At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
We are looking for a motivated and experienced candidate to lead DICE’s supply chain management function to support forecasting, packaging, labeling, distribution, and sourcing activities of all of our clinical programs. This position will also lead the DICE’s materials and inventory management efforts to ensure uninterrupted supplies for on-time GMP manufacturing of APIs and clinical trial materials.
- Responsible for managing clinical supplies for global clinical trials associated with multiple programs at various stages (Phase 1, 2, 3 and beyond).
- In addition to clinical study support, other responsibilities include protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and oversight of clinical service providers.
- Responsible for maintaining inventory safety stock targets at all global depots.
- Responsible for Drug Supply Manager role in the selected Interactive Response Technology (IRT) for management, maintenance, and oversight. Will help with lot release, set-up and distribution activities. Will support with specification design and UAT design as necessary.
- Create, review, and approve documentation (including batch records) related to packaging, labeling, and distribution of clinical trial materials.
- Provides Logistical Support. Responsible for Distribution and Logistic activities of Drug Substance, Drug Product and Clinical Trial Materials. Candidate must be knowledgeable in import/exports regulations, understanding and providing the required shipping documentation (i.e. invoices, bill of lading, etc.), and coordinating pickup reservations and monitoring logistic partners performances.
- Manage global end-to-end supplies for drug substance raw materials, intermediates, reference standards, drug products, finished drug products, and inventory management.
- Revise and create department SOPs and Work Instructions as needed
- Work collaboratively with Regulatory Affairs to ensure country approvals are aligned with supply management downstream activities.
- Work with QA on timely packaging/labeling batch releases.
- Evaluate and select contract service providers (CSPs) and oversee materials management and clinical supply chain logistics.
- Help the broader CMC teams in budget planning for ongoing and upcoming clinical programs.
- Support other tasks as required by Supply Chain Management such as review inventory reports for accuracy and integrity, track shipments to its destination, review and close out reported temperature excursions, and conduct shipping validation studies as needed.
- Participate in CMC teams and represent the department at CMC and project meetings and work closely with cross-functional teams to meet project timelines and goals.
- Travel to the sites of CSPs to oversee the packaging and labeling activities.
- Keep abreast of latest developments in supply chain logistics, cGMP requirements and regulatory guidance.
Qualifications and Requirements:
- Requires a BS degree (preferably in Supply Chain Management) with a minimum of 8 years of experience in a clinical supply chain management role in biotechnology/pharmaceutical industry.
- Experience managing contract packaging and labeling organizations.
- Experience with managing clinical trial supplies from early to late phases of clinical studies; including blinded studies.
- Manage supplier oversight activities and supplier performance.
- Good interpersonal skills, able to collaborate effectively with cross-functional teams and external partners.
- Excellent project management and communication skills.
- Demonstrate knowledge of clinical trials, drug development, and regulatory guidance (e.g. cGMP, GDP, GCP, ICH requirements).
- Ability to deliver under tight timelines and adapt to changing project needs.
- Ability to work on multiple projects at the same time.
- Ability to communicate, organize, and write well.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.