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Job Title: Senior Distribution Manager

Department: CMC

Location: Miami/Remote

Overview of Role:

We are seeking an experienced pharmaceutical supply chain professional to join the CMC team and support building and executing the distribution strategy for clinical development and commercialization preparations.

The Senior Distribution Manager will be responsible for managing the movement of all of Summit owned products globally (including but not limited to bulk drug substance, investigational dug product, commercial drug product, pre-clinical material as well as ancillary or raw materials) with a key deliverable of selecting and onboarding the required 3PL partner(s) to support global commercialization plans

Building strong, productive relationships with key internal stakeholders is a central requirement, alongside leading process improvement, vendor management and performance tracking initiatives.

The candidate must have demonstrated effective collaborative skills to work across a wide range of product movements, ideally within a biotech setting and for temperature sensitive products.

Summit is a global company; overseeing global activities across multiple time zones and as such may require flexibility in working hours at times.

This person will provide vision, strategy, leadership, and direction for supply chain operations to achieve and maintain the highest standards of quality, regulatory compliance, customer satisfaction, delivery & service, to accomplish business goals at competitive costs. The Senior Distribution Manager will create and meet short- and long-term business goals to support our stakeholder/customer and business requirements through direct or indirect management of material supply chain operations. This person will lead and support key strategic and tactical initiatives to optimize performance of Supply Chain.

Role and Responsibilities:

  • Shipping Planning & Forecasting and execution
    • Develop and maintain accurate distribution forecasts for quarterly shipment plans based on stakeholder feedback
    • Collaborate with cross-functional teams to ensure alignment of distribution plans within timelines and milestones
    • Budget forecasting and spend analysis to be provided to finance for all operational plans
    • Fulfil shipment requirements for internal stakeholder’s requirements
  • Vendor Management
    • 3PL vendor selection and relationship & contract Management: work with carriers, freight forwarders, and shipping lines to secure favorable rates and reliable service
    • Customs Broker Management: Manage existing partnerships and work with relevant sales & operations teams to identify opportunities where new broker partnerships need to be created
    • Monitor vendor performance, adherence to timelines, and quality standards
  • Process Optimization
    • Implement and maintain robust processes within Quality Management System to support operations
    • Distribution Network: Optimize our distribution network by identifying the most efficient transportation modes and carriers, negotiating contracts and optimizing routes including the identification of relevant distribution centers
    • KPI & Analytics: Define and report monthly KPIs to minimize compliance risks, optimize logistical spend and drive overall team performance
    • Integrate cross functional requirements into an efficient process for raising and overseeing shipments
  • Regulatory Compliance
    • Stay up to date on relevant regulatory requirements and guidelines related to effective supply chain management
    • Compliance with International Trade Regulations: Responsible for maintaining compliance with international trade regulations. This includes understanding and adhering to customs requirements, import/export laws, and other relevant regulations. Act as an internal expert to support Importer of Record responsibilities for US entities.
  • Risk Management
    • Identify potential risks and challenges in the supply chain and develop mitigation plans
    • Proactively address issues that may impact the availability of materials
  • Communication and Collaboration
    • Foster effective communication and collaboration with internal stakeholders, including Clinical Operations, Commercial, Regulatory Affairs, Quality Assurance, Finance and other relevant departments
    • Participate in project team meetings to provide updates on supply chain status and address any issues or concerns as needed
  • All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

  • Bachelor’s degree in a relevant scientific or business discipline; advanced degree preferred.
  • Minimum of 8 years’ experience in supply chain operations with 3 years’ experience in a management role at a pharma, biotech, or contract development and manufacturing organization (CDMO)
  • Experience in selecting and overseeing 3PL partners for pharmaceutical commercial launch
  • Proficiency in relevant software applications (e.g., Microsoft Office, ERP, supply chain modelling systems & serialization)
  • Demonstrated track record of successfully managing distribution within complex international pharmaceutical supply chains
  • Broad understanding of regulatory, GDP, GMP requirements for medicinal products
  • Solid understanding and experience in writing and optimizing processes
  • Project management skills, tools, principles, and applications
  • Expertise in outsourcing and supplier relationship management
  • Proficiency with planning and forecasting tools
  • Demonstrated experience in building out a distribution network for commercial medicinal products
  • Comfortable interacting with all levels of the organization, customers, and suppliers.
  • Able to work with abstract global problems
  • Nimble in a highly dynamic and agile organization where changing priorities are the norm.
  • Intuitive with well-honed interpersonal and communication skills
  • Organized and demonstrates effective team leadership
  • Effective with global workgroup associates
  • A promotor of inclusion and collaboration
  • Able to work independently
  • Able to handle multiple projects simultaneously while maintaining high-quality results
  • Capable of providing and implementing innovative solutions to unique and pressing situations
  • Aware and compliant with FDA, EMA, PMDA regulations and requirements for functioning under GMP, GCPs, Annex 13, and EU CT Directive
  • Able to demonstrate a fundamental knowledge of drug development process
  • Technically proficient in industry standard technology and/or available software, processes, and industry trends to streamline and or improve efficiencies
  • Knowledgeable of and compliant with SOPs, Change Controls, Deviations, Investigations and CAPAs

The pay range for this role is $160,000 to $175,000 annually. 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. 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. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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.

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