Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early – to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Please visit www.Candeltx.com for additional information.
The Associate Director/Director of Supply Chain is responsible for clinical supply and planning for future commercial supply for 2 lead viral IO products as well as additional marketed products used in combination for multiple cancer indications in Phase 1-3. You will work closely with Clinical, Manufacturing, Quality and Regulatory Operations, supply sites and other functional groups. You will be involved in cold chain logistics for the products. You will also be involved in managing labeling and packaging as well as kits for patient sample management. You will work closely with Clinical Operations to monitor and review enrollment plans and actuals for use in developing the supply requirements plans. This role leads the development and monitoring of supply plans to support business objectives, and provides feedback to clinical project teams, and manufacturing. This position also serves as a key customer liaison and problem solver with multiple internal functional areas and with external organizations. This is an exciting position for someone who is hands on and who wants to build the Supply Chain function at Candel.
The Associate Director/Director of Supply Chain will lead material supply activities for clinical trials, inventory planning, logistics and distribution. This includes integration of complex programs that may require multinational interactions as well as creating strategic plans for development programs. Team leadership and project management are essential functions of the role.
Essential Areas of Responsibility:
- Develop overall supply network and sourcing strategies
- Direct implementation and execution of the supply strategy
- Identify continuous improvement projects to improve supply and supply chain performance to maximize supply efficiency, minimize waste while identifying risks and developing risk mitigation plans
- Direct the creation, monitoring and updating of clinical supply plans based on forecasts from Clinical Operations
- Partner with clinical and regulatory operations to capture critical demand and supply assumptions for planning, such as enrollment rates, number of sites, agency approval dates, etc.
- Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
- Review current databases and make recommendations for improvement
- Create and modify SOP’s
- Lead and coordinate shipping and distribution activities
- Assure achievement of business and operational objectives by contributing information and recommendations to strategic plans and budget reviews
- Develop, maintain, and leverage strong collaboration with internal and external stakeholders to ensure internal and external customer satisfaction
Minimum Education, Experience and Skill Requirements:
- Bachelors in life sciences or equivalent
- Minimum 10 years related experience in the life sciences industry, including Clinical supply management, Project/Program Management, Pharmaceutical Development, and/or Clinical Trials Coordination
- Experience in small growing companies is preferred
- Experience with clinical and/or commercial supplies and supply chain required
- Experience and knowledge of regulations related to labeling and packaging clinical supplies required
- Proficient knowledge of Microsoft Suite of programs required
- Familiarity with clinical trial processes
- Knowledge of trade compliance as it applies to the pharmaceutical industry, including import licenses and customs operations
- Demonstrated experience in inventory management, demand forecasting and supply planning
- Experience with relevant solutions for managing the forecasting, planning and inventory management for drug supply needs
- Familiarity with cGxP operations
- Flexibility and willingness to adapt to external environment influences by developing and adopting new strategies and tactics
- Excellent communication and influencing skills, strong collaboration skills
- Strong attention to detail
- Ability to multi-task and manage complexity