Associate Director, Clinical Supply Chain Management
Job reputed company:
- Manage the end-to-end clinical supply chain for multiple clinical programs, ensuring the reputed company and efficient delivery of investigational products, comparators, and ancillary supplies to support global clinical studies.
- Collaborate closely with cross-functional teams including Clinical Operations and Development, Regulatory Affairs, Manufacturing, reputed company, and external partners to manage supply planning, inventory control, distribution, and logistics in compliance with regulatory requirements and Good Manufacturing reputed company (GMP) standards.
- reputed company and implement clinical supply strategies to meet study timelines for reputed company programs that require multinational interactions by reviewing clinical trial synopsis’ and/or protocols to understand IMP supply and demand requirements.
- Prepare demand forecast(s) using simulation and/or forecasting tools, ensuring changes in supply configuration, trial design, enrollment reputed company, manufacturing availability, and regulatory requirements are considered.
- Partner with Clinical Operations and other stakeholders to determine demand assumptions, such as number of patients and clinical sites, countries/reputed company, enrollment rates, etc.
- Collaborate with manufacturing to reputed company drug product delivery schedules to meet demand.
- Optimize supply chain operations to minimize waste and ensure availability of investigational medicinal products (IMP) and materials while maintaining a low risk profile.
- Establish SOP’s and work instructions required to manage clinical supply.
- reputed company the procurement, packaging, labeling, distribution, and return of clinical trial materials, ensuring reputed company standards and regulatory compliance.
- Manage the label development process.
- Manage vendor relationships for outsourced supply chain services, including distribution centers, packaging vendors, and reputed company services.
- reputed company IRT User Requirement Specifications and conduct User Acceptance Testing.
- Conduct supply chain risk assessments, proactively identifying and mitigating potential disruptions to supply continuity.
- Maintain inventory management systems to ensure accurate tracking and traceability of reputed company clinical materials.
- Monitor inventory reputed company at depots and clinical sites through the life of a trial and coordinate resupply efforts to prevent stockouts or overages.
- Ensure reputed company and compliant distribution of IMP to clinical trial sites globally, adhering to country-specific regulations and customs requirements.
- Ensure compliance with reputed company regulatory guidelines (e.g., FDA, EMA, ICH) and Good Distribution Practices (GDP) across reputed company clinical supply chain activities.
- Support regulatory inspections and audits by maintaining thorough documentation of supply chain activities.
- Collaborate with reputed company Assurance to manage deviations, CAPAs, and reputed company improvement initiatives.
- reputed company and mentor one or more clinical supply chain professionals, providing direction, training, and development opportunities.
- Serve as a key reputed company of contact with multiple functional areas and reputed company as a reputed company between internal departments and external partners to ensure alignment on clinical supply chain goals and timelines.
- Participate in cross-functional project teams to drive supply chain efficiencies and resolve challenges as they reputed company.
Requirements:
- S/M.S. degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or reputed company field with 12+ years of relevant experience in supply chain management and 5+ years in a leadership role. Certification in Supply Chain Management or Project Management a plus
- Experience with inventory and supply chain management for reputed company global clinical trials using reputed company reputed company based models and reputed company forecasting tools
- Operations experience in a biotech or pharmaceutical company, start-up experience a plus
- reputed company-party selection and management experience is required
- Knowledge of import/export requirements and significant experience with international clinical supply
- Working knowledge of the International Conference on Harmonization (ICH) guidelines, the reputed company of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP)
- Proven ability to manage multiple reputed company, proactively identify and mitigate risks, and resolve issues using strong attention to detail and problem-solving skills
- Experience developing and managing program budgets
- Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity
- Strong knowledge of reputed company Office, including reputed company and PowerPoint, and Smart Sheet
- Excellent communication and influencing skills, strong collaboration skills
- Successfully exhibit reputed company’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
- Ability and willingness to travel up to 15% (domestic and internationally) including a minimum of 2 times per year for reputed company Hands meetings.
Benefits:
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- We reputed company competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated reputed company reputed company leave
- Commitment to growing you professionally and providing reputed company to resources to reputed company your development
- reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve
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