The Associate Director, Clinical Supplies provides technical and operational support for PTC's clinical trials by managing drug supply with an emphasis on secondary planning, packaging, labeling, distribution and return activities. This includes, but is not limited to: interpreting clinical protocols into packaging requirements and designing the packaging, labeling and subsequent assembly of Clinical Trial Materials (CTM).
The incumbent presents CTM-related information to PTC's clinical organization and study Contract Research Organizations (CROs) to prepare investigator site accountability logs, dispensing logs, patient take-home instructions, return/destruction forms and study reference manuals. He/she is also the primary contact for receiving and documenting product complaints and incidents from Clinical Development. The incumbent works closely with Regulatory Affairs to draft label text for secondary packaging and obtain the appropriate approvals and translations to meet local regulatory requirements. He/she also manages other regulatory documentation as required.
The Associate Director, Clinical Supplies manages direct report(s).
The incumbent works cross-functionally with internal departments and external resources on Clinical Supply related issues.
The Associate Director, Clinical Supplies supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
- Forecasts the short- and long-term CTM requirements necessary to support multiple global clinical trials.
- Defines the secondary packaging and labeling design in accordance with product stability and storage parameters, clinical study dosing and dispensing criteria and local regulatory requirements.
- Develops timelines and schedules for production release and distribution of clinical trial material.
- Forecasts, budgets, manufactures, packages and labels CTM; develops timelines schedules for the release and distribution of CTMs.
- Prepares purchase requisition information for associated services and assists in preparing, maintaining and managing the annual clinical supplies budget.
- Assures Good Clinical Practice (GCP) compliance by reviewing and writing relevant sections of clinical protocols, study reference manuals, clinical site accountability logs, dispensing logs, patient take-home instructions and CTM return/destruction forms.
- Presents CTM-related information at investigator meetings.
- Receives and documents product complaints and incidents from investigator sites.
- Defines, tests and approves Interactive Voice Response/Interactive Web Response (IVR/IWR), system specifications and user requirements for tracking inventory, allocation, distribution, use date management, destruction activities, reports and alerts.
- Coordinates Quality Assurance (QA) activities related to packaging, labeling, inventory and distribution ensuring adherence to GMP (Good Manufacturing Practice), GCP and ICH guidelines by creating and maintaining SOPs and other procedural documentation.
- Identifies vendors/resources necessary to ensure the successful execution of clinical supply plans by creating Requests for Proposals (RFPs) and participates in the negotiation and processing of the legal documents required to engage the vendors services; partners with QA department on matters related to CTM supply management.
- Manages the daily inventory, distribution, return and destruction activities including IVR reports, notifications, expiry dating, shipment requests, receipts, temperature recordings, returns and reconciliations.
- Manages, coaches and mentors direct reports.
- Performs other tasks and assignments as needed and requested by management.
* Minimum level of education and years of relevant work experience.
- Bachelor's degree in a pharmacy or scientific discipline and a minimum of 7 years of progressively responsible CTM management experience in a pharmaceutical, biotechnology, CRO, university medical center or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
- Hands-on experience supporting and understanding GMP, GCP, and International Conference on Harmonisation (ICH) guidelines as related to CTM labeling, packaging and distribution operations and the overall drug development process.
- Hands-on experience supporting multiple international trials.
- Experience developing and using vendor IVR/IWR tools.
- Demonstrated people and project management experience.
- Ability to influence without direct authority
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
- Experience using MRP or ERP systems such as SAP or Oracle
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
Bread Financial | , New Jersey
Cox Automotive Mobility | Windsor, New Jersey
Sonepar USA | Cranbury, New Jersey
Sonepar USA | Ocean Township, New Jersey
Walgreens | Middletown, New Jersey
Walgreens | Toms River, New Jersey
Walgreens | Neptune City, New Jersey