Our client, a radiopharmaceutical biotech based in Texas, is looking for a Senior Director of Clinical Operations to join on as they go from pre-IND activities into the clinical stage.
Key Responsibilities:
- Provide strategic leadership and direction for the planning, execution, and oversight of all clinical operations activities across multiple therapeutic areas and phases of clinical development.
- Lead and mentor a team of clinical operations professionals to ensure high performance, professional development, and alignment with organizational goals.
- Develop and implement innovative strategies to optimize clinical trial timelines, resource allocation, and budget management while ensuring quality and compliance with regulatory standards.
- Foster strong relationships with internal stakeholders, external partners, investigational sites, and regulatory authorities to drive operational excellence and advance clinical programs.
- Oversee the selection, qualification, and management of CROs, vendors, and strategic partners to support clinical trial activities and deliverables.
- Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, data management, and biostatistics teams to achieve program milestones and objectives.
- Monitor key performance metrics, identify areas for process improvement, and implement best practices to enhance efficiency and effectiveness in clinical operations.
Qualifications:
- Advanced degree in life sciences, pharmacy, nursing, or related field; MBA or equivalent preferred.
- Minimum of 10 years of progressive leadership experience in clinical operations within the pharmaceutical, biotechnology, or CRO industry.
- Demonstrated track record of successful leadership in planning, managing, and executing global clinical trials across diverse therapeutic areas and phases of development.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements governing clinical research.
- Excellent strategic thinking, decision-making, and problem-solving skills with the ability to influence and drive change in a dynamic environment.
- Exceptional communication, interpersonal, and relationship-building skills with the ability to collaborate effectively across functional teams and external partners.
- Proven ability to manage multiple projects simultaneously, prioritize competing demands, and deliver results under tight timelines and resource constraints.
If you are a dynamic and results-driven leader looking for an exciting opportunity to make a meaningful impact in clinical research, we encourage you to apply for this senior leadership role. Join us in our mission to advance medical innovation and improve patient outcomes through transformative clinical programs.
