Senior Clinical Trial Manager

Cyllene Therapeutics is a clinical-stage biotechnology company developing next-generation DNA medicines for the treatment of prevalent chronic and severe neurological disorders. We have developed our proprietary HERMES (Herpes-based Modular Expression System) platform that utilizes non-replicative herpes simplex virus type 1 (nrHSV-1) vectors engineered to deliver site-specific long-lasting therapies directly to target neurons while avoiding systemic exposure. Our lead product candidate, EG110A, has shown favorable safety and efficacy interim results in our first-in-human trial currently ongoing in four U.S. sites in patients with neurogenic detrusor overactivity (NDO)-related incontinence following spinal cord injury.

We believe our HERMES platform has the potential to overcome key limitations of conventional gene therapy approaches, including limited payload capacity, immunogenicity, off-target effects, challenges associated with repeat administration and high manufacturing costs, thereby providing us with potential opportunities to grow our pipeline of product candidates. Our second product candidate, EG142A, has now demonstrated encouraging preclinical activity in a series of animal models in different forms of chronic pain.

Job Description:

We are seeking a Senior Clinical Trial Manager to lead the day-to-day execution of a clinical study in neurogenic detrusor overactivity (NDO) for a novel gene-therapy program.

The Senior CTM will bring together clinical sites, contract research organizations (CROs), vendors, and internal members to deliver a well-run study that drives clear actionable decisions.

The Senior CTM will act as the primary operational point of contact for the assigned study, driving cross-functional alignment, anticipating challenges, and proposing solutions to ensure study objectives are achieved.

Main responsibilities include:

• Lead the development, implementation, and ongoing management of study operational plans, timelines, budgets, and risk mitigation strategies in collaboration with the CRO, ensuring delivery against agreed milestones, quality standards, and financial objectives.
• Lead joint CRO and Sponsor meetings with respect to the study and vendor calls, set clear deliverables, reviews performance, and resolve issues promptly.
• Collaborate on site selection, oversee startup, enrolment, monitoring, and retention.
• Identify trends, risks, and operational issues through the study metrics and status reports, site metrics, clinical data, and other study-level information, and develop appropriate corrective and preventive actions.
• Reviews the monitoring reports to oversee the CRO activities
• Works collaboratively with internal colleagues, including Regulatory and CMC, on study set up and progress.
• Partner with internal and external colleagues across Clinical Development, safety, regulatory, data management, biostatistics, and product-supply teams to keep study activities aligned.
• Maintains direct contact to investigators and site coordinators on the study as appropriate
• Conduct co-monitoring and/or Sponsor oversight visits to evaluate CRA and/or site performance, monitoring quality, protocol compliance, source data verification practices, and overall study conduct.
• Contribute to the development and review of study related documentation and systems, including but not limited to Lab and Pharmacy manuals, ICF, Patient Diary, CRFs, EDC, IVRS, Edit checks, Data Management Plan, and Monitoring Plan.
• Partner with CMC function, Clinical Supply, and relevant technical teams to ensure site readiness for investigational product handling, storage, preparation, administration, accountability, and traceability.
• Maintain oversight of protocol deviations in collaboration with the CRO and Data Management, data quality, and inspection-ready trial records.
• Discuss study progress, forecasts, risks, and proposed solutions with program leadership.

Key Qualifications:

Education: Bachelor’s or Master’s degree in Life sciences, nursing, or related field, or equivalent clinical research experience.

Professional experience:

• At least 7 years of clinical research experience, including 5 years managing clinical trials in a Sponsor or CRO setting.
• Experience working in a biotech or pharmaceutical Sponsor environment, preferably within a small to mid-sized organization.
• Experience leading multicenter studies and managing CROs, vendors, budgets, and cross-functional teams.
• Working knowledge of Good Clinical Practice, clinical trial regulations, and Sponsor oversight responsibilities.
• Ability to work in a fast-paced environment.
• Displays strong judgment, organization, communication, and problem-solving skills.
• Experience with gene therapy or biologics, or other complex investigational products.
• Experience in urology, neuro-urology, or neurology studies.
• Experience with phase 2-3 trials and long-term follow-up programs.
• Experience preparing for regulatory inspections or supporting clinical sections of submissions.

Soft skills:

• Excellent cross-functional collaboration & communication skills
• Collaborative approach.
• Problem-Solving & Proactive Risk Management
• Adaptability & Prioritization

Travel: Approximately 10/15% as needed for site visits and study meetings.

Languages: English (spoken and written)

Cyllene Therapeutics is an equal opportunity employer. We welcome applicants of all backgrounds and do not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veterans status or any other protected characteristic.