Site Director - Clinical Research

Headlands Research•Escondido, CA

1d•Onsite

About The Position

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. We’re seeking a Site Director to help us build our newest clinical research site located in Escondido, California. Reporting to the Senior Director of Regional Operations (RDO), the Site Director (SD) oversees daily operations at the site to ensure participant safety, sponsor satisfaction, and high-quality data. This role drives financial targets, enrollment goals, and Key Performance Indicators (KPIs), while ensuring strict adherence to Good Clinical Practice (GCP), International Council of Harmonization (ICH), applicable regulatory requirements and Company and site level policies and procedures. This role requires strong leadership and communication skills to guide and mentor staff, provide strategic direction, manage resources, and foster a collaborative environment to achieve research objectives.

Requirements

Bachelor's degree in a scientific, health-related, or business administration field or equivalent experience
1–3 years of direct People Management experience
3+ years as a Primary Clinical Research Coordinator
Demonstrate ability to motivate teams and lead planning/organization efforts
Strong critical thinking and proactive problem-solving abilities
Proficiency in Clinical Trial Management Systems and standard office software
Excellent interpersonal, written, and oral communication skills
Growth mindset and a commitment to continuous improvement
Strong conflict resolution and mediation skills; ability to manage and resolve disputes effectively
Strong ethical standards and professionalism

Nice To Haves

Advanced degree desirable

Responsibilities

Manage site facilities, workflows, and Clinical Trial Management Systems (CTMS) to ensure premium experience for study participants, staff, and sponsors
Monitor clinical study progress, review monitor reports, and create risk management/mitigation strategies during the full lifecycle of a study
Ensure that all studies are conducted in compliance with all applicable regulations, GCP, ICH, policies, and procedures. This work is supported by the RDO, Therapeutic Area Leadership (TA Leadership) and Quality team, which provides SOPs, training, best practices, quality reviews, issue resolution and expertise to ensure high-quality trial execution and that the site remains audit-ready for customer or regulatory inspections
Responsible for the lifecycle of all site regulatory documentation, from initial start-up through ongoing maintenance
Provide operational support for protocol-related questions and ensure all staff are trained on study-specific requirements, in coordination with the principal investigator
Oversee external site partners/vendors, including onboarding, training, and performance monitoring
Ensure proper storage and handling of study specimens and investigational products
Partner with Headlands’ Shared Services teams, including TA Leadership, Quality, Central Regulatory, Finance, Human Resources, Budgets and Contracts, Participant Recruitment, and Business Development, to drive site performance and operational execution
Partner with the RDO to align and execute on strategies to support organic growth at the site
Proactively communicate real estate, capacity, equipment, vendor, staffing, or training needs to the RDO/AD to ensure the site has the resources necessary to conduct ongoing and upcoming clinical trials
Manage the full employee lifecycle for all site personnel, including interviewing, hiring, onboarding, performance reviews, and disciplinary actions in partnership with the Human Resources Business Partner (HRBP)
Provide coaching, mentoring, and development plans for all direct reports and ensure that all site staff have coaching, mentoring and development plans to maintain high morale, retention, and an engaged workforce
Collaborate with the Medical Director office, RDO/AD, and HRBP, as applicable on investigator hiring, onboarding, training, development, performance management, and investigator development plans
Proactively assess staffing needs and manage coverage to ensure study participant safety and data integrity
Foster a collaborative and productive work environment that encourages continuous improvement
Lead regular team meetings to discuss status of current projects, plan for future projects, provide updates on new company initiatives, seek feedback regarding team barriers
Manage local team to meet/exceed quality and performance metrics, report key performance indicators to leadership team
Serve as a Culture Champion to support our mission and values
Own site-level financial performance by taking action to achieve revenue, expense, profitability, budget, and forecast targets
Partner with Finance and the RDO/AD to create, manage, and update accurate site budgets and monthly forecasts
Responsible for driving recruitment strategies to meet or exceed monthly participant screening, randomization, and retention targets
Develop and execute study-specific recruitment plans prior to study start, including hold lists, screening and enrollment monitoring, and plan adjustments as needed to meet enrollment goals, with the support of the Participant Recruitment team
Develop and support strategies to develop the site’s participant database through local community engagement strategies, physician-practice outreach, participation in community events, and pre-screening events
Serve as the primary point of contact between the site team and sponsors and Contract Research Organizations (CROs)
Participate in study feasibility processes, providing accurate site-specific data to secure future trials
Maintain current site information, including investigator Curriculum Vitae (CVs), site capabilities, equipment, vendor relationships, and operational constraints, to support accurate feasibility assessments and sponsor/CRO discussions
Communicate changes in investigator staffing, site capabilities, operational capacity, or strategic priorities that may impact current or future study opportunities
Drive the growth and development of the site by identifying areas for improvement and innovation while staying informed of industry advancements
Duties as assigned