Manager, Direct to Site (US) at Myonex in Norristown, PA

Company Description

With offices in the US and UK, Myoderm is a global leader and specialist in sourcing, distribution, and management of comparator drugs and other pharmaceutical products and supplies for clinical trials, including biosimilar trials and research. Our clients span the globe and include the majority of the world's top 10 pharmaceutical companies, as well as biotech companies, CROs, and clinical trial packagers.

OUR CULTURE AND CORE VALUES

Our core values shape and define the culture at Myoderm. We are always looking for bright and motivated individuals who can embody our company values and be a positive addition to our culture:

• Be a Great Team Player
  • We look for employees who are trustworthy and reliable, who help other employees and are concerned with the care for the welfare of all.
• Learn & Grow
  • A common trait shared by Myoderm employees is the desire to take on opportunities to learn new skills or take on new tasks that help both themselves and Myoderm grow.
• Be Customer Focused
  • Our employees always stand accountable with clients, pay attention to detail and continually do the right thing.
• Find a Way
  • Myoderm employees take initiative in order to generate solutions and solve problems in an adaptable, fast-paced environment.

At Myoderm, we are actively seeking candidates who have the ability to stay focused, work productively and produce efficiently in a continuously evolving and complex environment. We are committed to developing our employees through training and opportunities and supporting our community through volunteerism. We work hard while still having fun and supporting each other. If you’re interested in joining our team, the following positions are currently available. We look forward to hearing from you.

Job Description

This position will report to the Senior Director, Global Direct to Site and is responsible for leading and managing the Direct to Site (DTS) team in the US to support the needs of any project that requires services and oversight from the DTS group. As the DTS US Manager, you will have regular communication with clients and will also directly manage a team of Project Managers/Associates.

The position is also responsible for providing clear and concise communication between Operations and Ancillary Supplies, Quality, Procurement, Finance, and Clinical Trial Supply Europe; and helping to foresee problems with products or services before they occur.

A s a member of our Direct to Site Team you’ll be expected to:

• Oversee all activities of the DTS team in the US; oversee DTS PM’s and associates tasks to support accurate procurement, labeling, and distribution activities
• Hire, develop, manage and lead a team of DTS Project Managers/Associates to meet the needs of the company and our clients
• Interact with clients to ensure satisfaction and build long-term relationships
• Create and maintain Key Performance Indicators (KPI’s) for the DTS US department
• Work closely with clients to determine clinical trial requirements and develop appropriate supply strategies, project timelines, and projects plans to meet the client’s study needs
• Generate proposals / budgets which accurately reflect the needs of the clinical project
• Interface with appropriate external customers to successful deliver the client’s product requirements in a timely and cost-effective manner
• Manage the development of departmental procedures and staff training plans
• Create accurate invoices and alert the finance team when appropriate
• Coordinate closely with the client in the pre-project planning phase to define the requirements (documents, drug products, forms and/or labeling, if required). This includes creating protocol specific Label Proofs, Batch Records, Distribution Instructions, Drug Shipment Request templates, and other study documentation.
• Coordinate with internal departments to ensure appropriate drug is procured for the client, ensuring t activities are performed in accordance with client expectations, appropriate industry regulations (EMEA/Home Office/FDA), and industry accepted Quality standards
• Manage both internal and outsourced packaging and labeling activities including project setup, communication of client requirements, sourcing of labels and other packaging supplies as needed, management of material flow, and coordination of batch record review and release
• Support the growth of new services lines at Myoderm in support of clinical trial services
• Participate in GMP labeling and distribution activities, as needed, based on workload and resource availability (Activities will occur in both the ambient and 2-8C environment)
• Collaborate with peers to drive process improvement
• Attend industry events/conferences in support of new business development and enhancing existing client relationships

Qualifications

• Bachelor’s Degree or equivalent experience
• Minimum of 5 years’ experience in the clinical supply field; experience in labeling and/or distribution preferred
• Experience in leading project management teams preferred
• Ability to be flexible, work as part of a team, and manage multiple projects simultaneously
• Ability to adapt to different client needs and to develop and maintain successful working relationships
• Good numerical competence in order to analyze facts and figures
• Ability to make important decisions and cope with the pressure of demanding targets and tight deadlines
• High attention to details
• Analytical skills and problem-solving abilities

Additional Information

All your information will be kept confidential according to EEO guidelines.