Senior Program & IT Leadership for Regulated Life Sciences

Program & Project Leadership Across Clinical, Safety, Quality, and Enterprise Platforms — Flexible, Experienced, and Independent

I partner with boutique, emerging, and mid-sized life sciences organizations, as well as highly regulated enterprises, to lead complex initiatives across clinical operations, safety, quality, R&D, and enterprise IT.

With experience spanning consulting engagements and in-house leadership roles, I step in quickly to establish structure, drive results, and deliver compliant, scalable outcomes across validated systems, SaaS platforms, and enterprise programs—without the overhead, staffing churn, or rigidity of large consulting firms. I also work seamlessly with internal teams and existing vendor ecosystems to ensure efficiency and alignment with organizational processes.

Core Service Areas

Program & Portfolio Leadership

Senior delivery leadership for multi-workstream initiatives requiring coordination across business, technical, and regulated functions. I establish structure, drive outcomes, and integrate with internal teams or vendor ecosystems as needed.

  • Key capabilities:

    • Program governance, execution, and executive reporting

    • Cross-functional risk, dependency, and issue management

    • Inspection and audit readiness support

    • Stabilization of complex or at-risk programs

Clinical, Safety & Development Platforms

Leadership for regulated platforms supporting clinical development, post-market oversight, and enterprise clinical operations

  • Key capabilities:

    • CTMS implementations, expansions, and replacements

    • eTMF implementations and large-scale migrations

    • eFeasibility platforms for investigator identification and screening

    • Argus Safety database consolidation and migrations

Quality, Compliance & Validation

Ensuring systems are fit-for-purpose, compliant, and inspection-ready.

  • Key capabilities:

    • Oversight of Computer System Validation (CSV) in partnership with QA

    • SOPs, work instructions, and operational readiness artifacts

    • QMS-adjacent system initiatives

    • Support for regulatory inspections and mock audits

Enterprise & R&D IT Enablement

Delivery leadership for foundational platforms that support scale, security, and data integrity across R&D and enterprise systems.

  • Key capabilities:

    • SaaS and cloud migrations

    • Collaboration platforms (e.g., SharePoint)

    • Financial, resource, and portfolio management systems

    • Data governance and master data initiatives

Vendor & Partner Oversight

Hands-on leadership for vendor-led programs, including engagements without a defined vendor PM. Ensures seamless coordination between internal teams and external partners.

  • Key capabilities:

    • Direct coordination with Clinical, Safety, QA, and IT teams

    • Oversight of validation, testing, and delivery resources

    • Clear accountability for outcomes—not just vendor activity

    • Integration with internal teams and existing vendor ecosystems for efficiency and alignment

Engagement Approach

I typically engage as:

  • Fractional Program or Portfolio Leader

  • Program / Project Manager

  • Interim Delivery Lead

  • Initiative Lead for regulated platforms and transformations

Engagements are tailored to organizational maturity, urgency, and regulatory complexity. I work flexibly with both small and mid-size organizations as well as larger, structured enterprises, complementing internal teams and existing vendor frameworks.

Services

Engagements focus on senior program and delivery leadership across regulated life sciences platforms—including clinical, safety, quality, and enterprise systems. Scope and structure are customized based on organizational maturity, regulatory context, and program risk.

Support is provided on a fractional, project-based, or advisory basis, enabling organizations to access experienced leadership without the overhead or rigidity of large consulting firms.

Engagement Structure & Pricing

Engagements are tailored to each organization's needs, maturity, and regulatory context. Support may be provided on:

• Hourly consulting for targeted leadership, advisory, or short-term support
• Monthly retainers for a fractional program or IT leadership
• Fixed-scope engagements for defined initiatives such as system implementations, migrations, or remediation efforts

Rates and structure are discussed following an initial alignment conversation to ensure the engagement is appropriately scoped, positioned for success, and aligned with internal teams and vendor ecosystems.

Experience

For representative examples of prior work, please see Selected Life Sciences Programs & Projects.