Senior Director Clinical Operations
$200,000 - $280,000 Annual Salary Based on Experience + Competitive Bonus
The Senior Director Clinical Operations will be responsible for managing all operational functions of clinical trials & study management at an impressive Biotech. Oversight of trials & CRO work with adherence to GCP & ICH guidelines, ensuring inecption readiness. They will be an experienced Clinical Operations leader who is eager & motivated to be part of the team advancing care forward.
Responsibilities include but are not limited to:
Responsible for the management of all clinical operations & study activities & personnel following them. From compliance to adherence of deadlines.
Vendor management & oversight for all studies managed by the vendor.
Establish and drive a team of internal and external multi-functional stakeholders ; evaluate and develop ideal outsourcing model for delivery on clinical portfolio, including oversight of CROs and other vendors/external partners.
Represent Clinical Operations group at cross functional meetings.
Provide input for any clinical audits & inspections alongside quality team.
Authoring & revising SOPs.
Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timeline projection, drug and budget forecast, safety plan, monitoring plan, study management plan, issue escalation and resolution plan).
Providing needed training to ensure deliverables are properly met.
Ensures comprehensive operational input to Clinical Strategy with other stakeholders.
BS/BA degree or equivalent in health related field. *An advanced degree is preferred.
8+ Years in the Clinical Operations space within Biotech/Pharma industry.
Leadership experience managing clinical trials.
Strong understanding of ICH, GCP, and relevant regulatory requirements
Global clinical trial conduct and clinical operations experience, from start-up to database lock. A thorough understanding of the processes associated with project and study management.
Leadership skills & innovative mindset.