Clinical Operations Director/Sr.Director

2 weeks ago

Houston, United States CARsgen Therapeutics Full time

Responsibilities

1、Ensure clinical trials are conducted according to GCP guidelines and all applicable regulatory requirements, SOPs, and other quality standards.

2、Develop scalable infrastructure with an emphasis on implementation and use of harmonized, consistent processes and excellence in study management deliverables related to cost effective, timely and high-quality clinical trial data.

3、Contributes to the creation of internal SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & EMA regulations; evaluates and recommends changes to policies or procedures.

4、Effectively communicate clinical trial updates to the Executive Leadership, and other appropriate functional groups.

5、Strategic Resource and Cost Efficiency Analysis

5.1 Collaborate with cross functional teams to develop scenario-based planning to forecast resource and budget needs to contribute to the clinical development plan and execution.

5.2 Regularly conduct in-depth strategic analysis of resource allocation, utilization, and cost efficiency across all clinical trials.

5.3 Establish and monitor key measures on resource efficiency and cost management. Use these benchmarks to evaluate the effectiveness of clinical operations, identifying opportunities to enhance efficiency while maintaining or improving quality.

6、Act as the escalation point for Clinical Project Managers; directly supervise and manage personnel as needed.

6.1 Provide direction and leadership in CRO and Vendor selection and management.

6.2 Develop clinical trial budget forecasts by working closely with the global project management and procurement teams.

6.3 Serve as the Subject Matter Expert (SME) on study protocol and operations and ensure proper training and education to internal and external resources.

7、Approve and allocate clinical operations resources based on business priorities.

8、Work collaboratively with cross-functional personnel to accomplish agreed upon deliverables.


Qualification

1、Bachelor’s and/or master’s degree in sciences, health, or related area. Advanced degree is preferred.

2、10+ years of pharmaceutical or biotech-related/clinical research experience. Oncology/immuno-oncology experience is required.

3、Strong leadership skills. At least 8 years of management experience.

4、Exceptional written and verbal communication skills.

5、Working knowledge of the processes required to operationally execute clinical trials.

6、Strong understanding of FDA regulations, GCP, ICH guidelines and clinical research SOPs.

7、Demonstrated capability to proactively manage vendor-supplied resources.

8、Experience interacting with internal and external stakeholders.

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