Principal Project Manager, Clinical Supply

Benefits

Qualifications

• •Must have experience in one of the following areas:
• •Drug Discovery (e.g. Process Chemistry, Analytical Chemistry), Drug Development (e.g. formulation), Clinical Operations (e.g. Clinical Project Management), Supply Chain (e.g. Clinical Supplies Project Management), or Quality Assurance
• •High degree of flexibility and a strong aptitude for identifying innovative approaches in decision‑making and problem solving
• •Must be able to proactively and effectively recognize, quantify and mitigate potential risks
• •Proven leadership skills in the management of complex projects
• •High degree of flexibility and a strong aptitude for identifying innovative approaches in decision‑making and problem solving
• •Must be able to proactively and effectively recognize, quantify and mitigate potential risks
• •Ability to think in multiple dimensions and balance many priorities to ensure that supplies are delivered within optimal timing, on budget and are of the highest quality while ensuring adherence to applicable regulatory requirements
• •Effective communication skills
• •Extensive knowledge of the clinical supply industry and global clinical trial requirements
• •7 more items(s)

Responsibilities

• •Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1‑IV clinical trials with highly complex study designs and the management of studies with partner companies
• •Expected to work independently with very minimal oversight and supervision
• •Forecasts, plans, schedules, coordinate and executes, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots
• •Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources
• •Translates clinical study design into packaging design
• •Authors the study medication and labeling section of the clinical protocol
• •Develops protocol specific labeling compliant with applicable global regulations
• •Identifies, develops, communicates and tracks project timelines, activities, logistics and milestones
• •Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IRT vendors, quality assurance, clinical team partners, etc
• •to ensure timely availability of clinical supplies
• •Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning
• •Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages
• •Must be SME in some aspect of clinical supply project management activities e.g
• •ADME, EDP, Customs expert who routinely expands and shares knowledge with global group
• •Successfully leads and participates in within function and cross functional process improvement initiatives
• •Leads in troubleshooting and resolving clinical supply related issues ensuring that project needs and priorities are understood by team members
• •Coaches and mentors staff members on clinical supply requirements and topics
• •Provides input and recommendation to DSMs on project timing and resource requirements
• •15 more items(s)