Clinical Research Director

Southwest Womens Oncology/Optimum•Albuquerque, NM

4d•Onsite

About The Position

Southwest Women's Oncology is building a clinical research program commensurate with its clinical reputation. The Clinical Research Director will lead this effort by building the infrastructure, developing the team, establishing partnerships, and setting the standard for oncology research. This role offers a rare opportunity to build a program from the ground up within an organization committed to clinical excellence and physician leadership. The company values attitude and aptitude, with a focus on growth and development. Southwest Women's Oncology (SWWO) is New Mexico's leading gynecologic oncology practice. In conjunction with Optimum Human and Optimum Infusion, SWWO operates as a single integrated platform focused on delivering new possibilities in medical care, human performance, and health. The Clinical Research Director will design and lead the clinical research vertical, establishing the strategy, systems, team, and relationships that will define the program's future. This role involves working at the intersection of scientific rigor, operational excellence, and patient impact, partnering with physicians, sponsors, CROs, cooperative groups, research staff, executive leadership, regulatory bodies, and the broader Optimum platform. The position offers the authority, resources, and leadership support to build a program that can significantly impact patients' lives.

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 within SWWO, developing long-term strategy, infrastructure, and resourcing plans.
Partner with the Executive Team to align research strategy with organizational goals and clinical priorities.
Evaluate new research opportunities and develop business cases for study selection, site expansion, and external partnerships.
Lead the full lifecycle of clinical trials-feasibility, start-up, recruitment, execution, monitoring, and close-out.
Oversee study budgets, billing compliance, and financial performance; ensure accurate reporting and forecasting.
Maintain compliance with ICH-GCP, FDA, NIH, IRB, and all institutional requirements.
Develop, implement, and continuously refine Standard Operating Procedures (SOPs) for research operations.
Hire, onboard, mentor, and manage a team of Clinical Research Coordinators, data specialists, and research support staff.
Build a culture of excellence, accountability, scientific integrity, and continuous improvement within the research team.
Oversee performance management and professional development for all direct reports.
Serve as 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 at industry conferences.
Ensure all research is conducted ethically and adheres to 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.