We are seeking a highly motivated individual to join Turning Point Therapeutics as a Clinical Trial Supplies Specialist reporting into the Director of Clinical Trial Supplies. The Clinical Trial Supplies Specialist has operational end-to-end responsibility for assigned study activities. As a key member of the Clinical Trial Supplies team, the successful candidate will work closely with the Director of Clinical Trial Supplies to define and execute an optimal clinical trial supply strategy for all Turning Point Therapeutics’ clinical trials, including effective risk management to ensure supply continuity to patients.
This position also provides an opportunity to join a growing organization and contribute substantially to how the company will execute supply chain activities in the future. In addition, there is an opportunity to expand your knowledge through day-to-day activities and close interactions with Clinical Operations, CMC, Data Management, Regulatory, and Quality Assurance teams within Turning Point Therapeutics.
- Reviews clinical trial protocols/protocol amendments and provides inputs to develop optimal packaging design, clinical trial supply design, and distribution strategies.
- Oversee clinical trial supplies processes, including packaging, logistics, distribution, and third-party warehousing.
- Assists in the finalization of packaging designs and labels that comply with global regulatory agencies for investigational new drugs.
- Manages batch record review and batch release of labeling activities.
- Participates in the selection, evaluation, and approval of third-party contractors for packaging, labeling and distribution activities.
- Collaborates with study teams and vendors to ensure proper distribution of clinical trial supplies to sites.
- Supports day-to-day IxRS/IRT operational activities related to drug supply management.
- Contributes to Pharmacy Manuals and supply related training/instructional materials.
- Triggers and tracks shipments of Investigational Medicinal Products (IMPs) globally.
- Identifies, assesses, and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.
- Proactively communicates key issues in a timely manner to the appropriate management level and to/or any other relevant project team members.
- Monitors and reports Key Performance Indicators (KPI) for clinical trials supplies management to enable strategic objectives to be met or corrective action to be taken.
- Participates in quality event investigations related to labeling, storage, and distribution.
- Supports reconciliation and accountability of clinical trial supplies.
- Participates in the development, review and implementation of departmental SOPs and processes.
- BA/BS degree in Science, Business, Engineering, Supply Chain, or equivalent.
- APICS CPIM, CSCP or related certifications a plus.
- 2-3 years of experience in clinical trial supplies.
- Working knowledge of cGMP/GCP regulations related to clinical labeling, packaging and distribution.
- Experience with IxRS/IRT system design, implementation, and user testing.
- Excellent written and verbal communication skills.
- Experience in inventory management systems or ERP systems a plus.
EEO & Employment Eligibility
Turning Point Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Turning Point Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Turning Point Therapeutics is an E-Verify employer.
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