Executive Director, Clinical Supply Chain

Revolution MedicinesRedwood City, CA
21h$265,000 - $331,000Hybrid

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Executive Director, Clinical Supply Chain provides strategic leadership and operational oversight for end-to-end clinical supply chain activities across the organization. Strategic Leadership Define and execute the global clinical supply chain strategy aligned with the company’s clinical development pipeline and long-term business goals. Establishes strategies and processes to ensure uninterrupted supply for Revolution Medicines portfolio across all phases of development. Lead and serve as subject matter expert for clinical supply chain planning, risk management, and execution of clinical supply chain activities. Build scalable processes and infrastructure to support early- through late-phase clinical programs. Strategic Planning on comparator sourcing management to ensure timely, compliant and cost-effective product availability. Effective management of clinical studies executed in conjunction with collaboration partners. Identify and implement overall clinical supply chain best practices. Clinical Supply Operations Oversee end-to-end clinical supply activities, including demand forecasting, protocol reviews, packaging, labeling, distribution, and returns. Ensure uninterrupted supply of investigational medicinal products (IMP), including RevMed and comparator products. Champions monthly Development Operations planning (DnOP) process in collaboration with PDM and Clinical Operation team members. Ensures efficient global clinical supply chain distribution networks are in place. Oversee comparator products demand and supply planning with expert level knowledge in comparator drugs and co-medications sourcing strategy Cross-Functional Collaboration Partner with Clinical Operations and Clinical Study Execution Teams (CSET) in study planning and execution. Collaborate with PDM, Quality, and Regulatory to ensure compliant manufacturing, labeling, and distribution Work closely with Finance on budgeting, forecasting, and cost optimization. Work effectively with internal and external partners to develop sound strategies, identify and mitigate risks, and resolve issues as they arise. Compliance & Quality Ensure all clinical supply activities comply with GxP, ICH, FDA, EMA, and global regulatory requirements. Expert knowledge of applicable GxP requirements and applicable regulatory guidances. Lead inspection readiness activities as required for global filings and maintain and inspection ready organization. Team Leadership Build, lead, and mentor a high-performing clinical supply chain organization. Drives for excellence in execution of agreed upon strategies. Establish clear performance metrics, development plans, and succession planning. Foster a culture of accountability, continuous improvement, and collaboration. Drives excellence in setting clear and actionable team goals.

Requirements

  • Bachelor’s degree in Supply Chain, Business, Engineering or Life Sciences with 20+ years of experience in pharmaceutical supply chain. Master’s degree (MS, MBA) with at least 18 years of experience in pharmaceutical/biotech supply chain.
  • CPIM/CSCP certifications a plus.
  • At least 5 years of experience in a leadership/supervisory role.
  • Strong knowledge and experience with cGMP operations for small molecules, end- to end supply chain and demand/supply planning.
  • Effective vendor management and oversight skills
  • Excellent cross-functional leadership skills with effective communication skills.

Nice To Haves

  • Proven leadership experience hiring, managing and developing teams.
  • Knowledge and experience with outsourced manufacturing operations. (CMO’s)
  • Effective, open and transparent communication skills (verbal and written). Strong analytical, communication and executive level reporting skills.
  • Capable of working on multiple projects/tasks and able to meet timelines.
  • Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results.
  • Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

Responsibilities

  • Define and execute the global clinical supply chain strategy aligned with the company’s clinical development pipeline and long-term business goals.
  • Establishes strategies and processes to ensure uninterrupted supply for Revolution Medicines portfolio across all phases of development.
  • Lead and serve as subject matter expert for clinical supply chain planning, risk management, and execution of clinical supply chain activities.
  • Build scalable processes and infrastructure to support early- through late-phase clinical programs.
  • Strategic Planning on comparator sourcing management to ensure timely, compliant and cost-effective product availability.
  • Effective management of clinical studies executed in conjunction with collaboration partners.
  • Identify and implement overall clinical supply chain best practices.
  • Oversee end-to-end clinical supply activities, including demand forecasting, protocol reviews, packaging, labeling, distribution, and returns.
  • Ensure uninterrupted supply of investigational medicinal products (IMP), including RevMed and comparator products.
  • Champions monthly Development Operations planning (DnOP) process in collaboration with PDM and Clinical Operation team members.
  • Ensures efficient global clinical supply chain distribution networks are in place.
  • Oversee comparator products demand and supply planning with expert level knowledge in comparator drugs and co-medications sourcing strategy
  • Partner with Clinical Operations and Clinical Study Execution Teams (CSET) in study planning and execution.
  • Collaborate with PDM, Quality, and Regulatory to ensure compliant manufacturing, labeling, and distribution
  • Work closely with Finance on budgeting, forecasting, and cost optimization.
  • Work effectively with internal and external partners to develop sound strategies, identify and mitigate risks, and resolve issues as they arise.
  • Ensure all clinical supply activities comply with GxP, ICH, FDA, EMA, and global regulatory requirements.
  • Expert knowledge of applicable GxP requirements and applicable regulatory guidances.
  • Lead inspection readiness activities as required for global filings and maintain and inspection ready organization.
  • Build, lead, and mentor a high-performing clinical supply chain organization. Drives for excellence in execution of agreed upon strategies.
  • Establish clear performance metrics, development plans, and succession planning.
  • Foster a culture of accountability, continuous improvement, and collaboration.
  • Drives excellence in setting clear and actionable team goals.
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