Associate Director/Sr. Manager, Clinical Compliance Specialist

As we advance deupirfenidone (LYT-100) through Phase 3 toward registration, Celea is seeking an experienced, strategic, and hands-on Associate Director/Sr. Manager, Clinical Compliance Specialist to support and maintain compliance within the clinical research and development organization by ensuring adherence to applicable regulations, Good Clinical Practice (GCP), company Standard Operating Procedures (SOPs), and industry standards. This role partners closely with Clinical Operations, Quality Assurance, Regulatory Affairs, Clinical Development, and study teams to promote inspection readiness, process consistency, and operational excellence across clinical programs. The Associate Director/Sr. Manager proactively identifies compliance risks, supports process improvements, and fosters a culture of quality throughout the organization. 

In the near term, your focus will be supporting Phase 3 clinical studies focusing on inspection readiness, SOP development, and training oversight making you instrumental in guiding Celea through its next chapter. 

This position is open to remote or hybrid (Boston) candidates. 

Key Responsibilities 

• Ensure compliance with GCP, ICH, FDA, EMA, and other applicable regulations across clinical development programs and serve as a compliance resource to Clinical Operations teams during study startup, conduct, and closeout. 

• Monitor and assess clinical trial processes and documentation, identifying, evaluating, and escalating compliance risks, deviations, and inspection readiness concerns. 

• Assist study teams in identifying and resolving operational compliance issues and support the implementation of corrective and preventive actions (CAPAs) and continuous compliance improvement initiatives. 

• Develop, maintain, and periodically review and update clinical SOPs, work instructions, templates, and guidance documents to ensure alignment with current regulations, industry standards, and organizational needs. 

• Partner with cross-functional teams to enhance quality systems and operational processes while tracking SOP training completion and maintaining compliance records. 

• Support internal audits, vendor audits, and regulatory inspections. 

• Support quality management system activities and continuous improvement initiatives. 

Qualifications 

Required 

• Bachelor's degree in Life Sciences, Nursing, Health Sciences, Pharmacy, or related field required. 

• Advanced degree preferred. 

• 3-7 years of experience in clinical research, clinical operations, quality assurance, or clinical compliance. 

• Experience working in pharmaceutical, biotechnology, medical device, or CRO environments. 

• Knowledge of global clinical trial regulations and compliance requirements and ability to translate requirements into practical operational guidance. 

• Experience supporting SOP development and quality system processes. 

• Working knowledge of clinical trial lifecycle and study execution and understanding of site management, monitoring, TMF requirements, and vendor oversight. 

• Familiarity with audit and inspection activities. 

• Strong organizational and documentation skills. 

• Strong training and presentation capabilities. 

Preferred 

• Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or equivalent certification. 

• Experience supporting regulatory inspections (FDA, EMA, MHRA, PMDA, or other health authorities). 

• Experience with electronic quality management systems (eQMS), document management systems, and clinical trial systems. 

• Knowledge of risk-based quality management (RBQM) principles. 

• Experience working with global clinical trials and outsourced service providers. 

Why Join Celea Therapeutics 

• Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases. 

• Shape the foundation of a Phase 3 biotech poised for significant growth. 

• Collaborate with a passionate, mission-driven leadership team. 

• Competitive compensation and equity package. 

Compensation 

Transparency is one of our values, and that includes how we pay. The anticipated salary range for this role is $190,000 — $210,000 plus bonus and equity. Where an offer lands within the range reflects the candidate’s experience, skills, and internal equity — and we welcome open conversations about compensation from the first call, so there are no surprises at the offer stage.