Title: Director Clinical Operations
Reports: Vice President Clinical Operations
Therapeutic Area: Oncology
Location: Morristown NJ – Hybrid Work Requirements
Our biopharmaceutical client located in Northern NJ area has tasked Scientific Search with finding a Director of Clinical Operations. In close collaboration with the VP Clinical Operations, the Director of Clinical Operations will be spearheading all operational aspects of clinical trial activities.
Their world class leadership team is comprised of industry veterans from top biotech companies who have proven track records of bringing novel cancer therapies to market. A science-first mindset and patient-centric approach is their genes.
- Provide strategic direction for clinical operations activities to address key challenges of execution of the Clinical Ops program with innovative and lean solutions.
- Provide direct oversight and management of clinical operation activities in-house and outsourced to clinical research organizations (CROs) including people management in a growing in-house organization.
- Work collaboratively across company functions to:
- Develop clinical timelines and budget forecasts and be accountable for tracking and delivering accordingly.
- Ensure that clinical trials are properly resourced, managed, and executed in accordance with timelines and industry standards (e.g. GCP, GLP, ICH guidance).
- Organize study related meetings within/between departments as needed.
- Lead initiatives to build clinical department infrastructure.
- Lead multiple clinical studies with varied research focus.
- Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline with an advanced degree preferred.
- At least 5 years’ experience in managing clinical trials with at least 3 years of experience in clinical operations/project management preferably in oncology programs.
- CRO management experience mandatory, as our trial activities will be performed using an outsourced model.
- Experience in clinical trial regulations (e.g. GCP, ICH), budgeting, health law, operations management, organizational behavior, ethics, and healthcare leadership to guide the clinical operation team.
- Excellent leader and team player; willingness and ability to fill functional gaps in a small organization.
- Ability to lead a team of remote workers in a virtual environment.
- Periodic in-office attendance required.
- Occasional travel required for the position. (<10%)
For immediate consideration please email Tom O'Hanlon, at Tom@Scientificsearch.com and mention Job #17747