Director/Senior Director, Clinical Operations
Our client is a clinical-stage pharmaceutical company. They have asked us to assist them in their search for a Director/Senior Director, Clinical Operations
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Coordinates and actively participates in the development and updating of study-related documents (investigator brochures, clinical protocols, ICFs, CRFs, CSRs, etc.).
- Builds and executes strategics for patient enrollment to include sourcing, selecting contracting, and oversight of specific vendors related to patient recruitment and retention.
- Develops clinical trial budget forecasts based on anticipated scope, timelines, and resource requirements.
- Ensures the collection of high-quality clinical data; support and/or participates in the analysis of clinical data.
- Works in a collaborative manner with cross-functional teams to accomplish agreed upon deliverables by driving organizational best practices.
- Monitors trial progression against agreed targets, identifies risks to study execution in a timely manner, and ensures active management and implementation of risk mitigation strategies with CROs and other key vendors.
- Represents the company in the global medical research community and develops collaborative relationships with study Principal Investigators and other stakeholders.
- Ensures that adequate internal and external resources are allocated to the clinical projects.
- Bachelor’s and/or Master’s degree in a scientific discipline required; or equivalent combination of education and applicable experience.
- Must have a minimum of 8+ years of clinical operations experience in the pharmaceutical or biotech industry, and a minimum of 5+ years of experience in a project-lead or leadership capacity.
- A complete understanding and application of principles, concepts and practices of clinical research procedures and good clinical practice (GCP) is required.
- Oncology experience is highly preferred.
- Requires experience managing clinical trials through CROs and external vendors.
- The demonstrated ability to select CROs and other vendors for clinical trials is required.
- Experience with all phases of clinical drug development including global regulatory submissions highly preferred.
- Requires the ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.