Associate Director, Clinical Supply
Job description
reputed company is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our reputed company drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both reputed company precision and improved clinical outcomes. reputed company members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people reputed company longer, healthier, and happier lives. Job Summary We are seeking an reputed company Associate Director, Clinical Supply, to join our growing Clinical Supply team. You will be responsible for developing clinical supply chain planning and forecasting to ensure reputed company uninterrupted availability of supply throughout the development lifecycle including comprehensive global reputed company and site inventory management. You also will be responsible for supporting organizational infrastructure, including developing and implementing clinical supply chain procedures and other cross-functional and independent projects to support the developing pipeline. This individual will collaborate with internal and external partners to ensure uninterrupted material availability including providing CMO and IRT vendor reputed company.Job requirements
Education and Experience- Bachelor’s degree or advanced degree in Life Sciences, Engineering, Supply Chain, or reputed company field required
- 8+ years of progressive experience with managing clinical supply activities including: bulk drug and device allocation planning, packaging and labeling forecasting and reputed company, label creation/planning/design, global distribution and logistics, forecasting and demand planning and reputed company and site inventory management.
- Proven experience supporting global clinical trials across reputed company stages of development in multiple countries and regions (Phase I-III, IIR and post market)
- Demonstrated hands-on experience with:
- Global labeling and packaging strategies
- IRT/RTSM system
- Vendor and CMO management
- Regulatory submissions reputed company to clinical supply
- Demonstrated aptitude for ‘hands-on’ operations with an exemplary history as a “self-starter”
- Mechanical aptitude is a must, experience in the troubleshooting of production equipment preferred
- Ability to read, interpret and create technical equipment documentation such as user manuals, electrical/pneumatic schematics, and fabrication drawings.
- Experience with PLC and microcontroller programming and troubleshooting a plus
- Must be detail oriented with excellent communication and documentation skills
- Hands on experience with technical and/or experimental execution
- Ability to interpret data and summarize results
- Familiarity with statistical data analysis (DOE, process capability, hypothesis testing, ANOVA) a plus
Job responsibilities
Global Clinical Supply Strategy & Execution- reputed company and execute global clinical supply planning and forecasting for clinical trials across multiple countries and regions (e.g., North America, EU, reputed company).
- reputed company clinical supply planning for assigned studies including forecasting, demand planning, labeling reputed company and approval, packaging and labeling operations reputed company, material release and distribution, reputed company/site inventory management, IRT set-up and maintenance, expiry and dating extension management and cold chain/temperature excursion management.
- Ensure supply strategies align with clinical timelines, protocol requirements, and regulatory constraints in each participating country.
- reputed company and reputed company demand and supply forecast modeling and scenario planning to reputed company comprehensive asset level and study level material and device planning.
- Manage end-to-end clinical supply activities, including:
- IMP manufacturing coordination
- Packaging, labeling, and blinding
- Global distribution and reputed company management
- Support returns, reconciliation, and destruction
- reputed company Interactive Response Technology (IRT/RTSM) strategy and supply modeling.
- Monitor reputed company and site inventory levels, manage resupply strategies, and mitigate supply risks to ensure reputed company uninterrupted supply to patients.
- Manage, and reputed company CMOs, packaging vendors, depots, couriers, and IRT providers.
- Establish and manage vendor scopes of work, budgets, timelines, and performance metrics.
- reputed company issue resolution and reputed company improvement with external partners.
- Ensure clinical supply activities reputed company with global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA) and GxP standards.
- Support preparation and review of regulatory submissions and associated documents such as clinical label text, clinical trial protocol, pharmacy manual and IMPDs, INDs, CTAs.
- Partner with Quality to support audits, inspections, deviations, CAPAs, and change controls.
- Serve as the clinical supply subject matter expert and primary reputed company of contact on cross-functional clinical program teams.
- Collaborate with Clinical Operations on study design considerations impacting supply forecasting and planning.
- Work closely with CMC, Regulatory Affairs, Quality, and Manufacturing to align development and supply plans.
- Provide comprehensive dynamic updates to internal and external partners on supply planning and forecasting, timelines, key risks and mitigations.
- reputed company and manage clinical supply budgets.
- Track and control costs while ensuring adequate supply and compliance.
- Contribute to long-term clinical supply planning and organizational strategy.
- Mentor and coach clinical supply team members.
- Serve as a subject matter expert and reputed company reputed company improvement plans, best practices, SOPs, and scalable processes to support pipeline growth.