Associate Director, Clinical Supply Planning & Business Process Management

Cytokinetics is a late-stage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

Job Purpose

The Associate Director Clinical Supply Chain will develop and formulate supply chain strategies meet project deliverables solve business problems and drive improvements within Global Clinical Supply Chain (GCSC) as well as the Cytokinetics enterprise. This position includes all elements of the clinical supply planning from translating protocol design to executable demand forecasts through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide. This role ensures the timely compliant delivery of high-quality clinical trial materials and investigational medicinal products through cross-functional collaboration efficient resource management and vendor oversight. The incumbent will also drive innovation and continuous improvement within clinical supply chain processes while ensuring alignment across the organization as well as maintaining regulatory compliance in order to meet corporate objectives.

Key Responsibilities

Supply Chain Planning

• Develop and maintain end-to-end supply plans for clinical programs including demand forecasting production planning and inventory strategies across depots and external CDMOs.

• Translate clinical development forecasts into executable supply strategies (production plans) that align with CMC Clinical Operations Quality and Regulatory milestones.

• Lead cross-functional scenario planning and risk assessments to ensure uninterrupted supply across all stages of clinical supply.

• Responsible for leading Global Clinical Supply Chains planning cycle and inventory control which includes CDOP (Clinical Development Operations Planning) and Clinical Supply & Operations Planning.

Inventory Control

• Implement fit for use inventory control strategy to optimize clinical supply positions across the network while minimizing expiry and obsolescence.

• Accountable for GCSC inventory classification and control procedure(s) ensuring blinding is maintained at each applicable product stage.

• Maintain full lot-level traceability and batch genealogy across raw materials intermediates drug substance drug product and finished goods proactively manages lot expiry and extension memo acquisition to ensure supply continuity.

Systems & Business Process Management

• Leads the implementation and optimization of advanced planning systems improving forecast accuracy visibility and decision-making across the supply chain serves as the organizations primary point of contact for vendor related break/fix enhancements overall functionality and alignment with IWRS instances.

• Primary point of contact within Global Clinical Supply Chain for supply impacting IWRS issue capture triage and resolution Partners with Biostats and GCSC to drive alignment on corrective and/or preventative actions ensuring data integrity and operational continuity for supply impacting change(s).

• Responsible for standardizing and maintaining tiered performance metrics across GCSC & external partners functional point of contact for GCSC owned data & metric control plan.

• In partnership with GCSC study leads manages QMS related records e.g. Change Control Impact Assessments Risk Assessments Deviations Corrective and Preventative Actions.

• Responsible for GCSC training curricula as well as owning and authoring applicable SOPs Forms and Work Instructions (Standard Work) Partners cross-functionally to ensure alignment with Commercial and Development standards.

• Owns GCSC tiered framework for cross-functional communication problem solving and visual control - scoped to increase the speed of issue identification resolution and overall cross-functional execution across our organization.

• Leads and facilitates GCSC project initiatives as required.

Skills:

• Strong leadership and business acumen with a track record of driving improvements cross-functionally with an entrepreneurial mindset.

• Exceptional problem-solving decision-making and project management abilities.

• Excellent written and verbal communication skills with the ability to effectively present complex information to diverse audiences.

• Advanced proficiency in change management and cross-functional collaboration.

Preferred:

• Experience with oral solid dose and associated manufacturing/packaging and regulatory documentation.

• Familiarity with IRT/IWRS/ERP systems capabilities and their operational requirements.

Qualifications

• MS or BS in chemistry pharmaceutics or a related discipline; advanced degree preferred.

• 8 years manufacturing experience in biotech/pharmaceutical industry.

• 5 years Operations Management experience

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Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

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Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer