Clinical Pharmacology Operations Lead
* The incumbant will provide operational oversight and delivery of Phase 0, Phase I and applicable Phase IV studies that may or may not be part of a development program.
* In situations of a NCE with anticipated need of support from Clinical Pharmacology Operations, the Clinical Pharmacology Lead will manage and oversee the program in conjunction with the Global Clinical Operations
Lead until the Proof of Concept is achieved.
* Post Proof of Concept, the Clinical Pharmacology Operations Lead supports the Global Clinical Operations Lead by overseeing the delivery of Clinical Pharmacology studies.
30% -45% From Nomination for Development to Proof of Concept:
o Provide functional input in to the early development plan.
o This collaboration may include but is not limited to the physician, pharmacokineticist, statistician and relevant functional areas on clinical trial designs;
o Provides strategic clinical programs input to GDT.
o Provides reports on programs/studies overseeing, related activities and milestones.
* May attend advisory panel meetings and regulatory agency meetings related to strategy of program, indication, or studies;
* Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, promotional guidelines and labeling) to drive the clinical trial application process;
* Effectively represent the interests and perspectives of GCDO; presents program/study(ies) overviews/status to senior management, cross-functional team, and external partners as necessary.
30% - 45% Oversees or is responsible for the Phase 0, I and applicable IV studies which comprise either a program or study. Which includes, but is not limited to:
o the production of study related documents such as, but not limited to synopses/protocols and Informed Consent Documents.
o responding to issues raised in audits (R&D QA or Compliance)
* Collaborates with external stakeholders and/or internal functions to ensure successful implementation of program / study.
* As applicable, participates or leads in the selection of vendors including the review of contracts, change orders, and work order in collaboration with Procurement and Vendor Management.
* Supports integrated project goals, contributes to budget (forecasting and accrual management) and timeline development, and provides updates to management on study progress and outcome.
* Attends and/or presents at relevant internal and external meetings; conducts study level training; aligns program or cross-functional team regarding execution, and reporting of program / study milestones including risk mitigation.
* Authors, contributes, and/or reviews regulatory and submission documents, including investigator brochures, IND, and annual reports, NDA, publications and product label updates.
* To oversee the study (both from 'in-house' and at the Investigative Site) and monitor source data against data management systems.
* May be asked to contribute/deliver tasks that are consistent with the position, but not listed in this job description
5%-20% Manages capacity and ensures staff with appropriate skills, knowledge, training, and experience are assigned to study activities:
* Ensures proper metrics and diagnostics are utilized for effective resource management and allocation.
* May be involved in interviewing, hiring, training and retaining employees
* Provide direct feed back to the study or project reports as necessary
* May assess long-range study or project resourcing needs and make recommendations and allocations across program(s)
5%-20% Reviews and contributes to strategy for operational efficiency and SOP development:
* Works closely with the applicable finance business partner and/or study team(s) to generate, report and discuss the financial aspects (i.e., budgets, long range plans, monthly accruals) of Phase 0, I and applicable IV studies.
* Provides functional advice to the due diligence team in the evaluation of business development and licensing activities.
* May participate in process improvement exercises.