Senior Manager, Biometrics Program Management

Senior Manager, Biometrics Program Management

Contact: Sabrina Garcia - [email protected]

No 3rd party candidates

The Senior Manager, Biometrics Program Management is responsible for integrated planning and delivery of critical data readouts across Biometrics, and for driving the centralized initiatives that cut across Biostatistics, Data Analytics and Data Management. This person owns the integrated readout plan, surfaces risks and issues early, and escalates with a clear recommendation when the critical path is threatened. The role also leads cross-cutting Biometrics initiatives, such as data governance, vendor transitions and tooling investments, and builds the operating rhythm that keeps Biometrics visible and predictable to the rest of Development.

Functional heads remain accountable for the quality and timeliness of their own deliverables. This role is accountable for the integrated plan, the cross-functional view of readiness, and the discipline of the process that connects them.

How You Will Spend Your Day

• Readout execution
• Own the integrated readout plan for assigned programs, covering data cut, data cleaning, database lock, analysis dataset, TFL production and topline delivery milestones across Biostatistics, Data Analytics and Data Management.
• Define readiness gates with functional leads and run gate reviews, with clear criteria for proceeding, delaying or descoping.
• Maintain a single risk and issue log tied to the critical path, with owners, mitigations, due dates and a full life cycle from identification to closure.
• Facilitate input and alignment with Clinical Development, Clinical Operations, Medical and Safety Monitoring, Regulatory, CRO and other vendor partners to confirm data and decision needs for each readout.
• Escalate threats to timeline or data quality early, with options and a recommendation, to the Head of Biometrics and Development leadership.
• Lead post-readout retrospectives and feed lessons learned into templates and plans for the next readout.
• Centralized initiatives
• Provide program management for cross-cutting Biometrics initiatives, including data governance, process harmonization, vendor consolidation and transition, and systems and tooling implementation.
• Translate initiative goals into scoped plans with milestones, resourcing needs, budget tracking and measurable outcomes.
• Gather requirements across functions and partner with Data Analytics and Data Management to define dashboards and visualizations that give leadership a clear view of data status and risk.
• Contribute to and, where assigned, lead departmental process improvement and innovation efforts.
• Operating rhythm and communication
• Establish and run the standing cadence of Biometrics status reporting, decision tracking and cross-functional forums.
• Prepare concise leadership updates that distinguish what is on track, what is at risk and what decisions are needed.
• Maintain consistent planning templates, tools and definitions so that readouts and initiatives are reported the same way across programs.
• Vendor and partner management
• Partner with functional leads to manage CRO and service provider performance against agreed deliverables and timelines.
• Support governance meetings, scorecards and issue escalation with vendor partners.

What You Bring

Required

• Bachelor's degree in a scientific, quantitative or related field. Advanced degree or PMP (or equivalent) preferred.
• 7 or more years of experience in the pharmaceutical or biotechnology industry, including at least 4 years in program or project management supporting clinical data, biostatistics, programming or data management.
• Demonstrated experience planning and delivering clinical data readouts, such as interim analyses, topline results or submission-enabling datasets.
• Working knowledge of the clinical data life cycle, including EDC, data cleaning, database lock, CDISC standards and analysis deliverables, sufficient to challenge plans and spot risk.
• Track record of leading cross-functional work without direct authority, and of escalating clearly and early.
• Strong command of planning, risk and issue management tools and methods.
• Excellent written and verbal communication, with the ability to give concise, direct updates to senior leaders.

Preferred

• Experience in a growing or clinical-stage organization where processes are still being built.
• Experience with CRO and vendor oversight, including governance and transitions.
• Familiarity with data governance, risk-based quality management, or data visualization and review platforms.
• Experience supporting regulatory submissions or health authority interactions.
• Success Measures
• Readouts delivered on the committed timeline with data quality that meets the agreed standard.
• Risks and issues identified and escalated with enough lead time for leadership to act.
• Centralized initiatives delivered against scope, schedule and budget with measurable adoption.
• Leaders across Development have a consistent, trusted view of Biometrics status.

Working Relationships

• Reports to the Head of Biometrics. Works daily with the heads and teams of Biostatistics, Data Analytics and Data Management, and regularly with Clinical Development, Clinical Operations, Medical and Safety Monitoring, Regulatory, Finance and external vendor partners.