What We Look For
We are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are relentless in our focus to offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face. We are building an exciting and fast paced company passionate about discovering and developing tomorrow's most innovative cancer therapies.
We are seeking an Associate Director of Supply Chain to lead the supply chain for novel clinical programs. The Associate Director of Supply Chain will be accountable for building the clinical supply and demand planning processes, managing clinical orders and providing oversight for logistics providers throughout the development stages of antibody-based radiopharmaceuticals. This role will be the main liaison between Tech Ops, Clinical Operations, CROs, CMOs and clinical sites for ongoing and new clinical studies.
Principal Responsibilities
Lead and manage clinical demand and supply plans
- Lead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
- Partner with Clinical Operations for evaluation and selection of CRO partners and IRT vendors. Collaborate regarding CRO capabilities to support study execution of study supply, including global depot networks and IRT functionality, as necessary
- Establish and maintain clinical demand plan by chairing a monthly rolling forecast process. Aligning supply plans and orders with the rolling forecast
- Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan
- Collaborate with cross-functional teams (i.e. Clinical Operations, QA, CMC, and Regulatory) to proactively identify and mitigate potential risks to the continued advancement of the clinical programs
Manage clinical orders, inventory of drug substance and starting materials
- Single point of contact for manufacturing sites
- Oversee and coordinate clinical order management process to ensure clinical sites received the drugs on time per plan
- Serve as internal lead for triaging of product issues, temperature excursions, and deviations originating from and clinical sites. Partner with Quality Assurance to resolve any quality-related items. Serve as a subject matter expert and develop continuous improvement plans for clinical supply GMP, GDP, and business processes
- Maintain inventory to ensure it's up to date
- Update expiry with stability data
- Support ongoing drug accountability and end of study drug inventory reconciliation
- Trigger production with reorder point
Accountable for vendor management process and logistics process
- Lead vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distribution
- Manage contract, budget and performance of logistic providers.
- Mange the import and export process
- Align materials lead-time with clinical order supply plan
Business Process
- Establish supply chain business processes as needed
- Create SOPs and work instructions to govern cGMP activities
- Support budgetary requests for supply chain and logistic costs
Qualifications, Education & Experience
- B.S. or M.S. in scientific fields with 8+ years of experience in clinical supply chain and logistics in the biotechnology environment
- Demonstrated in-depth experience of establishing, refining, and operating clinical supply chain in the biotechnology industry
- APICS certification preferred
- Expertise in Lean is desirable
- Working knowledge of import and export laws and processes
- Experience working effectively with CMOs and CROs
Skills & Abilities
- A solid understanding of GMPs and CMC requirements is expected
- Demonstrated thought leadership in clinical supply chain
- Experience in preparing regulatory filings
- Capable of working on multiple projects/tasks and able to meet timelines
- Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment Excellent verbal and written communication skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- A solid understanding of GMPs and CMC requirements is expected
- Demonstrated thought leadership in clinical supply chain
- Experience in preparing regulatory filings
- Capable of working on multiple projects/tasks and able to meet timelines
- Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment Excellent verbal and written communication skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- Ability to critically evaluate and troubleshoot complex problems and attention to detail
