Director, Clinical Operations

McKesson requires new employees to be fully vaccinated for COVID-19 as defined by the CDC, subject to applicable, verified accommodation requests.

Key Responsibilities

1. Oversight of clinical trial programs within the USOR network

Integrates activity and direction across multiple workgroups, departments, or districts within the same functional area. In some cases, this may include responsibility or other nonrelated workgroups who fall 'under the umbrella' of the function (e.g., local facilities staff reporting to finance or legal, etc. May have budgetary responsibility. Accountable for customer satisfaction, programs, products, and employees for assigned area of responsibility.

Typically manages employees from multiple disciplines within a related function within a clearly defined geographic area or country. Within Sales function, manages current quarter pipeline proactively based on company needs and availability of resources.

Decisions will impact schedules and/or unit operations and may result in delays that could jeopardize overall business activities. Decisions or failure to achieve results will add to cost and may impact the medium-term goals of the organization

Works on complex to highly complex issues where analysis of situation requires a good understanding of organizational objectives. Integrates the activities of multiple workgroups and disciplines to obtain results. Frequently interacts with direct reports, customers, managers, and/or peer group managers. May interact with senior management. Interactions normally involve matters between functional areas or customers and the Company. Communicates organizational and functional strategy and translates it into functional goals

• Provide direction to Program Lead and/or Sr. Clinical Trial Manager to ensure protocol research opportunities are effectively managed from study start up through finish. Develop strategies to navigate through complex problems and provide resolution. Act as escalation point for business partnering issues and challenges to ensure customer satisfaction. Collaborates with cross functional leadership to determine trial priority and appropriate management of program portfolios.
• Provides oversight and direction for protocol alignment processes which includes review of Medicare coverage analysis, research budget grid and informed consent document. Collaborates with finance, legal, regulatory affairs, and site services to resolve alignment discrepancies.
• Proactively monitors program progress and performance, timelines and financial metrics on an ongoing basis and forecasts budgetary requirements based on scope of work. Review and approve protocol budgets for consistency and completeness. Actively analyze and approve expenses to ensure compliance with outlined parameters.
• Collaborates with physician leaders, investigators, and USOR leadership in setting the strategic direction for assigned US Oncology Research clinical programs. Directs process continuity and adherence to timelines for new study opportunities. Oversees pipeline forecasting and milestones for overall program with support for accrual action plans and potential site replacements. Collaborates with Site Services to address barriers with sites and sponsors.

2. Leadership of a team of research professionals to optimize execution of USOR objectives including education and training activities.

Manages activities of broad functional areas throughout the clinical operations area including first level managers and specialist individual contributors. Assists with the development of group, function, department, or district goals and performance standards/metrics. Responsible for creating and implementing staffing model. Provides oversight and guidance for interviewing, hiring, assessing, and managing performance, recommends salary changes and progressive discipline. Administers policy and practices related to employee relations in conjunction with HR. Analyzes workload, prioritizes tasks, provides direction for staffing across all programs to maximize productivity and meet business needs. Provides support and education to the clinical trials team to ensure knowledge and fluency with designated protocols including financial implications related to routine care vs. research related charges. Develops workflow guidance processes and documents for operations activities and provides routine staff training to ensure compliance with processes. Oversees staff training programs, provides coaching and career development, and designs and develops curriculum as needed. Collaborates with cross functional teams to determine training topics and pursues training opportunities from outside sources. Assist with development and administration of USOR polices and standard operating procedures, identifies gaps and ensures compliance. Identify and test opportunities to improve team performance and systematically incorporate value-added practices. Partners with cross-functional leadership to routinely review and update learning modules. Mentor staff in development of behavioral and functional skills related to job performance. Collaborates with Research Optimization and Site Services to develop educational opportunities for USOR sites and staff. Fosters a transparent environment that encourages strong partnerships between cross-functional teams, including finance, legal, regulatory, and quality assurance.

Responsible for the interviewing and hiring of Research Operations staff to keep equity among the staff and in keeping with staffing model.

3. Serve as a resource to the USOR Business Development, Site Services, QA, Regulatory, and any internal USOR team or to Sponsor and/or CRO related to study opportunities and all clinical trials

• Applies knowledge of current oncology landscape to identify gaps in USOR portfolio to guide business development activities. Maintains communication with Site Services leadership to assess site capabilities, clinical areas of interest and performance. Collaborates with Site Services and regional directors to ensure sites meet study expectations, including but not limited to accrual, data entry and quality, and overall adherence to GCP and USOR SOPs. Monitor, maintain and identify opportunities for quality improvement initiatives within clinical research programs. Identifies trends and opportunities for process improvement in the organization and works closely with cross functional leaders to develop best practices. Actively encourage the six-sigma program (Research Optimization) of continuous improvement by identifying cost reduction or quality improvement initiatives and sponsoring those initiatives as a process owner.

4. Cultivate USOR business relationships with external clients

Develop and maintain relationships with key external stakeholders by fostering collaboration and establishing clear expectations to drive business decisions. Responsible to serve as the expert in the organization related to USOR operational discussions with customers. Develop and execute strategy plans to ensure alignment with organizational goals, improvement initiatives and operational excellence that are critical to the success of client/USOR relationships.

5. Performs other duties consistent with the job classification, as required.

Minimum Job Qualifications (Knowledge, Skills, & Abilities):

• Knowledge and understanding of the Oncology clinical research setting (required)
• 12 years of experience conducting clinical trials/clinical research industry
• 5 years management experience
• CCRP, CCRA, CCRC certification is a plus

Education/Training:

• Advanced clinical/life science degree (PharmD, Advanced Practice RN, MD, PA, MSN, PhD, etc.); consideration will be given to candidates with Bachelor’s degree with 8 years of equivalent experience and research certification

Critical Skills:

• Experience in clinical drug development, investigational pharmaceutical research
• Managing development and/or operations teams
• Knowledge of pharma clinical research and development process essentialExperience with electronic health records, experience with CTMS preferred.
• Ability to adapt quickly to new situations, as well as new and changing processes, programs, and services
• Strong analytical and operational planning skills
• Establish and analyze business metrics to effectively set targets and standards of performance
• Strong problem solving, decision-making, conflict resolution, leadership and team building skills.
• Takes initiative, handles day to day work challenges confidently, multiple demands, shifting priorities; shows resilience in the face of constraints, demonstrates flexibility
• Excellent communication, interpersonal and organizational skills (verbal and written)
• Strong clinical study management skills to include understanding of GCPs, ICH and knowledge of regulatory requirements.
• Shows work commitment’ sets high standards of performance; pursues aggressive goals and works efficiently to achieve them

Additional Skills/ Knowledge:

• Understanding of how clinical research works in a community setting
• Advanced knowledge of healthcare and the specific systems area related to the management position.
• Knowledge of oncology and related disciplines and treatment patterns preferred.
• Proficiency with computer systems and Microsoft Office Suite (Outlook, Word, Power Point, and Excel)

Working Conditions:

Environment (Office, warehouse, etc.) – General Office may require travel by air or automobile approximately up to 25% of the time.

Physical Requirements (Lifting, standing, etc.) – Large percent of time performing computer-based work is required.

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAcquisition@mckesson.com . Resumes or CVs submitted to this email box will not be accepted.

Current employees must apply through the internal career site.

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