Associate Director/Sr. Manager, Clinical Compliance Specialist
Celea Therapeutics
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Benefits offered by this job
Job summary
Celea Therapeutics is seeking an experienced, strategic, and hands-on Associate Director/Sr. Manager, Clinical Compliance Specialist to ensure adherence to GCP, SOPs, and regulatory standards across clinical programs.
This role partners with Clinical Operations, QA, Regulatory Affairs, and study teams to maintain inspection readiness and drive process excellence. In the near term, focus will be on Phase 3 readiness, SOP development, and training oversight, guiding Celea through its next growth
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Health Sciences, Pharmacy, or related field required.
- 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.
Responsibilities
- Ensure GCP, ICH, FDA, EMA, and other applicable regulations across clinical development programs and serve as a compliance resource to Clinical Operations teams.
- Monitor and assess clinical trial processes, identifying compliance risks, deviations, and inspection readiness concerns.
- Assist study teams in identifying and resolving operational compliance issues and support CAPAs and continuous improvement initiatives.
- Develop, maintain, and update clinical SOPs, work instructions, templates, and guidance documents.
- Partner with cross-functional teams to enhance quality systems and track SOP training completion.
- Support internal audits, vendor audits, and regulatory inspections.
- Support quality management system activities and continuous improvement initiatives.
Skills
Education
Tools
Job description
Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.
Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.
Rising above the status quo takes a team as strong as its science, and we hire and work by five values: accountability — owning outcomes and acting like owners; transparency — talking straight and building trust; collaboration — achieving together what no one could alone; innovation — challenging accepted ideas and taking smart risks; and passion — bringing energy and heart to the mission.
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.
- 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.
- 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.
- 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.
- 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.
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.
Actual compensation will be determined based on experience, qualifications, and location. In addition to base pay, this role is eligible for bonus and equity compensation.
Base Pay Information: $190,000 USD - $210,000 USD
Celea Therapeutics is an equal opportunity employer. We evaluate every candidate against the requirements of the role using a structured, evidence-based process, and we make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic.
For more information, visit www.celeatx.com or connect with us on Twitter @celeatx.
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