecular biology, genetics, or a related biomedical field.
- Minimum 10 years of clinical development experience, with at least 5 years in gene therapy, cell therapy, or advanced biotech.
- Proven track record of leading multi-site, global clinical trials from startup through regulatory submission.
- Deep familiarity with AAV vectors, CRISPR-Cas systems, lipid nanoparticles, or viral transduction mechanisms.
- Expertise in regulatory pathways (FDA, EMA, PMDA) and post-marketing surveillance requirements.
- Strong leadership, stakeholder management, and scientific communication skills.
Why Join Zenth Health Sciences?
Application Process
1. Submit your CV and cover letter via our portal.
2. Initial screening with our Talent Acquisition team.
3. Technical assessment & case study review.
4. Leadership panel interview with Health Sciences executives.
5. Offer & onboarding coordination.
Aevum Zenth is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Applications close on March 31, 2026.