POSITION OBJECTIVE: The Senior Manager, Clinical Supply will be responsible for end-to-end drug supply planning activities across the Athenex clinical portfolio and for leading the clinical drug supply team. Responsibilities include forecasting supply requirements across the clinical portfolio and managing IP (Investigational Product) production and distribution process on time, with good quality, in compliance with Health Authority regulations/guidelines and Athenex SOPs. Collaborates and interacts with key stakeholders within Clinical Operations, Manufacturing Sciences, and Supply Chain, as well as the Quality and Regulatory CMC teams.
Would consider a remote employee but it is preferred this position is located in the Buffalo, NY office.
Essential Job Functions/Responsibilities
• Oversees end-to-end clinical supply planning to ensure adequate supply levels and coordination of timely supply distribution. This includes demand forecasting, production planning (DS, DP & FG), and product distribution to depots and sites
• Partners with Clinical Operations to identify demand assumptions and create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and programs
• Monitors inventory levels through the life of a trial; take preventative actions to avoid potential supply issues
• Ensures changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered
• Reviews clinical trial protocols and understands impact to supply
• Acts as the key liaison between Clinical Operations, Regulatory CMC, Supply Chain, Quality and Manufacturing Sciences
• Works with Clinical Operations, Manufacturing Sciences, and Supply Chain on master production schedule so timing of clinical trial drug needs are met
• Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with relevant departments
• Ensures the clinical drug supply team is working cross-functionally to meet company clinical supply goals
• Modifies operational methods and procedures to streamline processes
• Reviews and updates SOPs and identify the need to assist in establishing new procedures
• Develops and maintains a Clinical Supply Chain Dashboard
Required Education & Qualifications
- BA/BS degree is required. Advanced degree (M.S. or Pharm.D.) in scientific or related pharmaceutical field preferred.
- 8 years of progressively responsible pharmaceutical industry experience with a minimum of 3 years clinical drug supply. Line management experience preferred.
- Proven ability to successfully operate a clinical supply chain partly based on outsourced capabilities is critical
- Experience managing and leading a team
- Ability to build, convincingly communicate and execute strategic and operational plans for a global clinical supply chain function.
- Experience with global clinical trials preferred
- Strong ability to collaborate and build strategic relationships with internal (clinical operations, quality, etc.) as well as external (CMO, CRO, etc.) stakeholders.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
- Knowledge of cGMPs and relevant FDA and EU Regulations
- Familiarity with US and EU regulatory agencies and their guidance
- Ability to multi-task and shift priorities appropriately in a dynamic, fast paced work environment
- Strong analytical and organizational skills – Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions.