Director Clinical Program Operations

As we advance deupirfenidone (LYT-100) through Phase 3 toward registration, Celea is seeking an experienced, strategic, and hands-on Director, Clinical Program Operations to oversee the operational execution, financial management, and regulatory readiness of clinical development programs to support regulatory approval and commercialization. This role serves as a key cross-functional partner across Clinical Operations, Clinical Development, Regulatory Affairs, Finance, Biostatistics, Data Management, Medical Affairs, Quality, and external vendors to ensure programs are delivered on time, within budget, and in compliance with applicable regulations and company objectives. The Director reports to the Senior Vice President of Clinical Operations and Program Strategy to develop strategic development plans that support the LYT-100 program and Celea.

In the near term, your focus will be to develop an integrated development plan for LYT-100 and to support Phase 3 and other registrational clinical studies making you instrumental in guiding Celea through its next chapter.

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

Key Responsibilities

• Lead end-to-end planning, execution, governance, and delivery of global clinical development programs, ensuring alignment with strategic objectives, timelines, budgets, and key development milestones.

• Partner with Clinical Development, Clinical Operations, Medical Writing, Regulatory Affairs, and cross-functional stakeholders to translate development strategies into integrated, executable program plans.

• Monitor program performance through KPIs, dashboards, governance processes, and risk management frameworks, proactively identifying and mitigating operational, financial, regulatory, and execution risks.

• Develop and manage multi-million-dollar clinical program and portfolio budgets, partnering with Finance on forecasting, long-range planning, resource allocation, scenario analyses, and business case development.

• Oversee Medical Writing, Trial Master File (TMF), CROs, vendors, and strategic partners to ensure high-quality execution, inspection readiness, and achievement of program objectives.

• Lead vendor management activities, including vendor selection, contract negotiations, performance oversight, relationship management, and optimization of outsourcing strategies.

• Collaborate with Regulatory Affairs to support global regulatory strategies, health authority interactions, and regulatory submissions while ensuring compliance with GCP, ICH, FDA, EMA, and other applicable requirements.

• Drive cross-functional governance, executive communications, resource and capacity planning, and continuous improvement initiatives, providing leadership updates and enabling effective decision-making across the development portfolio.

Qualifications

Required

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

• Advanced degree preferred (MBA, MPH, PharmD, PhD, MS, or equivalent).

• 12+ years of progressive experience in biotechnology, pharmaceutical, or clinical research organizations.

• 8+ years of experience leading cross-functional clinical development programs.

• Demonstrated experience managing clinical program budgets exceeding $25M annually.

• Experience supporting regulatory submissions and health authority interactions.

• Deep expertise in clinical development, including global trial design and execution, drug development strategy, and management of multi-regional clinical programs.

• Strong financial and strategic acumen with experience in budgeting, forecasting, portfolio management, resource planning, investment evaluation, and balancing scientific, operational, regulatory, and financial priorities.

• Proven leadership and regulatory expertise, including knowledge of FDA, EMA, and ICH-GCP requirements; ability to lead cross-functional teams, influence stakeholders, drive governance, manage risk, and communicate effectively with executive leadership

Preferred

• Experience in pulmonary asset development

• MBA or advanced business training combined with clinical development experience.

• PMP, PgMP, or similar project/program management certification.

• Experience in oncology, rare disease, immunology, neuroscience, or other specialized therapeutic areas.

• Experience supporting product approvals and launch readiness activities.

• Background in both sponsor organizations and CRO environments.

• Familiarity with portfolio planning software, financial systems, and clinical trial management platforms.

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 $220,000 — $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.

Base Pay Information 220000 - 245000 USD