Associate Distribution Manager /Distribution Manager, Global Distribution Clinical Supplies – MedImmune – Gaithersburg, MD, USA
his position can be filled at either the Associate Distribution Manager or Distribution Manager position depending upon experience.
* Manage and deliver Drug Substance (DS), Drug Product (DP), and Investigational Product (IP) distribution & returns activities for Logistics and Clinical Supply (LCS)
* Work collaboratively within LCS, with external vendors, and with all other interfaces and stakeholders as required to enable highly effective delivery of Distribution Management responsibilities
* Liaise with interfaces and stakeholders internally and externally as required in development of import/export intelligence. Ensure effective application of current intelligence in development and delivery of practical distribution strategies for assigned clinical studies
* Contribute to the operational effectiveness of LCS
* Manage and deliver DS, DP and IP distribution and reconciliation activities and enable development and implementation of practical distribution strategies for all assigned Development Projects both domestic and international
o Deliver distribution recommendations for DS, DP, Investigational Medicinal Products (IMPs) and Non-Investigational Medicinal Products (NIMPs). Includes all depot to depot shipments and all shipments to clinical sites across assigned clinical studies.
o Select and provide strong oversight to distribution vendors in conjunction with key stakeholders and develop lead times for activities undertaken
o Provide clear and up-to-date communications to external vendors in relation to distribution needs of assigned projects
o Ensure that distribution management information related to assigned projects is appropriately delivered and maintained
o Facilitate / drive production of all necessary documentation, licenses and permits in relation to assigned clinical projects
o Maintain oversight of the IP returns process (including stock recovery) to aid in documenting full IP reconciliation
* Collaborate effectively within LCS to enable successful on-time delivery of quality DS, DP, IMP and NIMPs to assigned projects.
* Maintain & expand close cross-functional relationships internally and externally, in order to best effect provision of appropriate systems (e.g. support to IXRS User Acceptance Testing), and distribution of clinical supply materials for assigned projects
* Liaise closely with Quality Assurance (QA) to coordinate activities such as shipper qualification, cold-chain demonstration and all activities expected in accordance with cGMP, GDP, GCP, & ICH guidelines
* Partner with stakeholder departments to ensure that any issues relating to DS, DP or IP distribution (such as complaints, excursions, or deviations received from sites or shipping vendors) are highlighted and options/recommendation are developed quickly for risk mitigated study supply and cross-project learning
* For assigned projects champion and represent distribution activities in project meetings as required, and otherwise support the LCS Study Manager by contribution to overall supply planning, distribution strategy and effective use of distribution systems for stakeholder reporting etc.
* Create, or assist in the creation of departmental SOPs, processes and systems to support improvement and future growth of Distribution best practice.
* Apply skills and knowledge to develop LCS clinical supply import/export intelligence, enabling efficient data capture and retrieval for enhanced cross project learnings
* Collaborate in the creation and maintenance of a territory ‘manual’, including project learning’s and experience as relates to IP distribution across international borders
* Attend and actively participate in departmental meetings
* Participate where required in LCS departmental and/or assigned cross-functional process improvement initiatives
* Apply own unique training and expertise to effectively fill and deliver against flexible assignments within other aligned LCS roles as required
* Mentor, develop and supervise other members of LCS assigned to flexible roles within the Distribution team
* Communicate effectively with assigned teams, BPD, and with all interfacing functions and relevant groups as required
Associate Distribution Manager
Bachelors of Science Degree with 5-8 years of experience
Masters of Science Degree with 3-6 years of experience
Bachelors of Science Degree with 10-14 years of experience
Masters of Science Degree with 8-12 years of experience
NOTE: Degree should be in basic or applied science or engineering.
*The Associate Distribution Manager/ Distribution Manager will have appropriate direct experience working in a development or technical operations environment in the pharmaceutical, scientific or health care product industry.
* Specific experience in IP management and supply is highly desirable.
* Some experience of IP distribution and a good understanding of cGMP, GCP and ICH guidelines as relates to IP management is required.
* An understanding of imports/exports regulations and global distribution regulations and dangerous goods regulations in distributing all medicinal supplies. Specific experience may include investigational products, non-investigational products, devices and instruments used in the medical field.
* Experience in the Biotechnology and/or Pharmaceutical industry is required and some prior experience in IP management and supply is highly desirable
* Preferably will have a sound understanding of the drug development process and ideally also demonstrable success in delivery of cross-functional projects and/or activities
* Ability to work in a dynamic environment, and to collaborate effectively within cross functional teams to deliver complex projects
This position requires a high level of commitment, flexibility, initiative and an ability to work with minimal direct supervision. The Associate Distribution Manager/ Distribution Manager must be a highly organized individual who possesses excellent attention to detail, and demonstrates strong skills for planning, coordination, teamwork and communication. Proficiency in Microsoft Outlook, Word, Excel and PowerPoint is expected.
This is a complex and interactive job requiring excellent communication skills, combined with the ability to troubleshoot a range of problems, and to recognize where it is necessary to draw in additional expertise. The position requires an individual who can achieve results through both formal and informal networks and who can effectively multi-task across activities of varying priority. The Associate Distribution Manager/ Distribution Manager must have the ability to recognize activities or events that may critically affect study supply and act on or relay that information to the appropriate party. This individual will be a highly effective representative for Distribution Management as the primary technical contact on assigned projects. This position requires an individual who has the emergent management skills appropriate to be an effective mentor and has the ability to coach and train in relation to Distribution activities where required.