Senior Director, Development Operations & Biometrics, Strategy & Operational Excellence.

Kardigan•Princeton, NJ

About The Position

Kardigan is seeking a Senior Director, DO&BM Strategy & Operational Excellence to serve as a trusted advisor to the Head of Development Operations & Biometrics and as the strategic integrator for the function. The role aligns priorities, governance, operating practices, and cross-functional execution to support high-quality clinical development across the product lifecycle. It has a dual mandate: setting and driving DO&BM’s strategic agenda—including organizational design, annual planning, governance, performance management, and leadership-team effectiveness—and advancing Risk-Based Quality Management (RBQM), Quality by Design (QbD), process simplification, and data- and technology-enabled ways of working across clinical development. Reporting directly to the Head of Development Operations & Biometrics, the Senior Director partners with senior DO&BM leaders and teams across Clinical Development, Quality, Regulatory, Pharmacovigilance, Finance, and IT. The role translates strategy into practical operating models, standards, processes, governance, and solutions that strengthen organizational effectiveness and improve quality, compliance, efficiency, and speed across the clinical development portfolio. The position starts with a small team and is tasked with building capability over time. The role is based in Princeton, New Jersey, with approximately 10–20% travel.

Requirements

Bachelor’s degree in life sciences or a related field.
12+ years of experience in the pharmaceutical or biotech industry, including 5+ years in a leadership, strategy, or transformation capacity, with significant exposure to Clinical Operations and/or Biometrics preferred.
Demonstrated experience designing and implementing RBQM and Quality by Design approaches across a clinical development portfolio.
Proven track record in enterprise strategic planning, operational leadership, and cross-functional collaboration at scale.
Proven ability to influence senior leaders, build consensus, and drive organizational alignment without direct reporting authority.
Strong understanding of GCP, compliance frameworks, inspection readiness, and clinical operations.
Experience applying data, analytics, and emerging technologies, including AI, to clinical development oversight and decision-making.
Experience building and developing teams in a growing organization.
Exceptional communication, leadership, and analytical skills.

Nice To Haves

Master of Science, Ph.D., or MBA.
PMP certification.
Experience with process excellence methodologies such as Lean or Six Sigma.

Responsibilities

Lead strategic planning and execution of DO&BM initiatives aligned with corporate objectives.
Oversee and optimize organizational design and delivery through process improvement, change management, and performance tracking; lead the Operational Excellence team and partner with cross-functional Strategy & Operations counterparts to ensure enterprise alignment.
Identify emerging risks, opportunities, and organizational challenges, and provide recommendations and actionable solutions to the DO&BM leadership team.
Lead annual functional planning, including budget development, resource allocation, and goal setting.
Develop and maintain global DO&BM standards and best practices with cross-functional partners.
Own the metrics and KPI framework for organizational health and performance, including functional scorecards and quarterly business review materials.
Standardize onboarding and recruitment practices and lead functional initiatives focused on talent, capability, and career development.
Design and run the DO&BM governance model, including decision rights, forums, cadence, and escalation paths.
Set agendas for and lead leadership forums, including senior leadership team meetings, town halls, and off-sites; drive content, decision capture, and accountability for follow-through.
Shape and author functional and executive communications and presentations, and represent DO&BM leadership at internal and external forums as applicable.
Build partnerships across Clinical Development, Quality, Regulatory, Technology, G&A, and external partners; lead cross-functional teams and strategic programs involving functions, vendors, and technology partners.
Build, lead, and mentor a small high-performing team, scaling the capability as the portfolio and organization grow.
Define and lead enterprise-wide transformation strategies, including change management, to simplify and standardize end-to-end clinical development processes.
Identify opportunities to reduce complexity and cycle times, improve decision-making, and increase consistency across clinical development programs.
Lead initiatives to modernize clinical development through process redesign, technology, analytics, automation, and new ways of working.
Champion change management and ensure new ways of working are adopted and sustained.
Develop communities of practice and learning strategies that strengthen expertise in RBQM, quality, process excellence, and data-driven clinical development.
In collaboration with Clinical Operations, Biometrics, and Quality, define and advance enterprise strategies for RBQM, QbD, and proactive clinical trial risk management.
Partner with DO&BM functions to integrate quality and risk management into functional processes, governance, study planning, monitoring, and oversight, with clear execution ownership.
Establish fit-for-purpose frameworks for risk identification, assessment, escalation, mitigation, and issue management, with continuous monitoring for improvement.
Partner with Quality and DO&BM functional leaders to strengthen inspection readiness, GCP compliance, and a sustained culture of quality.
Use quality metrics, signals, and trends to identify emerging risks and enable proactive intervention; monitor industry trends and evolving regulatory guidance.
Partner with DO&BM functional leaders to identify opportunities to use data, analytics, automation, and emerging technologies to strengthen operational and quality decision-making and support implementation by functional owners.
Translate business needs into practical technology solutions and user-centered products.
Partner with the Head of AI Enablement to drive implementation and adoption of AI-enabled process improvements across DO&BM.
Partner with the Head of Data Analytics to identify applications for advanced analytics, predictive modeling, machine learning, and automated signal detection in trial oversight.
Influence senior stakeholders and drive alignment across complex organizational environments without relying on direct reporting authority.
Translate strategy into actionable operating models, processes, technology solutions, and measurable outcomes while balancing quality, compliance, patient protection, operational efficiency, and speed.
Foster continuous improvement, accountability, innovation, and quality by design, while exercising sound judgment, discretion, and confidentiality.