Position Title: Senior Clinical Trial Manager
Location: Remote (Corporate Headquarters: Fort Lee, NJ)
Department: Clinical
Classification: Full-Time, Exempt, Salaried
Reports to: Chief Operating Officer
About Us:
Mezzion Pharmaceuticals is a clinical-stage pharmaceutical company dedicated to addressing rare diseases. We are currently focused on developing JURVIGO® (udenafil), which has the potential to become the first approved chronic treatment for approximately 70,000 individuals living with single-ventricle congenital heart disease who have undergone Fontan surgery ( Fontan ).
JURVIGO® (udenafil), is a highly selective, oral, and potent phosphodiesterase type 5 inhibitor (PDE5i). With a life expectancy of only 35–45 years, the Fontan population currently has no approved pharmacological treatments. JURVIGO® is designed to enhance cardiovascular physiology and delay disease progression in these patients.
Mezzion is actively enrolling Fontan patients into FUEL-2, a pivotal phase 3 confirmatory trial. As the largest Fontan trial ever undertaken, FUEL-2 spans multiple sites across the United States, Europe, and South Korea.
Position Summary:
We are seeking a Senior Clinical Trial Manager to lead all aspects of clinical trial operations for late-stage studies. This pivotal role involves managing Clinical Research Organizations (CROs) and ensuring that timelines, quality, and budgetary objectives are achieved. Reporting directly to the Chief Operating Officer, the Senior Clinical Trial Manager will play a strategic and hands-on role in shaping our clinical program.
Key Responsibilities:
- Oversee all operational aspects of Mezzion's phase 3 clinical programs, including direct management of CROs to ensure timelines and deliverables are met.
- Provide strategic guidance in the evaluation and selection of CROs and clinical vendors.
- Lead and manage Clinical Operations to align with quality standards, resource needs, and budget constraints.
- Establish and monitor performance metrics to ensure successful execution of clinical trials.
- Integrate clinical operations expertise into development plans, protocols, and study designs.
- Collaborate with cross-functional teams, project leads, and internal stakeholders.
- Partner with Clinical Quality Assurance to plan and implement quality checks for compliance with SOPs, ICH-GCP guidelines, and regulatory standards.
- Support regulatory submissions and participate in interactions with agencies such as the FDA and EMA.
- Stay informed about competitive clinical practices and regulatory trends to inform development plans.
Qualifications:
Education:
- Bachelor's Degree in Nursing (BSN), Health Administration, Life Sciences (Biology, Chemistry, etc…), Public Health and/or Business Administration.
- Master's Degree (e.g. MBA, MS or MSN) preferred
Experience:
- 5-10 years of clinical research experience, including direct project management of phase 3 trials and CRO oversight.
- Expertise in clinical development operations, strategic planning, and late-stage trial execution.
- Experience developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, and other regulatory documents.
- Background in rare diseases, congenital heart disease, or exercise physiology highly desirable.
- Proficiency in clinical data management and pharmacovigilance is an advantage.
Skills:
- Proven ability to manage CROs and lead cross-functional teams.
- Exceptional problem-solving, organizational, and communication skills.
- Thorough knowledge of FDA regulations, ICH Guidelines, and clinical research standards.
- Ability to engage with clinical trial sites to optimize enrollment.
- Self-motivated, results-driven, and adaptable to dynamic environments.
Work Environment:
- High-growth, fast-paced biotech setting requiring adaptability and initiative.
- Up to 50% travel, primarily domestic, with occasional international travel.
Mezzion Pharmaceuticals is committed to fostering a collaborative and inclusive work environment. This job description reflects the general scope of responsibilities and may evolve to meet organizational needs.