TP Therapeutics is seeking a Clinical Trials Supplies Manager (CTSM) with strong clinical trial supply management experience who will report directly to the VP of Clinical Operations. The mission of TP Therapeutic’s CTSM is to define and execute an optimal clinical trial supply strategy for all TP Therapeutic’s clinical trials including effective risk management to ensure supply continuity to patients. The CTSM has operational end to end responsibility for assigned study activities and leads and manages all clinical trials supplies vendors and systems.
- Represents clinical trial supplies as a core member of the Clinical Trial Team (CTT); defines and advises the CTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management.
- Reviews all clinical trial protocols/protocol amendments and provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule (key study parameters and milestones, patient screening and enrollment projections, with appropriate overage).
- Creates and drives finalization of the packaging design and generates labels that comply with global regulatory agencies for investigational new drugs.
- Provides interpretation of regulatory guidance documents, regulations and directives and advice regarding their applicability and impact on internal labeling runs.
- 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.
- Manages internal and third-party deviations, customer complaints, and change controls to support cGMP labeling and distribution activities.
- Designs, configures, and reviews IWRS/IVRS system(s) for drug supply management, accountability, and enrollment of global clinical studies. Initiates subsequent updates throughout the duration of the clinical trial.
- Triggers and tracks shipments of Investigational Medicinal Products (IMPs) from central depot(s) to regional hubs and local depots, globally.
- Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
- Develops and executes a clinical supplies trial-level project plan (timeline) together with all other relevant functional areas.
- Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.
- Collaborates with all relevant functional departments for country submission and approval timelines (including IND/IMPD amendment) to develop optimal supply strategy.
- Is responsible to work with Clinical Operations Study Lead on the management of the clinical trial supply budget(s) (e.g. labels, packaging, distribution and comparators).
- Proactively communicates key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant project team members.
- Provides guidance and technical training as Subject Matter Expert or recognized technical expert.
- Ensures/develops adequate documentation, processes and systems are available and followed for labeling, distribution, returns, reconciliation and destruction of clinical trial materials activities (SOPs / Protocols review /approval).
- Supports product development and QA in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to labeling and distribution practices.
- 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.
- Minimum BS in scientific discipline.
- Experience in managing clinical trial material packaging, labeling and logistics required.
- Minimum 5 years of experience in the pharma/biotech industry.
- Ability to effectively organize and prioritize tasks to achieve established deadlines.
- Strong verbal and written communication skills.
- Good presentation skills.
- Ability to work effectively in cross functional environment.
- Strong knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory requirements (e.g., US, Asia, Europe and Latin America) and an ability to interpret current regulations and requirements in the labeling context is essential.
EEO & Employment Eligibility
- TP 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. TP 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. TP Therapeutics is an E-Verify employer.
To apply, please submit your resume to email@example.com