Senior Director, Supply Chain
Rain Therapeutics is committed to building a passionate entrepreneurial team of core business leaders to execute on our vision to identify, and execute on the development, of novel therapeutic avenues for the treatment of cancer.
The Senior Director, Supply Chain will lead the supply and distribution of drug substance and drug product for Rain’s on-going clinical trials through the oversight management of multiple Contract Manufacturing Organizations (CMOs) and distribution providers. This position will provide leadership and direction on a cross functional basis to ensure that all clinical trials have timely and adequate supply for administration to subjects. The Sr. Director role will be overseeing demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, sourcing and supply of comparators, and return or destruction of materials.
This position will lead validation of packaging processes for new products and technical transfers, qualify packaging solutions for multiple transport modalities. Additionally, this leader implements and ensures group compliance to procedures for the production and distribution of investigation product. The Sr. Director will provide input and oversight to ensure all tactical operations meet or exceed cGMP regulations, ensuring high level of quality of our clinical supply chain processes. This position will report to the Senior Vice President, Technical Operations.
- Bachelor's Degree (Business, Logistics or Supply Chain preferred) with 15+ years relevant work experience or
- Master’s Degree with 13 year’s relevant work experience within the life sciences industry
- Minimum 10-12 years biotech or pharmaceutical industry experience in clinical operations or supply chain management including 8 years of experience in clinical supply planning, inventory planning & packaging/labeling.
- Experience with product commercialization, packaging design/development, product launch
- Ability to work cross-functionally in a small and fast-paced organization, wearing multiple hats
Critical Job Skills:
- Maintain oversight of supply and shipments and generate weekly reports/metrics to ensure supply needs are being met to support clinical operations.
- Own and/or assess Supply Chain plans and inventories used to support clinical supplies
- Maintain inventory oversight and support the forecasting processes
- Compile weekly dashboards and slides centered around CMC-related operations supporting clinical supply activities
- Develop and analyze full spectrum metrics to drive efficiency and improvements
- Submit accurate and timely administrative reports, attend meetings, work to resolve any clinically centric Supply Chain related issues within a timely manner
- Collaborate with cross-functional teams (i.e. Quality, Supply Chain, Artwork, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities
Preferred Skills and Experience:
- Strong working knowledge of the drug development process (Phase I-III), cGMPs, and CMC functions
- Experience with clinical labeling, packaging and distribution including cold chain, importing and exporting
- Expertise working with DRP, MRP, ERP, systems
- Setup and maintenance of hosted clinical IRT and DIMS systems
- Strong project management skills to manage cross-functional teams and drive consensus
- Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization
- Strong analytical and problem-solving skills
- Able to handle multiple responsibilities and priorities simultaneously under constrained timelines
- Detail-oriented with strong business data analytical skills including Meddata and RTSM
- Process oriented mindset with willingness to call out gaps and seek solutions
- Previous experience leading Supply Chain teams with direct and/or indirect reporting responsibilities