Clinical Systems Lead Director - Wilmington
13 hours ago
Job description
Job Summary (General Purpose of the Job)The Director, Clinical Systems Lead is the accountable owner for the strategy, delivery, adoption, and value realization of enterprise clinical platforms that enable clinical trial execution, oversight, and regulatory inspection readiness.
Examples of platforms include the in-house clinical trial data visualization tool, protocol digitization, and Veeva clinical modules.Operating in a regulated (GxP) environment, this leader sets the product roadmap, prioritizes funding across competing demands, drives measurable business outcomes, and ensures solutions meet clinical, operational, analytical, and regulatory needs.
The role partners deeply with Clinical Development, Clinical Operations, Data Management, and Quality Assurance.Essential Functions of the Job (Key Duties and Responsibilities)
- In partnership with clinical leadership, owns platform strategy and multi-year roadmap, including investment cases and value commitments.
- Defines and operates the product delivery and run model, including release management, validation approach, and support SLAs.
- Accountable for adoption, behavior change, and value realization tied to business outcomes.
- Establish and operate a scalable product‑based delivery and support model, balancing innovation, compliance, and operational stability.
- Leads vendor strategy, selection, and performance management to ensure delivery meets quality, cost, and compliance standards.
- Act as the key liaison across all functional areas including business units (specifically, Data Management, Clinical Development, Development Operations, and Quality Assurance), IT, and outside vendors.
- Maintain alignment with compliance, validation, privacy, and data governance standards in a GxP environment.
- Participate in strategic and budgetary planning processes.
- Lead and develop a high-performing team, including internal staff and vendor partners. Manage assigned resources appropriately so that project timelines and defined objectives are met.
Minimum (Required)
- Bachelor's degree in Life Sciences, Information Technology, Computer Science, Engineering, or a related field. Advanced degree preferred.
- 10+ years of experience in clinical IT or related fields in the biotech/pharmaceutical industry.
- 5+ years of experience in a people or program leadership role.
- Substantial end-to-end clinical development experience (specifically, clinical trial data, clinical trial protocols, and Veeva clinical modules [EDC, IRT, eCOA]).
- Strong working knowledge of Power BI and data lake or warehouse architectures.
- Demonstrated ability to partner effectively with Clinical Development, Development Operations, Data Management, and Quality Assurance.
- Demonstrated experience supporting regulatory inspections (FDA, EMA) and operating in GxP environments.
- Effective written and verbal communication skills to a variety of business and technical audiences.
- Ability to establish and maintain strong relationships.
- Experience with protocol digitization solutions.
- Experience operating a product-based delivery model for enterprise platforms.
- Proven track record delivering quantified business value.
Salary:
Up to $250,000
Exact compensation may vary based on several factors, including skills, experience, and education.
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