Department: Development Operations & Biometrics (DO&BM)
Reports To: Head of Development Operations & Biometrics
Location: Princeton, NJ, United States
Travel: Approximately 10-20%
Job OverviewKardigan is seeking a Senior Director, DO&BM Strategy & Operational Excellence to serve as a trusted advisor to the Head of DO&BM and the strategic integrator for the function, aligning priorities, governance, operating practices, and cross-functional execution to enable high-quality clinical development across the product lifecycle.
This is a dual-mandate role. On one side, the Senior Director sets and drives DO&BM's strategic agenda-organizational design, annual planning, governance, performance management, and leadership-team effectiveness-ensuring DO&BM operates as a coordinated, high-performing organization aligned to corporate objectives. On the other, the Senior Director leads the advancement of Risk-Based Quality Management (RBQM), Quality by Design (QbD), process simplification, and data- and technology-enabled ways of working across the clinical development organization.
Reporting directly to the Head of Development Operations & Biometrics, the Senior Director will serve as a trusted strategic partner to senior leaders within DO&BM and partner across Clinical Development, Quality, Regulatory, Pharmacovigilance, Finance, and IT to translate 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 successful candidate will bring deep knowledge of clinical drug development, exceptional organizational and communication skills, and the ability to influence outcomes without direct authority in a fast-paced biotech environment. This role starts with a small team and is mandated to build capability over time.
Key ResponsibilitiesDO&BM Strategy & Organizational Leadership- Lead the 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 and manage the Operational Excellence team and partner with cross-functional Strategy & Operations counterparts to ensure enterprise alignment.
- Identify emerging risks, opportunities, and organizational challenges, providing recommendations and actionable solutions to the DO&BM leadership team.
- Lead the annual planning process for the function, including budget development, resource allocation, and goal setting.
- Develop and maintain global standards and best practices for DO&BM in collaboration with key cross-functional partners.
- Own the metrics and KPI framework that monitors 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.
Leadership Team Effectiveness & Governance- Design and run the DO&BM governance model-decision rights, forums, cadence, and escalation paths-so that the leadership team operates with clarity and speed.
- Set the agenda for and lead key leadership forums, including senior leadership team meetings, town halls, and off-sites, driving content, decision capture, and accountability for follow-through.
- Shape and author functional and executive communications and presentations that carry the leadership team's message consistently across the organization.
- Represent DO&BM leadership at internal and external forums as applicable.
- Build strong 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 the capability as the portfolio and organization grow.
Operational Excellence- Define and lead enterprise-wide transformation strategies (including change management approaches) that simplify and standardize end-to-end clinical development processes.
- Identify opportunities to eliminate unnecessary complexity, improve decision-making, reduce cycle times, and increase consistency across clinical development programs.
- Lead strategic initiatives that modernize clinical development through process redesign, technology, analytics, automation, and innovative ways of working.
- Champion change management initiatives that support organizational transformation and ensure new ways of working are adopted and sustained.
- Develop communities of practice and learning strategies that strengthen organizational expertise in RBQM, quality, process excellence, and data-driven clinical development.
Risk Based Quality Management- In collaboration and alignment with Clinical Operations, Biometrics, and Quality, define and advance enterprise strategies for Risk-Based Quality Management (RBQM), Quality by Design (QbD), and proactive clinical trial risk management.
- Partner with DOBM functions to integrate quality and risk management principles into functional processes, governance, study planning, monitoring, and oversight with clear ownership for execution.
- Establish fit-for-purpose frameworks for risk identification, assessment, escalation, mitigation, and issue management to be executed within defined functions and continuously monitored for improvement.
- As the leader of Operational Excellence, partner with Quality and DOBM functional leaders to strengthen inspection readiness, GCP compliance, and a sustained culture of quality across the organization.
- 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.
Data Driven Insights and Quality Indicators- Partner with DO&BM functional leaders to identify opportunities to use data, analytics, automation, and emerging technologies to strengthen operational and quality decision-making, align priorities, and support implementation by functional owners.
- Translate business needs into practical technology solutions and user-centered products.
- In partnership with the Head of AI Enablement, drive the implementation and adoption of AI-enabled process improvements across DO&BM.
- In partnership with the Head of Data Analytics, identify opportunities to apply advanced analytics, predictive modeling, machine learning, and automated signal detection to trial oversight.
Leadership Expectations- Demonstrate enterprise-level strategic thinking while maintaining a strong working understanding of clinical development execution.
- 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.
- Balance quality, compliance, patient protection, operational efficiency, and speed.
- Create a culture of continuous improvement, accountability, innovation, and quality by design.
- Exercise sound judgment, discretion, and confidentiality in all aspects of the role.
Qualifications and Preferred Skills- Bachelor's degree in life sciences or a related field required; Master of Science, Ph.D., or MBA preferred. PMP certification preferred.
- 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 is 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.
- Experience with process excellence methodologies (Lean, Six Sigma) is highly desirable.
- 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.
Success MeasuresSuccess in this role will be demonstrated through:
- A DO&BM leadership team that operates as a coordinated, high-performing organization with clear governance, priorities, and accountability.
- Reduced complexity and cycle times across clinical development processes.
- Increased adoption and consistent application of RBQM and Quality by Design principles.
- Improved clinical trial quality and proactive risk identification.
- Increased use of data and analytics in operational and quality decision-making.
- Improved inspection readiness and compliance.
- Successful adoption and sustainability of new processes, technologies, and operating models.
- Increased stakeholder engagement and measurable growth in organizational capability.
- Demonstrable business impact from transformation and continuous improvement initiatives.
