Job Description
Description
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA®(tenapanor) and XPHOZAH® (tenapanor), as well as early-stage pipeline candidates.
The VP, Global Supply Chain will "Own" the supply chain process at Ardelyx. The individual will work within a multidisciplinary team, and directly impact strategy and timing of clinical supply chain activities, drug substance manufacturing, and drug product production. The qualified individual will have a track record of accomplishment in strategic planning and operation supply chain management, CMO selection and management, third-party logistics and project planning & coordination including leading Ardelyx's cross-functional teams for commercial product launch. You will have the opportunity to directly influence program strategy and build new infrastructure within Ardelyx from the ground up, including assuming responsibility for direct reports.
Essential Functions:
- Design, lead and implement a comprehensive global supply chain strategy at Ardelyx. Manage and improve the Sales & Operations Planning Process at Ardelyx.
- Partner with Clinical Operations and other internal stakeholders to create and test clinical supply assumptions.
- Execute supply chain direction, and resource requirements sufficient to deliver robust supply solutions
- Direct the strategic Global Supply and Demand Planning efforts and facilitate Sales & Operation Planning process.
- Drive global forecast planning and inventory management of all drug products in the pipeline, both internal and acquired through commercial agreements. In addition, provide global Forecast planning and inventory control of all intermediates and final products.
- Oversee product purchasing and planning at contract manufacturing and logistic suppliers. Includes establishment and oversight of rolling forecasts for clinical and commercial products, and coordination of clinical packaging, logistics and labeling operations for drug products.
- Oversee and manage the supply chain group, and communicate both internally and externally the master production schedules for drug products, including a master production forecast for all strategic partners
- Manage and improve key Supply Chain interfaces with CMC, Clinical Operations, Quality Assurance, Regulatory Compliance, Sales & Marketing, and FP&A such that inventory demands, and forecasts align at both the operational and revenue levels.
- Participate in strategy discussions to ensure that decisions align with agreed upon business direction and processes.
Essential Capabilities:
- Develop and prepare long and short-range global supply plans, including strategic make vs. buy analyses and capital investment plans.
- Establish and implement inventory policy and materials risk mitigation strategies.
- Review and execute purchase orders for commercial API and finished products as approved and agreed.
- Act as primary point of contact with 3PL companies and actively manage this relationship to ensure scheduled delivery goals are met
- Serve as Subject Matter Expert for supply and distribution on commercial launch teams and other forums as appropriate and assigned.
- Develop and manage annual operating budgets and assure maximum functional area output with minimum cost and resource burden.
- Provide expertise and oversight on the development, review, approval, and follow-through of investigational new drug application technical sections of regulatory submissions as they relate to shipping, and distribution.
- Ensure that supply chain follows all supply and distribution corporate policies and that all Company products abide to lawful and accepted practices of supply and distribution, including import and export of investigational and commercial pharmaceutical products.
- Initiate and oversee global supply chain business transformation and productivity initiatives in a manner that systematically improves supply chain operational excellence and delivers superior business results.
- Provide leadership, mentoring, training, coaching, and sustain all the Continuous Improvement Initiatives of the company.
- Lead the development of productivity and quality metrics/measurements (KPI's) to ensure optimum efficiency, quality, and utilize metrics to drive supply chain operational improvements.
- Lead the identification and assessment of business-appropriate ERP system for Supply Chain and ensure timely and cost-effective implementation.
- Responsible for the Applications and Systems that spans Ardelyx like ERP's, Serialization, Master Data/Product Lifecycle Management (PLM).
- Ensuring we have a vision for ERP and PLM that is aligned to our long-term enterprise goals and objectives and overseeing the development of a global strategy to support that vision
- Staying abreast of future technology trends that will impact ERP and PLM and ensuring these are factored into our business and ERP/PLM plans
- Develop annual goals that are aligned to Ardelyx's goals that ensure we're focused on continuous improvement and business value
Position Requirements:
- Bachelor's or Master's degree in Biology, Chemistry, Engineering or related technical field and 10 years relevant experience in supply chain management and/or project management within a commercial-stage pharmaceutical or biopharmaceutical environment
- Track record of skilled management of third-party contractors; can motivate and inspire action in the absence of direct reporting relationships
- Demonstrated success in bridging the operations of various internal groups (API, pharmaceutics, QA, Regulatory, Clinical)
- Proficient knowledge of Microsoft Excel, PowerPoint and Project software required; experience in serialization a plus
- Demonstrated experience in inventory management and forecasting
Ability to thrive in a multi-tasking and complex environment; responds with humor to challenging situations and ambiguity
The anticipated annualized base pay range for this full-time position is $258,660-$316,140. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous match, 12 weeks of paid parental leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision) and basic life insurance and disability, as well as up to 10 hours of paid vacation per month, and at least 10 paid holidays.
Ardelyx is an equal opportunity employer and will provide reasonable accommodations for those unable to be vaccinated who qualify for exemption in accordance with applicable law.
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Date Posted
12/04/2023
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