Director, Clinical Operations
Our client is a clinical-stage biotechnology company focused on precision oncology. They have asked us to assist them in their search for a Director, Clinical Operations.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Oversees the creation of the Clinical Operations function and its growth over time.
- Designs, implements, and oversees the processes/SOPs necessary to allow for vendor selection, budgeting, contracting, vendor supervision and other key clinical trial activities.
- Leads the selection process for Contract Research Organizations and other supplemental vendors for all clinical activities.
- Attends CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals.
- Provides consistent, regular oversight of CRO and vendor performance.
- Ensures execution of clinical trials in alignment with the protocols, with project timelines, and applicable IND/CTA regulations.
- Monitors spending on all clinical activities and takes corrective actions where needed.
- Partners with Clinical Development leadership and our CRO partners to ensure compliance with global pharmacovigilance requirements.
- May act as designee for Head of Development as appropriate.
- Partners with senior leadership in the further expansion of the organization to facilitate the global development of our pipeline assets.
- Must have a bachelor’s degree minimum of ten years of related experience or a master’s degree in a related discipline and a minimum of eight years of related experience.
- Certification in the assigned area may be required.
- Must have management experience including outsourcing to Contract Research Organizations (CROs).
- Travel may be required up to 20% in support of clinical study activities.
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.
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