Associate Director, Site Enablement

Role Description

The Associate Director, Site Enablement - Oncology Delivery Unit (DU) will be accountable for the operational management and successful country execution of all phases of clinical trials within the assigned therapeutic area(s), including:

• Resource allocation
• Adherence to timelines and budget
• Compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC), and local regulatory requirements

This individual will be responsible for line management of:

• Local Trial Managers (LTMs)
• Site Managers (SMs)
• Clinical Trial Assistants (CTAs)
• Other DU staff (including Manager, Clinical Operations)

Key responsibilities include:

• Providing line management to direct reports, including setting goals and objectives, performance evaluation, and talent development
• Evaluating and forecasting resource needs for assigned portfolio
• Deployment of the One Delivery Model through collaboration and oversight of vendors
• Accountability for the acquisition of new talents and development of human resources
• Guiding direct reports in issue resolution and communication with stakeholders
• Leading organizational changes and effectively communicating on priority shifts
• Reviewing and approving expenses in compliance with company policies
• Demonstrating leadership behaviors in alignment with Johnson & Johnson Leadership Imperatives
• Fostering an environment that encourages sharing of ideas, information, and best practices
• Providing coaching and mentorship as needed
• Defining, executing, or supporting long-term strategy in alignment with DU, GD, and JJIM R&D strategies
• Oversight of execution and monitoring of clinical trials through all phases
• Accountability for ensuring relevant operational objectives are met
• Accountability for appropriate and timely issue escalation and reporting
• Contributing to Corrective and Preventative Action (CAPA) and issue resolutions
• Shaping and maintaining strong relationships within local DU department and Local Operating Company
• Developing country capabilities for effective study placement
• Accountability for robust feasibility process and oversight of site selection
• Reviewing operational and quality metrics regularly and driving follow-up actions
• Driving innovative solutions and process improvements
• Modeling Credo-based culture within the local DU team

Qualifications

• A minimum of a bachelor’s degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• A minimum of 8 years of clinical research experience within the pharmaceutical industry, Contract Research Organization (CRO), and/or investigational site is required
• A minimum of 2 years of line management experience is required
• Experience managing a medium (5-9) to large (10+) size team of direct reports is preferred
• Experience in the Oncology (Solid Tumor and/or Hematology) Therapeutic Area is required
• Experience managing and executing clinical trials is preferred
• Knowledge of the drug development process, clinical research operations, and regulatory requirements is required
• Financial management skills (e.g., budgeting, forecasting, risk analysis) are required
• Must have excellent communication, interpersonal, and leadership skills
• Must have strong decision-making, issue resolution, and negotiating skills
• Must have flexibility to work in a fast-changing environment
• The ability to evaluate data generated from various reports and sources is required
• The ability to effectively communicate with various internal and external stakeholders is required
• The ability to collaborate with all levels of management and handle multiple priorities is required
• This position will require up to 10% travel

Benefits

• Vacation – 120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees in Colorado – 48 hours; for employees in Washington – 56 hours
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year