Phone: (267) 387-0090
Position Overview
Our client is committed to identifying and advancing transformative therapies for people with cancer and rare diseases with limited treatment options.
Role
The Director/Sr. Director – Clinical Operations is responsible for providing leadership to assigned Clinical Program(s) and for ensuring studies (Phase I-IV) within a program are being managed in accordance with the company’s overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a Clinical Program are in compliance with the company’s procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Sr./Director – Clinical Operations is also responsible for the development and implementation of clinical monitoring standards and best practices for effective clinical monitoring of investigational sites in accordance with regulations for identifying and leading strategic and continuous improvement initiatives in monitoring and clinical project management.
Job Responsibilities
- Provides leadership in the development of the clinical trial management, budget and resourcing strategy at a clinical program level as a Clinical Operations Program Lead.
- Collaborates with the SVP, R&D Operations, to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
- Provides leadership to Clinical Projects to ensure trial/study teams, are managed in alignment with clinical program and company goals.
- Provides Clinical Program updates, including trial status/metrics, budget, accomplishments and risks to SVP, R&D Operations, Program/Portfolio Managers, Senior Management and other relevant stakeholders.
- Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training and other tools to ensure compliance with FDA Regulations.
- Guides and supports trial management activities including, budget management, study management, CRO/vendor oversight, risk mitigation and Good Clinical Practice (GCP) related to the drug development process.
- Provides leadership in the development of monitoring strategy for all clinical trials.
- Oversees and participates in the selection of monitoring resources.
- Responsible for development, implementation, and oversight of novel monitoring approaches.
- Performs or oversees co-monitoring visits to ensure CRA performance is in alignment with the company’s expectations and that monitoring is being conducted in alignment with ICH/GCP guidelines and study-specific monitoring plan.
- Participates in development and maintenance of clinical monitoring SOPs, tools, and document templates (e.g. monitoring plan and monitoring visit report templates).
- Collaborates cross-functionally with Quality Assurance to resolve systematic monitoring and site oversight errors detected in audits.
Job Requirements
- Bachelor's degree in a scientific or health-related field is required.
- Master's degree in a scientific or health-related field is preferred.
- PMP certification preferred.
- Minimum of 10-12 years of clinical research experience, including on site monitoring experience.
- Minimum of eight to ten years of experience in the management of clinical trials as a project manager or other relevant experience at a pharmaceutical/biotech company or CRO.
- Minimum of four to six years of prior supervisory experience required.
- Expert knowledge of GCP's, FDA regulations and ICH guidelines required.
- Strong ability to prioritize tasks and keen attention to detail.
- Excellent writing, communication, and presentation skills.
- Demonstrated leadership and project management skills.
- Proven ability to work on multiple projects in a fast-paced environment.
- Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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