Associate Director, Site Enablement – Oncology Delivery Unit

Role Overview

• Accountable for the operational management and successful country execution of all phases of clinical trials within the assigned therapeutic area(s), or specific role(s)
• Oversee staff performance, development, training, project assignments, workload distribution and support issue resolution with direct reports.
• Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/Global Development (GD) overall.
• Provide line management to direct reports, including setting goals and objectives, performance evaluation and talent development.
• Evaluate and forecast resource needs for assigned portfolio and/or other specific areas of responsibility, as required and agreed with local DU management accordingly.
• Accountable for the acquisition of new talents and development of human resources.
• Lead organizational changes and effectively communicate on priority shifts as required.
• Ensure alignment of local goals with organizational objectives.
• Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s).
• Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
• Shape and maintain strong relationships within local DU department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.

Requirements

• 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, including ICH-GCP, Health Care Compliance (HCC) and applicable regulations, is required.
• Financial management skills (e.g., budgeting, forecasting, risk analysis, etc.) required.
• Must have excellent communication, interpersonal and leadership skills, with the proven ability to foster team productivity and cohesiveness.
• Must have strong decision-making, issue resolution and negotiating skills.
• Must have flexibility to work in a fast-changing environment and operate under limited supervision.
• The ability to evaluate data generated from various reports and sources is required.
• The ability to effectively communicate with various internal and external stakeholders (e.g., investigational sites, ethics committees, health authorities, etc.) is required.
• The ability to collaborate with all levels of management and handle multiple priorities within a matrix environment is required.
• This position will require up to 10% travel.

Tech Stack

• Google Cloud Platform

Benefits

• medical, dental, vision, life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• annual performance bonus
• Vacation
• 120 hours per calendar year
• Sick time
• 40 hours per calendar year
• 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
• Condolence Leave
• 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave
• 10 days
• Volunteer Leave
• 4 days
• Military Spouse Time-Off
• 80 hours