Remote Director, Global Clinical Program Operations

Celea Therapeutics

Boston (MA)

Hybrid

USD 220,000 - 245,000

Full time

7 days ago
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Benefits offered by this job

Equity package
Bonus eligibility
Remote/hybrid work options
Competitive compensation

Job summary

Celea Therapeutics is seeking an experienced Director of Clinical Program Operations to oversee the operational execution, financial management, and regulatory readiness of Phase 3 trials for LYT-100. You will partner across Clinical Operations, Regulatory Affairs, Finance, and Biomedical teams to ensure programs are delivered on time, within budget, and in compliance with FDA/ICH guidelines.

The role offers remote and hybrid (Boston) options and requires deep clinical development expertise,

Qualifications

  • Bachelor’s degree required in life sciences or related field.
  • Advanced degree preferred (MBA, MPH, PharmD, PhD, MS).
  • 12+ years of experience in biotech, pharmaceutical, or CRO.
  • 8+ years leading cross-functional clinical programs.
  • Experience managing annual budgets exceeding $25M.
  • Experience supporting regulatory submissions and health authority interactions.
  • Strong leadership and cross-functional influence and communication.

Responsibilities

  • Lead end-to-end planning, execution, governance, and delivery of global clinical development programs.
  • Partner with cross-functional teams to translate strategies into executable program plans.
  • Monitor KPIs and risk management to mitigate operational, regulatory, and financial risks.
  • Develop and manage multi-million-dollar program budgets and forecasting with Finance.
  • Oversee TMF, CROs, vendors, and external partners to ensure inspection readiness.
  • Lead vendor management: selection, negotiations, performance oversight.

Skills

Strategic leadership
Clinical program management
Budgeting & forecasting
Regulatory submissions
Vendor management
Cross-functional collaboration
Communication
Financial acumen

Education

Bachelor's degree in Life Sciences, Pharmacy, Nursing, Business, Finance, or related field
MBA/PhD/PharmD/MS preferred

Tools

CTMS
Portfolio planning software
Financial systems

Job description

Celea Therapeutics is seeking an experienced Director of Clinical Program Operations to oversee the operational execution, financial management, and regulatory readiness of Phase 3 trials for LYT-100. You will partner across Clinical Operations, Regulatory Affairs, Finance, and Biomedical teams to ensure programs are delivered on time, within budget, and in compliance with FDA/ICH guidelines.

The role offers remote and hybrid (Boston) options and requires deep clinical development expertise,

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