Overview

Reference Number: JO-1904-429474
Senior Director of Clinical Operations
Rate: Negotiable
Job Type: Permanent
Location: Washington

Senior Director of Clinical Operations

We are working with a leading oncology biotech in the Washington DC area which is advancing its solid tumor pipeline and requires a Senior Clinical Operations Director to drive this program forward.

This role will offer the successful candidate a great opportunity both to move an excellent clinical development program towards producing much needed therapies for difficult diseases and this will provide an excellent career track for an ambitious individual.

Responsibilities and Job Duties
• Contributes to the strategic direction, execution and overall capabilities of the clinical development department as a member of the senior leadership team.
• Develops and implements an integrated program that serves to connect clinical study strategy with high-quality investigational sites ideally suited to collaborate in the design and execution of patient trials. Initiate and lead monitoring oversight activities that are conducted in accordance to ICH/GCP standards
• Provides guidance and oversight for the successful development and management of all aspects of US and International clinical trials within designated program budgets and timelines which support regulatory approvals. Incorporates key decision points and Go/No Go criteria for Clinical Development Plans (CDP). Partners with functional peers to manage, adjust, and revise project timelines and budgets as necessary.
• Facilitates the recruitment of high-quality, high-performing study sites to support clinical trial execution and leads strategies for direct patient recruitment into clinical trials.
• Oversees the clinical operation team in planning, conducting and evaluating clinical trials. Ensures weekly/biweekly planning/tracking updates applied; critically review plan periodically to address any emerging issues. Ensures continuity and consistency across studies within a given project. Oversees budgeting for all clinical programs and in collaboration with operational staff and finance department, the tracking of clinical trial costs/expenses
• Prepares and presents clinical development trial updates to senior management. Identifies and communicates clinical development risks and mitigation strategies as they relate to clinical trial program. Communicates project status and issues to management and other team members and ensures that project team goals are met
• Reviews and approves all clinical study conduct documents including study concept document, relevant manuals, protocol, IB, ICF, CRF (and eCRF), site monitoring documents, data management plan, study monitoring plan, safety monitoring plan, AE reports and CSR as appropriate.
• Participates in the selection and management activities of CROs. Provides oversight of processes, monitoring and quality assurance of investigative sites for the study. Develops strategy and action plans to resolve issues or problems that arise to expedite resolution.

Oncology experience is essential in this role and they would prefer a candidate with an advanced life sciences degree. The successful applicant will get a strong salary, bonus and stock options.

For more information please CLICK APPLY and forward an up to date resume.

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