Summit Therapeutics

Summit Therapeutics

Associate Director, Clinical Supplies-Global Planning & Operations

Palo Alto, CA (US) · Director

Sponsorship not specified$175k-$200kDetected 57 days ago
Data AnalysisProject ManagementStakeholder ManagementForecastingBudgetingExcelSupply ChainLogisticsRecruitingCadenceClinical TrialsGMPResearchLeadershipCommunicationCollaborationDemand Planning

About the role

  • The Associate Director of Clinical Supply provides leadership and direction to plan and execute global clinical supply activities, ensuring timely and compliant delivery of clinical trial material (CTM) and investigational medicinal product (IMP).

Responsibilities

  • Under the direction of the Director, manage clinical supply manufacturing, distribution and storage activities supporting global clinical trials and other research and development needs; coordinate, procure, and manage CTM/IMP supply for the Ivonescimab program.
  • Establish and maintain a regular review cadence for supply plans against demand forecasts and confirmed orders; lead recurring demand and supply reconciliation meetings, identify short-term constraints, and present mitigation plans.
  • Manage bulk and packaged inventory and track/reconcile inventory across manufacturing, packaging, depots, and clinical sites.
  • Coordinate upstream transport operations between suppliers and distribution warehouse(s) to support CTM/IMP supply, as needed.
  • Manage supply forecasts (creation, updates, cancellations) and communications in alignment with supplier agreements; review KPIs with suppliers and schedule regular governance/steering meetings.
  • Maintain inspection readiness through robust documentation workflows and archival of CTM/IMP supply documentation for the Trial Master File (TMF).
  • Partner with internal stakeholders and external suppliers to develop and communicate manufacturing and distribution plans, ensuring clinical supply objectives are supported.
  • Work closely with the Distribution/Logistics function to plan, document, and execute global cross-border supply strategies, including controlled substances and global trade compliance requirements.

Requirements

  • own, disseminate and amend as required.
  • Provide visibility of priorities to optimize QA/QP and regulatory release activities and support logistics and manufacturing operations, including coordination of expedited shipments when required.
  • All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Nice to have

  • Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
  • Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Skills

  • Degree in Pharmacy, Engineering other scientific/technical degree, or significant job-related experience.
  • Minimum of 8+ years of relevant pharmaceutical industry and/or contract/service provider experience (preferred).
  • Minimum 5+ years of relevant supply chain planning experience
  • Background in biological product manufacture is preferred
  • Strong understanding of cGMP requirements and regional regulatory drivers
  • Line management experience is preferred
  • This is the pay for this position
  • Pay Transparency
  • $175,000 - $200,000 USD
  • This may be different in other locations due to differences in the cost of labor.
  • The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
  • Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.

Compensation

  • $175,000 - $200,000 USD
  • Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
  • The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Equal opportunity

  • Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.
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This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.