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Director of Clinical Operations
Southwest Florida, FL · Biotech/PharmaceuticalWe are partnering with a rapidly growing, pre-revenue biotech company, funded by ultra-high-net-worth individuals with a mission to revolutionize cancer treatment, in their search for a Director of Clinical Operations. This is an exceptional opportunity to join a lean, agile, and mission-driven organization poised for astounding breakthroughs in oncology. The company is in a very stable and secure financial position, with a long-term vision to transform cancer care.
Title: Director of Clinical Operations
Location: Southwest Florida | Relocation Provided
Key Notes:
Title: Director of Clinical Operations
Location: Southwest Florida | Relocation Provided
Key Notes:
- Join a lean, agile, and highly committed team dedicated to developing innovative approaches to cancer treatment.
- You will oversee an active global mid-stage clinical trial and prepare for upcoming early- and late-phase studies. The company’s novel technology enables highly targeted approaches with rapid systemic clearance, supported by strong preclinical data.
- Work alongside visionary leaders in a robustly funded, strategically focused organization.
- Enjoy a competitive salary, comprehensive benefits, and employee incentive stock options with high projected value.
- Strategic Oversight: Develop and implement clinical operations strategies, provide leadership in clinical development planning, and drive operational excellence.
- Clinical Trial Management: Oversee the planning, execution, and delivery of clinical trials, managing timelines, budgets, and resources across Phases I-IV. Be the primary point of contact for clinical trial sites and manage all aspects from study startup to close-out. This includes oversight of eTMF systems, eCRF validation, and coordination with regulatory for data submissions.
- Team Leadership: Build, lead, and mentor a high-performing Clinical Operations team, currently comprising US employees and offshore contractors in the Philippines and Latin America.
- Vendor and Budget Oversight: Maintain relationships with CROs and other vendors, ensuring effective resource use while the majority of operations remain in-house.
- Regulatory and Quality Compliance: Ensure adherence to GCP, ICH, FDA, EMA, and global regulations. Support regulatory submissions with critical clinical operations data and documentation.
- Cross-Functional Collaboration: Work closely with Clinical Development, Regulatory, Data Management, Biostatistics, and Pharmacovigilance teams, actively shaping overall clinical strategy.
- At least 10 years of experience in clinical research with a minimum of 5 years in a leadership role within biotech or pharma.
- Proven ability to lead global trials through all phases, including familiarity with FDA, EMA, and other international agencies.
- Experience managing both insourced and outsourced clinical trial models.
- Strong project, vendor, and budget management skills.
- Excellent leadership, communication, and problem-solving abilities.
- Comfortable in a fast-paced, matrixed environment with an agile mindset.
- Oncology experience, prior involvement in NDA/MAA submissions, regulatory inspections, and expertise with eTMF, CTMS, or EDC systems.
- Up to 20%, including international travel.
- Competitive base salary and discretionary bonuses.
- Employee incentive stock options with significant upside potential.
- Comprehensive health, dental, and vision insurance.
- 401(k) with automatic safe harbor contribution.
- Modest relocation support.