SR Assoc Director, Site Management Lead (Hybrid/On-site)

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Senior Associate Director (SAD) Site Management Lead will support the Executive Director Site Management & Monitoring to oversee US clinical programs effectively and efficiently across multiple therapeutic areas in full compliance with GCP/ICH, quality, safety of patients and business goals. The SR AD, Site Management Lead is responsible for forecasting and providing oversight of resources supporting US Clinical Trial Managers (CTMs)and managing the Site Enablement and IC teams. This role is responsible for resources and direct reports under the oversight of the SAD Site Management Lead are responsible for the Site Management and Regulatory Ethics Committee/Institutional Review Board (IRB) submissions, inclusive of trial participation and informed consent to ensure activities on clinical trials are completed in accordance to milestones, timelines and quality.

The SR AD, Site Management Lead is accountable for end-to-end site management including resource forecasting, on-boarding, and performance tracking for FSP/ISP staff across all US clinical programs across Therapeutic areas, i.e., Clinical Associates (CAs), Clinical Trial Operations Specialist (CTOS), Regulatory Start Up Specialist (RSUS), Informed Consent Specialist (ICS) Site Activation Manager (SAM), Establishes standards. This role collaborates with internal stakeholders to support the allocation of resources and coordination of all staffing decisions. The incumbent is responsible for providing direction and management for direct reports assigned Site Management activities supporting trials conducted within Therapeutic Area(s). The CD&O line manager is responsible for providing strong leadership that is aligned to the HPBU intent, Medicine and CD&O vision, strategies, goals, and operating model to ensure successful delivery (speed & value) of clinical trials in the team.

The line manager is responsible for the execution, delivery and oversight of high-quality clinical trials that meet pipeline commitments, specific scientific medical, and regulatory requirements in the team as well as responsible for team performance oversight and excellence. This role embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk talking and one common CD&O identity.

Duties & Responsibilities

• Builds, develops and maintains close working relationships with Clinical Development & Operations (CD&O) functional groups, e.g., Legal, Ethics & Compliance and third-party vendors including CROs, IRBs to assure a closely coordinated program of activities based on common objectives and focusing on value, quality and operational efficiencies.
• Provides leadership and strategic direction to the Site Enablement Team.
• Maintains oversight of the trials at all stages of conduct to ensure operational vendor oversight;
• Ensures delivery of site management activities and regulatory document collection (review, and approval of site essential documents, including placement in relevant systems (e.g., Clinergize)) is executed per regulations, process and in accordance with business needs.
• Provides comprehensive oversight of all regulatory submissions to IRB across all trials and therapeutic areas.
• Identifies and communicates operational issues and trends across the portfolio of trials based on input from 3rd party vendor(s), Regulatory Start Up Specialists (RSUS), trial team, and/or IRB vendor.
• Implements corrective actions/process improvements inclusive of audit findings and CAPAs to maintain and enhance overall trial execution and quality; represents all site management and regulatory document activities across trial portfolio. Oversee external Site Management FSP/ISP resources ~ 100-150.
• Leads continuous improvement strategies within the Site Management group and identifies ways to streamline work processes to support quality improvement initiatives.
• Leads and/or represents Site Management function as Subject Matter Expert (SME) on local/global working groups.
• Leads Site Management inspection readiness activities, participates in Sponsor Inspections and support research site health authority inspection(s).
• Ensures quality and compliance in support of regulatory applications;
• Supports leadership in qualifying vendors (e.g., IRB).
• Oversees and maintains accountability for Key Performance Indicators (KPIs) as provided by internal and external stakeholders vendor(s).
• Liaises and escalates as appropriate with BIPI Vendor Management to maintain quality and enhance performance of the operating model.
• Projects and forecasts current/future resourcing needs to ensure business continuity; ensures appropriate allocation and capacity planning to optimize utilization of resources.
• Identifies trends and implements effective change to maximize efficiencies and utilization of resource(s).
• Manages functional budgets, including resource projections, capacity assessments and vendor(s)(e.g. FSP, ISP)oversight and evaluation of services in the Site Management Function, to ensure adequate and appropriate resourcing for the on-time delivery of all trials in the BIPI portfolio.
• Guides efforts of third-party vendor(s) to ensure deliverables assigned to resources are completed to high quality within planned timelines.
• Monitors and approves service invoices, as appropriate.
• Maintains a focused continuous improvement culture by identifying and executing strategies and priorities to enable milestone delivery and to enhance overall operational effectiveness.
• Actively remains current with industry standards, trends, and competitive intelligence and best practices.
• Identifies, develops and implements process improvements (e.g., SOP/KM Assets/HTGs) to drive efficiencies, ensure consistency and alignment across CD&O.

Requirements

• Bachelor degree (preferred major/focus: Health Sciences, Health Care, Nursing or Others) with 7 years relevant experience.
• OR
• Masters or Advanced degree with five-plus (5+) years’ experience.
• Minimum three (3) year of direct/matrix line management experience.
• Demonstrated experience in the regulated pharmaceutical or healthcare industry with a focus on operational and technical experience managing regulatory document work packages across the life cycle of a clinical trial.
• Advanced understanding of all phases of drug development (I-IV) as well as knowledge to implement FDA/ICH/GCP/HIPAA regulations, guidance, and legal understanding.
• Understanding of Federal Regulations pertaining to IND and NDA regulations.
• Track record in setting priorities, organization and problem-solving skills which support and enable sound decision making.
• Excellent customer service skills and high attention to detail.
• Demonstrated analytical skills and critical thinking with the ability to proactively identify and resolve issues with a solutions-oriented approach in a variety of complex situations requiring new solutions.
• Experience initiating and leading department and cross-functional strategic initiatives.
• Proficient written and verbal communication skills and the ability to be clear and concise in a variety of communication settings.
• Proficient organizational and effective time management skills with the ability to work well under pressure.
• Exercise sound judgment in planning and accomplishing goals.
• Ability to use and learn system applications, e.g., MS Office, document management systems, etc.
Ability to travel overnight domestically and/or internationally, as needed.

Eligibility Requirements :

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Compensation