Current openings at Celea Therapeutics

Position Overview  As we prepare for our next stage of growth and clinical advancement, Celea is seeking an experienced Supply Chain Coordinator to execute study supply strategies from initial study setup activities to eventual study closeout. They will be reporting to the Associate Director Global Supply Chain and Logistics.  In the near term, their focus will be the management of packaging and distribution activities for our global Phase 3 study, ensuring on time delivery per the study supply strategy. Over time, this person will aid the growth of the Celea study portfolio, providing supply chain support for new studies as they develop. They will be instrumental in guiding Celea through its next chapter.  This position is Boston based, with 3 days on site.   Key Responsibilities  Clinical Supply Planning & Forecasting  Collaborate in the development of study supply strategies and packaging plan for assigned clinical programs  Collate information from clinical supply systems reports to assist in monitoring study progress and inventory consumption/usage.   Inventory Management & IRT/RTSM Oversight  Manage clinical inventory within IRT/RTSM systems and other supply management tools.  Perform ongoing inventory reconciliation and ensure accurate product accountability.   Monitor key supply metrics and proactively identify inventory risks or supply gaps.  Clinical Supply Operations  Execute packaging and labeling activities with CDMO per study packaging plan.   Ensure timely release and distribution of clinical supplies according to study strategy.  Vendor & External Partner Management  Serve as the day-to-day operational contact for CDMOs, Clinical Operations, logistics providers, and other supply chain partners.  Support monitoring of vendor performance against established timelines and service level expectations.  Escalate performance issues and supply risks to the Associate Director as appropriate.  Logistics & Distribution  Coordinate domestic and international clinical supply shipments.  Support import/export activities, customs documentation, and country-specific distribution requirements.  Monitor shipment status and resolve transportation issues in collaboration with logistics providers.  Manage temperature-controlled shipping requirements and ensure product integrity throughout distribution  Risk Management & Compliance  Identify supply risks and develop mitigation plans to prevent interruptions to clinical studies.  Ensure supply chain activities are conducted in compliance with GCP, GMP, GDP, and company procedures.  Participate in deviation investigations, CAPAs, and change control activities as needed.  Process Improvement  Support development, revision, and implementation of clinical supply chain SOPs and work instructions.  Identify opportunities to improve supply chain efficiency, forecasting accuracy, inventory management, and operational execution.  Build and continuously improve processes, standards, and tools — including thoughtful use of AI and automation — so the function scales with the company.  Qualifications  Required  A bachelor's degree in supply chain, science, or a healthcare related field, or equivalent on-the-job work experience is preferred  5+ years work experience with at least 3+ years of experience in Supply Chain   Demonstrated expertise in Supply chain activities, including the execution of a supply strategy for a Global Phase 2 or 3 study.   Track record of successful supply strategy execution   Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment.  Proficiency using AI tools to work smarter — curiosity about how technology can improve the quality and speed of your work.  Preferred  Experience in work within GxP Guidelines and adherence to SOPs  Experience in the setup of distribution network for Phase II and III Global Trials  Managing the supply chain aspects of IRT/IWRS builds and User Acceptance Testing  Experience in development of Clinical Supply Planning Tools  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 $75,000 – $85,000 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. 

Position Overview As we advance deupirfenidone (LYT-100) through Phase 3 toward registration, Celea is seeking an experienced, strategic, and hands-on Director, Trial Master File (TMF) to establish and maintain the standards, processes, systems, and oversight framework necessary to ensure TMFs are complete, accurate, timely, inspection-ready, and compliant with applicable regulatory requirements, ICH-GCP, organizational procedures, and industry best practices. This role provides oversight of TMF activities across the clinical development portfolio, including internal teams, CROs, functional service providers, and other external partners. The Director proactively identifies TMF risks and trends, establishes appropriate governance and escalation mechanisms, and partners with functional leadership to drive accountability and sustainable improvements in TMF quality. In the near term, your focus will be supporting Phase 3 clinical studies focusing on inspection readiness, TMF quality, and operational execution by strengthening oversight through quality reviews, risk-based monitoring, and cross-functional collaboration, while optimizing eTMF processes, enhancing vendor performance, resolving quality findings and CAPAs, and ensuring timely document management, reconciliation, and study milestone readiness, making you instrumental in guiding Celea through its next chapter. This position is open to onsite or remote work. Key Responsibilities Provide strategic leadership for the TMF program, establishing governance, standards, processes, and oversight to ensure consistent execution across the clinical development portfolio. Serve as the TMF subject matter expert, driving compliance with regulatory requirements, industry best practices, and risk-based quality management through close partnership with Clinical Operations and Quality Assurance leadership. Provide TMF oversight throughout the clinical trial lifecycle, from study start-up through closeout and archival. Monitor TMF quality metrics, risks, and compliance trends, driving escalation, remediation, and continuous improvement. Lead TMF inspection and audit readiness, supporting regulatory inspections, audits, and quality assessments. Oversee resolution of TMF findings through CAPAs, effectiveness monitoring, and process enhancements. Establish and manage TMF expectations for CROs, vendors, and external partners, including performance and risk oversight. Provide leadership for eTMF systems, TMF processes, and team development to ensure operational excellence and organizational capability. Qualifications Required Bachelor’s degree in life sciences or a related scientific discipline; an advanced degree (MS, MBA, MPH, PhD, PharmD) is preferred; equivalent experience considered. 10+ years of experience in clinical research, TMF management, Clinical Operations, or Development Operations. 5+ years of leadership experience managing TMF teams or document management functions. Experience supporting global clinical trials across multiple phases. Demonstrated experience with regulatory inspections and audit readiness programs. Experience managing CROs, vendors, and outsourced TMF activities. Deep knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements. Strong understanding of the TMF Reference Model and TMF lifecycle management. Expertise in eTMF systems (e.g., Veeva Vault, Trial Interactive, Wingspan, Florence). Knowledge of risk-based quality management and inspection readiness practices. Experience developing TMF governance frameworks, processes, metrics, and compliance programs. Strategic leadership and organizational influence. Strong people management, coaching, and talent development skills. Ability to lead cross-functional teams and drive change. Excellent stakeholder management and communication skills. Strong problem-solving, decision-making, and risk management capabilities. Preferred Experience leading TMF programs across a large clinical development portfolio. Successful track record supporting major regulatory inspections (FDA, EMA, MHRA, PMDA). Experience implementing or optimizing eTMF systems and TMF operational processes. Relevant certifications such as ACRP, SOCRA, PMP, or TMF-specific training/certifications. 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 $215,000-$245,000 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.

Position Overview As we advance deupirfenidone (LYT-100) through Phase 3 toward registration, Celea is seeking an experienced, strategic, and hands-on Associate Director, Medical Writing to own the clinical and regulatory documents that carry our science to health authorities. Reporting to the Senior Vice President, Clinical Operations and Program Strategy, you will own medical writing strategy, standards, and delivery across the portfolio — while personally authoring the highest-stakes documents, from protocols and clinical study reports through the clinical modules of our planned NDA. In the near term, your focus will be delivering Phase 3 protocols and amendments, clinical study reports, Investigator’s Brochure updates, and health authority briefing documents on timelines that protect the program’s critical path. Over time, you will build the medical writing function — templates, style standards, vendor strategy, and submission-ready processes — and serve as a core contributor to NDA authoring and readiness, making you instrumental in guiding Celea through its next chapter. This position is open to hybrid or remote work. Key Responsibilities Own medical writing for Celea’s clinical programs; deliver scientifically rigorous, regulatory-compliant documents that are accurate, consistent, and on time. Author, edit, and finalize core clinical documents — protocols and amendments, informed consent form templates, clinical study reports, Investigator’s Brochures, safety narratives, and clinical sections of the Development Safety Update Report. Lead authoring of clinical regulatory submission documents, including Module 2 summaries (2.5 Clinical Overview, 2.7 Clinical Summaries), integrated summaries of safety and efficacy, and briefing documents for FDA and international health authority meetings, in support of the planned NDA/MAA. Drive the document lifecycle end to end: build and hold authoring timelines, run comment resolution and review meetings, and shepherd documents through QC, approval, and submission-ready publishing in eCTD format. Oversee medical writing vendors and contract writers, including scope, budget, timelines, quality standards, and issue escalation. Partner cross-functionally with Clinical Development, Clinical Trial Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, and CMC to ensure documents accurately reflect the data and align with regulatory strategy and the target product profile. Ensure compliance with ICH E3 and E6(R3), FDA and EMA guidance, CONSORT, GPP, and internal SOPs; maintain document templates, style guides, and controlled terminology so quality is repeatable rather than heroic. Build and continuously improve medical writing processes, standards, and tools — including thoughtful use of AI and automation — so the function scales with the company. As we grow, recruit, mentor, and develop direct reports and contract writers. Qualifications Required Bachelor’s degree in life sciences or a related scientific discipline; an advanced degree (MS, PhD, PharmD) is preferred; equivalent experience considered. 8+ years of medical writing experience in the biotech or pharmaceutical industry (or CRO), including substantial experience authoring documents for late-phase clinical programs. Direct, hands-on contribution to at least one NDA (or BLA/MAA) submission — authoring clinical modules such as the Clinical Overview, Clinical Summaries, or integrated summaries of safety and efficacy, through filing. Demonstrated expertise authoring protocols, clinical study reports, and Investigator’s Brochures to ICH E3 and related guidance, with a working command of the CTD/eCTD structure. Ability to interpret clinical and statistical output — TLFs, SAPs, safety data — and translate it into a clear, defensible scientific narrative. Track record of delivering complex, high-visibility documents on tight timelines while managing multiple parallel workstreams and review cycles. Excellent written and oral communication skills, with the ability to lead cross-functional review discussions and drive consensus among senior stakeholders. Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment. Proficiency using AI tools to work smarter — curiosity about how technology can improve the quality and speed of your work. Preferred Experience in respiratory, pulmonology, or fibrotic disease programs, or with small-molecule products in late-stage development. Experience building or standing up a medical writing function in a small or growing clinical-stage biotech, including template and process development. Experience with regulatory publishing systems and document management platforms (e.g., Veeva Vault, PleaseReview, StartingPoint Templates), and familiarity with AMA style. 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 $195,000-$230,000 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.