Director Clinical Supply Chain Operations

Location:  remote, United States Category: Supply Chain

Description

SUMMARY

The Director, Clinical Supply Chain Operations is a newly created position which will focus on developing an end to end clinical supply chain operating model.  This role has a global, end to end remit and serves as the global business process owner for Clinical Supply Chain Operations.   This department operates within the Global Supply Chain organization.  With a heavily virtual global supply chain network, clinical supply chain execution and visibility is currently challenged.  This leadership role will be tasked with building an integrated operating model with close collaboration with cross functional stakeholders.  You will be offered an opportunity to work in a very entrepreneurial environment where new ideas are welcomed and embracedIdeal candidate will have a passion for leading an agile team while driving change, transformation while leading an agile clinical supply chain operating model.  In summary, this role is where Clinical Supply Chain expertise leads transformational digitization for end to end integration.

RESPONSIBILITIES

  • Oversees demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, return or destruction and global distribution logistics
  • Act as a key interface between the CMC and Clinical Operations teams
  • Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
  • Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time
  • Managing clinical labeling including the support of label design, translation and production
  • Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies
  • Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors.
  • Regularly monitor drug expiration; initiate inventory release and re-supply with the IXRS, serving as the unblinded inventory manager.
  • Prepare, forecast and manage the budget and ensure department adhere to the approved budget
  • Develop team and provide ongoing coaching to support their individual growth
  • Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, and Manufacturing functions, to ensure effective internal stakeholder collaboration
  • Develop and maintain Clinical Supply Chain SOPs/Work Instructions
  • Lead continuous improvement programs and/or compliance projects that benefit or impact the clinical supply chain business process
  • Lead change management process and controls for department
  • Compliance and performance monitoring of Clinical Supply Chain Operations
  • Lead the department’s digitization initiative as a change agent
  • Leverage systems and technology to simplify, improve productivity, and enable predictivity of Clinical Supply Chain Operations
  • Direct responsibility of Clinical Supply Chain Operations team, including people and talent management
  • Budget responsibility for department
  • Collaborate cross functionally and obtain indorsement of clinical program execution plans
  • Monitor internal and external industry trends

 

SCOPE AND COMPETENCIES

The Clinical Supply Chain Operations group is uniquely positioned as a key touch point across the entire organization, from R&D, to Clinical, through to Commercial.  This role has the opportunity to impact the collaboration of Clinical Supply Chain both downstream and upstream across various business categories.  Core competencies for this role include:

  • Demonstrated ability to communicate and collaborate cross functionally while influencing stakeholders in a matrix environment effectively
  • Ability to exercise effective decision making through proper planning and execution
  • Agility and demonstrated ability to embrace dynamic change in a rapidly evolving environment
  • Results-driven, take initiative and ownership to accomplish work
  • Passion of continuous improvement while embracing innovative ideas
  • Exhibit coaching skills to develop team
  • Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables
  • Innate sense of organizational awareness, ability to connect the dots to understand all the interdependency and big picture with an ability to articulate department vision

EDUCATION AND EXPERIENCE

  • Master’s degree in Supply Chain, Business Operations, Engineering, or equivalent
  • 10 – 15 years biopharma experience, in a complex, virtual, clinical/commercial supply chain environment
  • APICS certification desirable
  • 5 – 10 years experience as a change agent within supply chain operations
  • Willingness to take the first steps and inspire others to follow
  • Track record of deep diving into new domains
  • Ability to view obstacles as triggers for change with an innate ability to execute in a fast and furious manner
  • Comprehensive understanding of supply chain relevant ERP systems and supply chain partner integration requirements
  • Significant Clinical Supply Chain experience with subject matter expert level knowledge
  • Demonstrated, deep understanding of end to end global supply chain processes
  • Experience in deploying and reporting KPIs with leading indicators
  • Working knowledge of import / export operations
  • Strong communication, presentation, decision making and negotiation skills
  • Ability to work in a global, matrix organization
  • Excellent people management skills with multicultural background and a strong track record of developing talent and organizational capability
  • Strong intercultural skills to facilitate successful interactions in international markets

CONTACTS

  • Global Supply Chain, Global Logistics, Information Management, Clinical Operations, Global Compliance & Ethics, Quality Assurance, Business Process Improvement, Supply Chain system vendors

 

SUPERVISOR RESPONSIBILITY

This position will start with at least 6 direct/indirect reports.  Effective people management and talent development experience required with a focus on embracing a culture of open communication and proactive feedback with staff, peers, and management.

 

CAREER DEVELOPMENT

  • Strong collaboration in creating a culture of high performance
  • Transparent communication with stakeholders and customers
  • Lead department in a global, harmonized manner, with execution in a decentralized manner
  • Demonstrated change agent with performance improvement measurements clearly defined and aligned across organization
  • Demonstrated ability to build trust and effective relationships with peers and stakeholders
  • Consistently deliver business results through timely and quality decision making

 

WORK ENVIRONMENT/PHYSICAL DEMANDS

The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.  Willingness for high-level of regional and international travel.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated.