Senior Director, Supply Chain Management

Position Summary:

Upstream is seeking a Senior Director, Supply Chain Management provide leadership in the development and execution of clinical supply chain as well as support the readiness for commercial launch activities. The successful candidate will bring a history of successfully managing complex global clinical study supply chains and late-stage organizational development. This key role will be instrumental in developing supply strategies, forecasting, infrastructure, and end-to-end supply chain activities. As part of the clinical study management teams, the successful candidate will partner with Clinical Operations to align and execute on demand assumptions throughout the entirety of studies and coordinate clinical supply demand requirements with CMC, distribution, and third-party partners to ensure seamless continuity of (re)supply. This person will collaborate with cross functional stakeholders such as Finance, Regulatory Affairs, Information Technology, and Quality Assurance to support all aspects of organization supply activity. This role requires critical thinking and communications skills in a fast-paced environment to effectively engage with all stakeholders, from senior leadership through to working teams.

Key Responsibilities:

• Develop and achieve alignment on end-to-end supply strategies and effectively communicate to internal stakeholders and external partners to operationalize and meet performance requirements
• Lead and execute global clinical study supply plan to ensure timely (re)supply delivery of drug product to sites/patients
• Champion the evolution of the Clinical Demand & Operations Planning (CD&OP) process to drive transparency and successful investigational product supply to study patients
• Pro-actively anticipate and identify real and potential supply risks, develop risk mitigation strategies as necessary and align across functionally to maximize mitigation efforts
• Advance clinical drug product supply related activities to ensure organizational compliance and seamless supply to patients including manufacturing planning, IRT implementation/execution, packaging operations, distribution, shelf-life management, global cold chain logistics, temperature excursions, inventory optimization, and returns management
• Define and mature the development and execution of phase appropriate supply chain cGMP processes and related documentation/SOPs to support GxP compliance
• Create, monitor, and ensure transparency to key performance metrics and continuous improvement efforts
• Build scalable functional capabilities to further develop infrastructure in support of supply chain operational maturity and organizational growth
• Support global regulatory filings and related activities related to supply chain activities
• Provide insights into the development of Sales & Operations Planning (S&OP) programs to drive cross functional alignment
• Collaborate cross-functionally and influence commercial launch readiness supply chain strategies and execute in such areas as inventory and planning systems and tools, packaging/tamperproof requirements, and multi-channel distribution strategies
• Achieve compliance with the Drug Supply Chain Security Act (DSCSA)
• Track performance to budgets as well as project supply demands fiscal impact
• Travel to partner sites to oversee critical activities (~10% of the time)

Qualifications:

• Demonstrated success in building and scaling supply chain operations in a global pharmaceutical organization from development-stage through commercial launch, large molecule experience preferred
• Bachelor’s degree in supply chain management, sciences, business or related field and 12 years of relevant biopharmaceutical industry experience or an advanced degree with 10 years
• Ability to operate both strategically and tactically in a fast-paced environment, managing and influencing external partners
• Proven experience in global clinical and commercial launch supply management
• Effective communication skills both cross-functionally and at the executive level
• Excellent collaboration, mentoring, and influencing skills
• Strong understanding of supply chain clinical and commercial regulatory requirements and cGxP quality systems (including, but not limited to GMP, GDP, and GCP)
• Proficient knowledge of SharePoint, Veeva, eTMF management, Smartsheet’s, Visio, supply planning tools, IRT systems, MS Office (Excel, PowerPoint, Visio, Project, etc.)
• Transformational change management skills to foster organizational growth

About Upstream Bio:

Upstream Bio is a clinical-stage biotechnology company, based in Waltham, MA, developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. The Company is developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. The Company has evaluated this highly potent monoclonal antibody in separate Phase 2 trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and an ongoing Phase 2 trial in chronic obstructive pulmonary disease (COPD). Upstream Bio’s team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. To learn more, please visit www.upstreambio.com.

Compensation

Target Salary Range: $239,216 -$292,375

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.