Job Details

Overview

The Director, Clinical Operations will oversee the execution of clinical trials within the development programs. The incumbent will serve as the governance contact for the CRO and clinical vendors, ensuring that all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs, and business guidelines.

Responsibilities

1. Provides strategic input to the clinical development plan.
2. Develops the operational plans for trials within the assigned development program(s).
3. Oversees trial execution team to ensure delivery of clinical trial within budget and agreed upon timelines.
4. Identifies and/or anticipates operational risks and mitigation plans across trials within the development program and escalates issues to senior management as necessary.
5. Manages the quality of work performed by direct reports (i.e. AD, CTM, CRA, and CTC) through regular review and evaluation of work product, acting as a coach and mentor.
6. Serves as the relationship manager for CRO/Vendors and is a member of the joint oversight committee.
7. Reviews CRO/Vendor agreements and negotiates the performance metrics to be outlined within the agreements.
8. Contributes to Global clinical/regulatory submissions.
9. May perform periodic visits to sites and/or vendors to assess progress and compliance.
10. Presents status reports of operational execution activities to senior management.
11. Ensures clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.

Qualifications

1. 10 years of clinical operations experience in a pharmaceutical, biotech, and/or contract research organization (CRO) setting; including management of a CRO.
2. 7 years supervisory experience, 5 years direct project/trial management experience, and 2 years in a leadership role.
3. Strong collaborator with excellent communication skills; “Can do” attitude.
4. Requires a BS in the health or life sciences or equivalent.
5. Oncology experience is highly preferred.
6. Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) required.
7. Good working knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required; basic statistical knowledge preferred.
8. Excellent computer skills (Microsoft Office Suite, Project, Outlook; Electronic Data Capture and Trial Master File Systems).
9. Global Clinical Trial Experience and the ability to support more than one clinical trial is required.

Work Environment

The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.