The Therapeutic Area Manager is responsible for ensuring that robust supply plans within designated therapeutic area(s) are in place to meet the needs of Clinical Supply Optimization and Clinical Ancillary Management service portfolios putting the right structures in place to optimize global and regional supply strategies with regard to efficiency, cost effectiveness, and continuity of patient supply.
It also implements demand and operations planning processes to minimize supply chain waste and maximize operational capacity in partnership with Demand Planning and Supply Chain Strategy Teams.
What you will do
Ensures consistent, clear clinical supply contracts are negotiated with clinical customers to ensure supply is fit for purpose and meets the needs of study and patient
Manages staff and simplifies supply at program level, where practical, to reduce cost and increase flexibility of supply for Phase I-IV clinical studies conducted globally
Ensures effective resolution of challenges and issues that have the potential to impact patients, study progression or data quality
Ensures effective management of quality within team and quality investigations, customer complaints and associated CAPA’s are completed in a timely manner.
Liaises with Global Supply Chain Management Leadership to ensure global process alignment, SOP creation and maintenance, and training for the team.
Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to develop new or improve existing processes and ensures compliance and appropriate documentation of processes and procedures.
Stays abreast of relevant cGMPs, GCPs, and other regulatory requirements and ensures study management activities are aligned.
Manages, tracks and monitors business budgets, including personnel costs and headcount planning, as well as, client invoicing.
Develops and monitors appropriate metrics and proactively makes adjustments to ensure business success.
Engages and participates in divisional initiatives that are related to or involve Clinical Supply Optimization and / or Clinical Ancillary Management.
Achieves optimal results by effectively partnering with subject matter experts across multiple functional areas
Represents and appropriately positions the services for potential clients
Demonstrates the ability to promote the company vision
How you will get here
Bachelor’s Degree in operations management or science related field (equivalent experience may be considered). Prefer advanced degree in a health related or business field.
5+ years of experience leading diverse, direct and matrixed teams; in both co-located and remote situations.
Minimum of 7 years of pharmaceutical experience;
Financial management and people management skills are critical to this position.
Domestic and international travel will be at 25-40%
Experience in clinical manufacturing and packaging is preferred
Excellent project and process management skills gained within a complex matrix organization.
Ability to lead matrix and cross-functional teams.
Strong leadership, communication and interface management skills, combined with the ability to lead and influence others and achieve positive outcomes.
Demonstrated leadership in establishing goals and meeting business objectives