This is an amazing with a growing Biotech company in San Diego!

Here is the job description:

Summary

Join an experienced team with a track record of success! The successful candidate will oversee and direct all clinical studies, including timelines, budgets, cross-functional logistics and resources. This person will have management responsibility for internal Clinical Operations staff, as well as external contract organizations and functional services providers. Reports to the Chief Clinical Development and Operations.

Essential Duties and Responsibilities

Actively provides direction and oversight of clinical trials

Provides leadership and training to clinical operations staff

Leads CRO, critical vendor (e.g., clinical database, IRT/IXRS, laboratories) selection process for outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met

Oversees the clinical site feasibility, qualification and selection process

Supports the forecast and management of project/program budgets, including long range forecasting of clinical trial and FTE costs

Develops and executes operational procedural plans

Provides input on study strategy and protocol development

Assists in the development of CRF and EDC software specifications, and validation

Prepares or reviews and approves study materials such as informed consent form templates, diaries, drug accountability forms, study manuals, and study plans

Manages clinical trial meetings with clinical staff and upper management on patient recruitment trial issues and presents plans for issue resolution

Identifies clinical program/resource gaps and performs project risk analyses, and implements solutions

Ensures deliverables, timelines, and budgets for clinical sites, CROs and vendors are established, visible to the company, and achieved

Participates as an active member on Global Program team to discuss program strategy and critical operational issues

Supports development of clinical operations quality systems, including standard operating procedures, document management, personnel training, and quality control processes. Supports development of department goals and objectives

Other duties as assigned

Travel up to 25% of the time.

Competencies

Organizing - Aligns resources effectively and efficiently to get things done. Orchestrates many activities at once with high attention to detail. Arranges information and files in a useful manner.

Problem Solving - Uses logic and methods to solve difficult problems with effective solutions. Looks beyond the obvious and doesn’t stop at the first answer.

Decision Quality - Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment. Most solutions turn out to be correct and accurate when judged over time.

Teamwork/ Interpersonal Savvy. Relates well to all people, both within and outside of the Company. Builds an appropriate rapport and constructive relationships. Uses diplomacy and tact.

Written and Verbal Communication - Able to write and speak clearly and succinctly in a variety of communication settings and styles. Get messages across with the desired effect.

Work Environment and Conditions

Position is principally located in an office and requires extended periods of sitting.

Position Type and Expected Work Hours

This is a full-time position, typically scheduled to work Monday through Friday. Travel may require working on weekends and in the evening.

Education and Experience

BS required, or MS, PharmD or PhD, in a scientific discipline is preferred. Minimum of 8 years of relevant oncology experience in clinical operations with a thorough understanding of cross functional clinical processes including clinical product supply, data management, biostatistics, and medical writing

At least 3 years of clinical operations line management experience

Strong working knowledge in Good Clinical Practices and ICH Guideline and the application to the conduct of clinical trials

Experience in both US and Ex-US clinical study management with track record of successfully managing multiple projects, trials and priorities

Proven ability to provide highly organized and detail focused oversight to the execution of clinical studies

Ability to work effectively in a collaborative cross-functional team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view

Independently motivated, detail oriented and good problem-solving ability

Excellent organizational skills, with a high attention to detail and an ability to embrace change and multi-task in an extremely fast-paced environment

Willing to travel to support clinical and corporate activities

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