Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
Essential Duties and Responsibilities
- Leads the operational strategy and drives the planning, oversight and execution for clinical trials to achieve program objectives and high-quality deliverables within established timelines and budgets.
- Develops and maintains budgets for the study that include short and long-range clinical forecasting based on clinical activity to support Clinical Development financial goals.
- Assists in the authoring and ensures timely development of core clinical trial documents (e.g., study protocols, investigator brochures, informed consent documents, case report forms, statistical analysis plans, monitoring plans, data management plans, etc.) and Regulatory documents (e.g., IND, NDA or BLA) to ensure the completeness and accuracy.
- Leads contracting/outsourcing process and the development of clinical outsourcing strategies and plans, including identification, evaluation, selection of external CROs (capabilities assessment, project budget, contract negotiations, etc.).
- Forecasts trial resource needs (external costs); accountable for the program level clinical operations budget, management and tracking of trial budget in conjunction with CRO.
- Establishes policies and operational practices to ensure exemplary medical and ethical standards in collaboration with the Medical Director and other platform Heads.
- Drives all study activities at a program level, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports. In conjunction with the CRO, tracks study status, timelines, enrollment, regulatory documentation, and site startup status for clinical trials.
- Directs oversight of internal Clinical Operations staff and external CRO in compliance with GCP and SOPs to ensure operational plans, timelines, and budgets are aligned with corporate objectives and standards, as well as program goals. Drafts the oversight plans and reviews audit reports to oversee the day-to-day performance of CRO.
- Develops the clinical operations strategy including risk management and contingency planning. Provides answers and solutions to abnormal problems in clinical trials.
- Identifies and communicates with therapeutic leaders for feedback on study protocols, development plans, etc.
- Provides operational leadership for IND, NDA and/or BLA filing activities for assigned program when applicable, including, but not limited to: development and oversight of cross-functional database lock activities within timeline; evaluation of clinical data with vendor partners; provide leadership of operations team for inspection preparedness.
- Attends and manages study-specific meetings (e.g., Study Management Meetings, investigator meetings, Regulatory meetings, etc.) as applicable.
- Familiar with the ethical review mechanism at different levels, assists the registration and reporting department to submit new drug registration, and effectively promotes the process of research approval.
- Willingness and ability to travel domestically and internationally, particularly China, as required (up to 25%).
Education and Experience
- Bachelor’s degree in Life Sciences or Pharmacy. Advanced degree is preferred.
- At least 10 years in the pharmaceutical industry and/or CRO, with at least 5 years in a leadership role overseeing the successful execution of clinical trials.
- Demonstrates extensive experience in setup, execution and operational management of domestic and international clinical trials from phase I-III across oncology areas.
- Experience in review or writing of clinical protocols, study manuals, case report forms, and informed consent forms is required.
- Solid well-grounded experience in critically evaluating, negotiating and selecting outsourced CRO.
- Ability to meet project timelines and project budgets across clinical trials.
- Demonstrated success in leading, managing, and providing guidance to clinical operations study teams including CROs, consultants and vendors.
- Demonstrates extensive successful experience in cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing).
- Strong understanding of global regulatory and compliance requirements including but not limited to US CFR, FDA and ICH/GCP.
- Ability to assess complex issues and identify creative, practical solutions.
- Ability to communicate effectively with physicians, fellow employees, patients, guests, contractors.
- Ability to multi-task and work in a fast-paced environment.