Senior Director, Clinical Product Operations and Delivery

TeraRecon; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

A leading innovator in healthcare technology is seeking a strategic leader for their Clinical Trials Products organization. This role focuses on AI-driven solutions to enhance clinical research workflows, improve data quality, and reduce costs. The ideal candidate will have extensive experience in clinical trial operations, particularly in oncology, and a strong background in project management. Join a dynamic team dedicated to transforming healthcare and making a significant impact on patient outcomes.

Qualifications

• 8-10 years’ experience in clinical trial operations management, oncology specific required.
• Experience in clinical trial supporting technologies and platforms, SaaS solutions preferred.

Responsibilities

• Lead and scale the Clinical Trials Product Delivery and Engagement team.
• Ensure engagement success by identifying quality risks and issues.
• Accountable for regulatory and audit-readiness.

Skills

Leadership

Project Management

Problem Solving

Communication

Teamwork

Education

Bachelor’s degree

Tools

MS Office

Job description

Job Requirements

Company Overview

ConcertAI is at the forefront of revolutionizing healthcare with our cutting-edge AI and data solutions. Our mission is to accelerate insights, advance research, and improve patient outcomes in oncology and across life sciences. As a leader in real-world evidence (RWE) and data-driven technology, ConcertAI partners with top pharmaceutical companies, healthcare providers, and research institutions to enhance patient outcomes and streamline clinical research. By leveraging evidence-generation and artificial intelligence, we deliver unparalleled insights into treatment effectiveness, patient care, and disease progression to advance precision medicine and medical innovation.

Within the ConcertAI ecosystem, TeraRecon is a leading innovator in advanced visualization, artificial intelligence (AI), and image analysis solutions for healthcare. With a focus on improving clinical workflows and enhancing diagnostic precision, TeraRecon offers scalable platforms like Intuition and Eureka AI to integrate imaging, data, and AI-driven insights seamlessly. Additionally, CancerLinQ, an oncology-focused platform developed by ASCO and now part of ConcertAI, supports cancer centers and practices in improving care quality and discovery.

Joining ConcertAI means becoming part of a visionary team dedicated to transforming the healthcare landscape. You'll have the opportunity to work on innovative projects that directly impact patient lives, collaborate with some of the brightest minds in the industry, and be at the cutting edge of technological advancements in healthcare. ConcertAI offers a dynamic and inclusive work environment, competitive benefits, and ample opportunities for personal and professional growth. If you're passionate about making a difference in healthcare and excited by the prospect of working with advanced AI and data solutions, ConcertAI is the perfect place for you to thrive and make a lasting impact.

Role Summary

Our AI powered products that are part of the Digital Trial Solutions business unit help life sciences companies optimize their protocols, improve site selection, find patients that meet specific trial criteria and significantly reduce the burden of trial data collection. We are bringing clinical trials from our pharma partners to our expanding community oncology practice focused site network which is increasing the geographic reach and patient diversity of trials.

In this role for our Clinical Trials Products organization, you will play a strategic leadership role in shaping and executing our vision for high growth, AI driven solutions, products, and platforms that significantly accelerate and streamline clinical research related workflows and efforts, improving timelines and data quality while reducing costs and resource needs, to enable sponsors and sites to execute more successful clinical trials with a fraction of the resources currently required.You will be working with teams leveraging the most cutting-edge technologies, including agentic and generative AI, to fundamentally change how clinical trials are designed and executed.

Responsibilities

• Lead, develop and scale the Clinical Trials Product Delivery and Engagement team in resources, skill sets and capabilities, enriching offerings and support capabilities over time.
• Act as primary product/project/program/portfolio contact with customer upon contract execution and own relationship with key customer contact(s); strategize ConcertAI business development as necessary.
• Ensure engagement success by identifying quality risks and issues, responding to issues raised by customers and internal team members and planning/implementing appropriate corrective and preventative action plans.
• Direct, oversee and develop appropriate engagement management programmatic infrastructure inclusive of project management and communication plans, and accountability for the development of and adherence to unit-specific SOPs, MOPs, WIs and GDs.
• Oversee the development of integrated product and study management plans with the core product and engagement teams.
• Accountable for regulatory and audit-readiness, working interdepartmentally to support the programmatic establishment of trial-specific systems of record, preparation for, conduct of and responses to internal and external trial audits.
• Develop appropriate trial data and informational repositories at study close-out and, in cooperation with QA, trial archival systems and appropriate processes with an eye to retrieval and audit readiness.
• Provide executive-level project strategy and delivery support for the Clinical Trials business unit across the internal departments such as Engineering and Product Development, to facilitate communication, adherence to deadlines and internal management strategy, transparency, messaging, escalations, and expectations as needed.
• Ensure budgets, trial enrollment and gaiting are accurate; ensure communication of program status, cost and issues to inform timely decision-making by senior management.
• Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
• Independently manage systemic issues at an engagement or portfolio level and identify solutions with product and project teams, recommend actions to improve efficiencies and oversee the implementation of best practices, address escalation items with the customer.
• Cultivate relationships pre-contract and support ongoing client management activities with prospective and existing clients upon hand off from Business Development, Provider Partnerships and/or Customer Success as needed.
• Contribute to the development of the delivery strategy for Request for Proposals (RFPs) by supporting the SVP of CDT with input on operational and project delivery resourcing and timelines to help scope and budget for SOWs and outgoing contracts.
• Participate in bid defense preparations. Lead bid defense presentations in partnership with business development for large, complex, multi-service, multi-region engagements, studies and/or programs. Drive development of engagement strategy and operationalize the agreed upon approach.
• Participate in, champion, and adopt function and/or corporate initiatives, changes and/or special project assignments, act as a client liaison, departmental cross-functional liaison and/or change agent.
• Provide input to line managers of their project team members' performance relative to project tasks. Recommend team members' further professional development. Support staff development.

Requirements

• Bachelor’s degree coupled with at least 8-10 years’ experience in clinical trial operations management, with oncology specific experience required with at minimum 7 years’ experience in Clinical Project Delivery
• 5-8 years’ experience in clinical trial supporting technologies and platforms, with specific experience in SaaS solutions, preferred
• Demonstrated excellence in leadership and operations and project management, including innovative operations approaches to achieving study goals
• Familiarity with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
• Experience must include operational support and execution of Phase 2 and 3 studies and global/international programs
• Experience in more than one therapeutic area is strongly preferred
• CRO and/or pharmaceutical industry experience required
• Experience in analyzing and interpreting processes, revenue, and annual budgets
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
• Excellent written and verbal communication, presentation, and people management skills required
• Pragmatic and willing to drive and support change
• Comfortable with ambiguity
• Supportive of a culture of continual improvement and innovation; promote knowledge sharing
• Able to work successfully in a diverse team environment
• High proficiency with MS Office.
• Required fluency in business English (oral and written).

Learn More About ConcertAI

Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI atwww.concertai.com, or follow us onLinkedIn.Serving 1,300 clinical sites globally, TeraRecon - a ConcertAI company - is a Best in KLAS solution provider for AI-empowered radiology, oncology, cardiology, neurology, and vascular surgery. In the future, the combination with ConcertAI could bring a single, advanced AI-augmented diagnosis and interpretation capability from clinical trials to patient care. Learn more about TeraRecon atwww.terarecon.com , or follow us on LinkedIn.

EEO

ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.