Director, Clinical Supply Lead (CSL)
Bristol Myers Squibb
8 hours ago
Remote friendly (Princeton, NJ)
United States
Operations
Director, Clinical Supply Lead (CSL)
Key Responsibilities
- Lead TA-level intake and planning for new studies/assets and major protocol changes (IRT awareness, comparator needs, CMC-driven supply requirements) in coordination with the Clinical Supply Team Lead (CSTL).
- Provide matrix leadership to oversee and 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; empower team members and communicate decisions to both 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 the primary clinical supply chain contact for the assigned compound and associated studies; lead global supply strategy communications as appropriate.
- Resolve conflicts, trade-offs, and risks; drive adherence to standardized processes/playbooks, escalation pathways, and governance expectations.
- Develop integrated cross-functional strategies, resourcing, and implementation plans to ensure continuous investigational product supply aligned with Project Team priorities.
- Align functional 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 (accounting for country and logistics timelines).
- Provide input for program-level planning and distribution planning; ensure alignment between project strategy, CSC staffing resources, and tactical supply execution.
- Review study assumptions, monthly enrollment projections, and CSC staffing forecasts with CSC leadership to ensure alignment.
- Execute/lead CSL processes and drive continuous improvement using asset/study performance data and KPIs; proactively address shortfalls and enhance planning capabilities.
- Partner with GLS and CSC planning functions to ensure supply reliability and logistics coordination.
- Ensure early visibility of emergent changes (e.g., protocol amendments, enrollment escalations, site activations, country expansions) and coordinate timely CSC response.
- Escalate unresolved issues as needed for CSC LT visibility.
- Support budget inputs and tracking for assigned assets/studies in coordination with Clinical Supply Product Budget Management & Sourcing (CSBS).
Qualifications & Experience
- Bachelor’s degree in supply chain, Pharmacy, Life Sciences, Engineering, or related field.
- 12+ years of 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.
- Ability to collaborate with and influence cross-functional teams.
- Strong understanding of investigational product supply, clinical study operations, and 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).
- Portfolio-level planning or multi-study coordination experience.
- Excellent cross-functional negotiating skills.
Compensation & Benefits (explicitly stated)
- Starting compensation range (FTE): US $198,070–$240,011 (locations listed in posting).
- Incentive cash and stock opportunities may be available (based on eligibility).
- Health coverage: medical, pharmacy, dental, vision.
- Wellbeing support programs and EAP.
- Financial protection: 401(k), disability, life/accident insurance, supplemental health, travel protection, legal support, survivor support.
- Paid Time Off: flexible time off (unlimited, with manager approval, for US Exempt employees) or 160 hours annual paid vacation for certain categories; includes paid national holidays and additional time off based on eligibility.
Key Responsibilities
- Lead TA-level intake and planning for new studies/assets and major protocol changes (IRT awareness, comparator needs, CMC-driven supply requirements) in coordination with the Clinical Supply Team Lead (CSTL).
- Provide matrix leadership to oversee and 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; empower team members and communicate decisions to both 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 the primary clinical supply chain contact for the assigned compound and associated studies; lead global supply strategy communications as appropriate.
- Resolve conflicts, trade-offs, and risks; drive adherence to standardized processes/playbooks, escalation pathways, and governance expectations.
- Develop integrated cross-functional strategies, resourcing, and implementation plans to ensure continuous investigational product supply aligned with Project Team priorities.
- Align functional 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 (accounting for country and logistics timelines).
- Provide input for program-level planning and distribution planning; ensure alignment between project strategy, CSC staffing resources, and tactical supply execution.
- Review study assumptions, monthly enrollment projections, and CSC staffing forecasts with CSC leadership to ensure alignment.
- Execute/lead CSL processes and drive continuous improvement using asset/study performance data and KPIs; proactively address shortfalls and enhance planning capabilities.
- Partner with GLS and CSC planning functions to ensure supply reliability and logistics coordination.
- Ensure early visibility of emergent changes (e.g., protocol amendments, enrollment escalations, site activations, country expansions) and coordinate timely CSC response.
- Escalate unresolved issues as needed for CSC LT visibility.
- Support budget inputs and tracking for assigned assets/studies in coordination with Clinical Supply Product Budget Management & Sourcing (CSBS).
Qualifications & Experience
- Bachelor’s degree in supply chain, Pharmacy, Life Sciences, Engineering, or related field.
- 12+ years of 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.
- Ability to collaborate with and influence cross-functional teams.
- Strong understanding of investigational product supply, clinical study operations, and 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).
- Portfolio-level planning or multi-study coordination experience.
- Excellent cross-functional negotiating skills.
Compensation & Benefits (explicitly stated)
- Starting compensation range (FTE): US $198,070–$240,011 (locations listed in posting).
- Incentive cash and stock opportunities may be available (based on eligibility).
- Health coverage: medical, pharmacy, dental, vision.
- Wellbeing support programs and EAP.
- Financial protection: 401(k), disability, life/accident insurance, supplemental health, travel protection, legal support, survivor support.
- Paid Time Off: flexible time off (unlimited, with manager approval, for US Exempt employees) or 160 hours annual paid vacation for certain categories; includes paid national holidays and additional time off based on eligibility.