Clinical Research Director

Southwest Womens Oncology Inc•Albuquerque, NM

48d•Onsite

About The Position

The Clinical Research Director will build and lead Southwest Women's Oncology’s clinical research program, developing its strategy, infrastructure, team, and external relationships. The role will establish a rigorous, patient-centered program aligned with organizational goals and clinical priorities, working with gynecologic oncology Principal Investigators, sponsors, CROs, cooperative research groups, research staff, executive leadership, and regulatory bodies. The director will lead clinical trials through feasibility, start-up, recruitment, execution, monitoring, and close-out; oversee budgets, billing compliance, financial performance, and reporting; and ensure compliance with ICH-GCP, FDA, NIH, IRB, and institutional requirements. The role also includes developing SOPs, hiring and developing research staff, supporting investigators, maintaining sponsor and stakeholder relationships, and overseeing audit readiness and continuous improvement. This is a full-time, on-site position at the Albuquerque, New Mexico office. The role reports no specific supervisor in the posting. Compensation includes a competitive salary and the listed benefits.

Requirements

Bachelor's degree in a health science, life science, or related field.
10+ years of clinical research experience, including 5+ years in a leadership or director-level role.
Proven ability to build, scale, and manage a clinical research program or site.
Deep understanding of ICH-GCP, FDA, NIH, and clinical research compliance standards.
Experience coordinating Phase II–IV therapeutic drug or device trials.
Strong business and financial acumen, including experience with clinical research budgeting, billing compliance, and contract management.
Excellent communication, relationship management, and negotiation skills.

Nice To Haves

Master's degree in a relevant field.
Prior experience leading oncology or gynecologic oncology clinical trials.
CCRP, CCRC, or equivalent certification.
Established relationships with pharmaceutical sponsors, CROs, or cooperative research groups.

Responsibilities

Build, scale, and manage the clinical research vertical, including its long-term strategy, infrastructure, and resourcing plans.
Partner with the Executive Team to align research strategy with organizational goals and clinical priorities.
Evaluate research opportunities and develop business cases for study selection, site expansion, and external partnerships.
Lead the full clinical trial lifecycle, including feasibility, start-up, recruitment, execution, monitoring, and close-out.
Oversee study budgets, billing compliance, financial performance, reporting, and forecasting.
Maintain compliance with ICH-GCP, FDA, NIH, IRB, and institutional requirements.
Develop, implement, and refine Standard Operating Procedures for research operations.
Hire, onboard, mentor, and manage Clinical Research Coordinators, data specialists, and research support staff.
Build a culture of excellence, accountability, scientific integrity, and continuous improvement.
Oversee performance management and professional development for direct reports.
Serve as the primary liaison for pharmaceutical sponsors, CROs, investigators, and regulatory agencies.
Support Principal Investigators in protocol execution and ensure appropriate documentation and data integrity.
Represent SWWO in research networks, professional associations, and industry conferences.
Ensure research is conducted ethically and complies with institutional, state, and federal regulations.
Oversee audit readiness, inspection preparation, and corrective action processes.
Identify and implement process improvements and emerging technologies to optimize research operations.