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

Kardigan•Princeton, NJ

About The Position

Kardigan is seeking a Senior Director, Development Operations & Biometrics (DO&BM) Strategy & Operational Excellence to serve as a trusted advisor to the Head of DO&BM and as a 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. The position 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. The Senior Director translates strategy into practical operating models, standards, processes, governance, and solutions that strengthen organizational effectiveness and improve quality, compliance, efficiency, and speed. Reporting to the Head of Development Operations & Biometrics, the role partners with senior leaders across DO&BM and with Clinical Development, Quality, Regulatory, Pharmacovigilance, Finance, IT, and other functions. It begins with a small team, with a mandate to build capability over time. The role is based in Princeton, New Jersey, and involves 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 (stated as 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.
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 coordinate with cross-functional Strategy & Operations counterparts.
Identify emerging risks, opportunities, and organizational challenges, and provide recommendations and actionable solutions to DO&BM leadership.
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 talent, capability, and career-development initiatives.
Design and operate 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 follow-through.
Shape and author functional and executive communications and presentations.
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 multiple functions, vendors, and technology partners.
Build, lead, and mentor a small high-performing team, scaling capability as the portfolio and organization grow.
Define and lead transformation strategies, including change management, to simplify and standardize end-to-end clinical development processes.
Identify opportunities to reduce unnecessary 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 transformed ways of working are adopted and sustained.
Develop communities of practice and learning strategies in RBQM, quality, process excellence, and data-driven clinical development.
Work with Clinical Operations, Biometrics, Quality, and DO&BM functions to advance RBQM, QbD, and proactive trial risk management and integrate these principles into processes, governance, study planning, monitoring, and oversight.
Establish fit-for-purpose frameworks for risk identification, assessment, escalation, mitigation, and issue management, with clear ownership and ongoing monitoring.
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 to inform strategic decisions and maintain compliance.
Partner with DO&BM functional leaders to identify and implement opportunities to use data, analytics, automation, and emerging technologies for operational and quality decision-making.
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, efficiency, and speed.
Promote continuous improvement, accountability, innovation, and quality by design, while exercising sound judgment, discretion, and confidentiality.