- This position is responsible for operational strategy, planning, implementation and management of our Immuno-Oncology clinical programs including company sponsored, Investigator-Sponsored Trials (ISTs) and Cooperative Group partnered trials. This includes overseeing the activities of all clinical trials from study design through close out including interpretation of clinical programs and the data collection activities; establishing and managing relationships with investigators, key opinion leaders, cooperative groups, vendors and stakeholders (CROs, central labs, IRBs, consultants) to facilitate clinical programs and ensure timelines and deliverables are met and that the studies are conducted in accordance with appropriate regulatory requirements. This role oversees the activities of all clinical trial partners including ISTs and proactively identifies, manages and communicates risks to key stakeholders, peers and senior management.
- Leads the operational strategy and tactics to develop, execute and deliver clinical studies/programs with a focus on speed, cost and quality.
- Establishes and maintains relationships with key opinion leaders and investigator sites and consultants
- Leads efforts for the selection and overnight of external service providers, including CRO and other vendors as necessary.
- Independently manages the clinical study within the timelines and budget.
- Identifies and manages ways to settle study issues that will impact budget, resources and timelines.
- Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment and data consistency.
- Ensures documentation prepared by CRO is completed in accordance with GCP regulatory requirements and consistent with the protocol of the clinical program.
- Contributes to the creation and review of clinical components of key documents (e.g. investigator’s brochures, pharmacy brochures, clinical monitoring plans, Clinical Study Reports, DSUR, ) as needed.
- Provides operational leadership for IND, NDA and/or BLA filing activities for assigned program(s) when applicable, including but not limited to: development and oversight cross-functional database lock activities within timeline; evaluation and if needed, escalation of resource needs both internally and externally with vendor partners.
- Endure Trial Master File is accurate and up to date for inspection preparedness.
- Lead and/or participate in process development and process improvement initiatives including development and authorship of SOP related to clinical trial conduct.
- Must have strong project and people leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
- Excellent oral and written communications with ability to present data to all levels of audiences.
- Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Strong capability of strategic thinking and ability to propose innovative solutions to issues.
- Advanced competence in collaboration & teamwork, communications, influence, strategic agility, planning & organizing, driving results and problem solving.
- Minimum of 8 years of experience in clinical research working in a pharmaceutical, biotechnology or related environment.
- Multi-study experience tuning Phase I, II or III clinical trials in Oncology
- Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
- Working knowledge of Good Clinical Practice (GCP) and Pharma Guidelines
- PhD preferred (Immunology or Oncology)
please email CV and cover letter to firstname.lastname@example.org