Director, Clinical Supply Lead (CSL)

Director, Clinical Supply Lead (CSL)

Responsibilities:
- Lead TA level intake and planning for new studies/assets and major protocol changes (including IRT awareness, comparator needs, and CMC-driven supply requirements) in coordination with CSTL.
- Provide matrix leadership to coordinate intra-study CSLs, TSMs, and other CSC team members based on capacity, expertise, study tiering, and relevant data.
- Establish and maintain a decision-making framework; communicate decisions at team and governance/executive levels.
- Coach and hold accountable the asset matrix team; develop and execute clinical supply strategies for assigned assets/studies.
- Serve as primary Clinical Supply Chain contact for assigned compounds/studies; lead global supply strategy communications with the study team as needed.
- Resolve conflicts, trade-offs, and risks for assigned compounds/studies.
- Drive adherence to standardized processes/playbooks, escalation pathways, and governance expectations; recommend improvements.
- Lead cross-functional strategies, resourcing, and implementation plans to ensure continuous investigational product supply aligned to Project Team priorities.
- Align execution plans and resources with approved supply strategies, trial priorities, and timelines.
- Oversee development of supply forecasts for complex studies; monitor inventory and drug utilization vs. forecast (country requirements and logistics timelines).
- Provide input for program-level planning and distribution planning; ensure alignment between project strategy, CSC staffing, and tactical supply execution.
- Review assumptions, monthly enrollment projections, and CSC staffing forecasts; align with CSC leadership.
- Design/lead CSL processes; drive continuous improvement using asset/study performance data and KPIs; take proactive actions to address shortfalls and improve planning.
- Partner with GLS and CSC planning functions to ensure supply reliability, logistics coordination, and issue resolution.
- Ensure early visibility of emergent changes (protocol amendments, enrollment escalations, site activations, country expansions) and coordinate timely CSC response.
- Escalate unresolved issues to CSC LT as a hot topic.
- Support budget inputs and tracking for assigned assets/studies with CSBS.

Qualifications:
- Bachelor’s degree in supply chain, Pharmacy, Life Sciences, Engineering, or related field.
- 12+ years’ experience in clinical supply chain, clinical operations, technical operations, or related fields.
- Demonstrated experience in planning, study support, forecasting, or operational leadership in a GxP environment.
- Proven ability to collaborate with and influence cross-functional teams to achieve clinical supply goals.
- Strong understanding of investigational product supply, clinical study operations, and functional interfaces (CMC, Regulatory, Quality, GDO).
- Proven ability to allocate resources, balance workload, and lead cross-functional issue resolution.
- Strong analytical skills interpreting planning data, operational metrics, and dashboard insights.
- Ability to lead through influence, support change adoption, and maintain operational discipline.
- Ability to coach, engage, and develop team members.
- Experience managing change in a dynamic, complex environment.

Preferred Qualifications:
- Experience managing clinical supply chain professionals.
- Experience with supply planning or S&OP processes (CD&OP desirable).
- Familiarity with digital supply chain tools (e.g., IBP, Lighthouse, Control Tower, CASSA).
- Prior experience supporting portfolio-level planning or multi-study coordination.
- Excellent cross-functional negotiating skills.