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Director of Clinical Operations
Clinical
Houston, TX, US
Pay Rate Low: 130000 | Pay Rate High: 250000
Pay Rate Low: 130000 | Pay Rate High: 250000
- Added - 05/06/2025
At Astrix, we're expanding our team to support a diverse range of clients across various industries. We're seeking talented Director of Clinical Operations to lead the planning and execution of clinical trials across all phases, with a strong focus on scaling clinical operations to support organizational growth! Our partners range from emerging biotech firms to established pharmaceutical companies, all seeking professionals who can bridge scientific insights with clinical application. Opportunities are available both remotely and on-site throughout the country!
Responsibilities:
Qualifications:
Preferred Skills:
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
#LI-DNP
Responsibilities:
- Lead and scale the clinical operations function to support the growth of the clinical pipeline from Phase I through Phase III and beyond.
- Design and implement scalable clinical trial processes, systems, and vendor strategies to support increased trial volume and complexity.
- Oversee end-to-end execution of global clinical trials, ensuring adherence to timelines, budgets, GCP, and regulatory requirements (FDA, EMA, ICH).
- Build, lead, and mentor a high-performing clinical operations team, including Clinical Trial Managers, CRAs, and support staff.
- Drive clinical program strategy in collaboration with cross-functional leaders in Clinical Development, Regulatory Affairs, Medical Affairs, and Data Management.
- Evaluate, select, and manage CROs and vendors, ensuring delivery of high-quality data and compliance with contractual obligations.
- Develop and monitor KPIs to assess performance, identify risks, and implement mitigation strategies.
- Contribute to clinical development plans, protocols, and regulatory submissions (INDs, NDAs, MAAs).
- Serve as a key operational leader during due diligence, partnership discussions, and regulatory inspections.
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field (advanced degree preferred).
- 10+ years of experience in clinical operations, with 5+ years in a leadership role.
- Demonstrated success in scaling clinical operations in a growing biotech, pharma, or CRO environment.
- Proven track record in global clinical trial management (Phase I–III), including early- and late-stage trials.
- Expertise in GCP, ICH, and international regulatory requirements.
- Strong leadership, organizational, and problem-solving skills.
- Excellent communication and cross-functional collaboration abilities.
- Ability to thrive in a fast-paced, dynamic environment with shifting priorities.
Preferred Skills:
- Experience with building or expanding internal teams, clinical systems (e.g., CTMS, eTMF, EDC), and SOPs during periods of company growth.
- Therapeutic area expertise (e.g., oncology, rare disease, CNS).
- Prior involvement in NDA/BLA/MAA preparation and regulatory interactions.
- Familiarity with decentralized or hybrid trial models and digital health tools.
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
#LI-DNP
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Director of Clinical Operations