Executive Director, Supply Chain, Logistics, and Packaging

CMC (700) · Berkeley, California
Department CMC (700)
Employment Type Full-Time
Minimum Experience Experienced

Chinook Therapeutics Job Description: 

Executive Director, Supply Chain, Logistics, and Packaging


Company:

 

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

 

Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.


Position:

 

The Executive Director, Supply Chain and Packaging, is an end-to-end global supply chain leader that inspires teams while providing expertise in a fast-paced biotech environment. The Executive Director provides managerial leadership to the Supply Chain & Logistics and Packaging groups and works collaboratively with technical product leads, program management, CMC, Clinical Operations, Regulatory, Quality Assurance, New Product Planning, and Commercial to develop strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes all elements of the global supply chain from clinical demand planning through label design, production planning, transportation, inventory management and distribution of clinical supplies at clinical sites worldwide. The Executive Director is also accountable for building the supply chain capabilities and infrastructure to commercialize products ensuring a robust, resilient and secure flow of inventory to patients through the product life cycle.

 

The position is remote and reports to the Sr Vice President, CMC and Technical Operations.

 

 

 Responsibilities include:

 

  • Continues building and provides leadership, mentorship, and direction to the Supply Chain, Logistics & Packaging group.
  • Designs and owns the end-to-end business processes for clinical & commercial supply chain management.
  • Oversees labeling/distribution/packaging design contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement for clinical and commercial.
  • Ensures excellent execution and validation of all logistics and 3rd party storage activities including full range of compliance requirements (Health Authorities, Tax, Customs, etc).
  • Ensures that IT systems are implemented to enables those processes in an integrated manner including ERP and serialization.
  • Identifies risks and assumptions in plans, anticipates issues, and plans for contingencies. Removes obstacles to move work forward and/or to get efforts back on track.
  • Defines long range plans in alignment with both product and network strategies - determine what mix of inventory, capacity (dual sourcing) or lead time buffers are needed to secure supply and manage upside and downside risk.
  • Working closely with CMC, Finance and Legal, leads development/clinical and commercial contract negotiations with manufacturing and testing contract organizations.
  • Manages product switches and transfers in alignment with the product strategy, including clinical to commercial transitions.
  • Develops detailed plans to launch commercial products as quickly as possible following regulatory approval while managing expiry risk.
  • Ensures alignment between CMC/Tech Ops, New Product Planning, Commercial, Quality, and Finance regarding commercial volumes inventory spend and risk (supply & financial).
  • Maintains high quality and efficiency standards.
  • Willing and able to develop and nurture productive business relationships with colleagues, partners, suppliers, contractors, leaders and subordinates.
  • Contribute to the development and maintenance of a positive team-focused company culture. Proactively seeks to develop team members.


Education, Experience, and Skills:

 

  • MS/Ph.D. in life science or engineering and at least 15+ years of related experiences in the biotechnology or pharma industry.
  • Energetic, flexible, collaborative, and proactive leadership and management skills to grow and develop the Supply Chain & Packaging Team.
  • Proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stake-holders.
  • Strong planning and tracking skills, able to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
  • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
  • Able to work in a fast-paced and dynamic environment with competing priorities and prioritize driving projects forward and meeting program/project deliverables.
  • Must possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13.
  • Flexible and adaptable in constantly changing environments and growing organization; Able to lead and move organizations forward with environmental and organizational ambiguity. Possesses a bias for action and displays a sense of urgency.
  • Proven experience with regulatory submissions (IND, BLA, MMA, etc.), ideally for products which were ultimately approved for commercial distribution. Experience with taking supply chain organization through commercial transition preferred.
  • Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes.
  • Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships with lean resources.
  • Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions.
  • Highly skilled in the ability to work with ambiguity and complexity. Can continuously modify options and solutions across all levels of the organization in alignment with environment, company goals, culture, and expectations.


Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.  We respect and value different experiences and viewpoints.  We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

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  • Location
    Berkeley, California
  • Department
    CMC (700)
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced