Description
Sr. Director, Clinical OperationsReporting to the VP of Clinical Operations, the Director/Senior Director will lead all the Clinical Study Teams to achieve clinical studies deliverables working with both in house and CRO Clinical Program Managers and CRAs. The candidate will oversee program level execution of all Clinical Development and Clinical Operations deliverables, and leads the Clinical Operations team to meet the clinical department goal and objectives. He/She will represent clinical operations on the Project Teams.
Primary Responsibilities:
- Initiate and lead clinical study teams as clinical director. Responsible for the successful operations of all study teams to achieve the study objectives at the highest standards and on time and budget. He/she will assist in protocol writing to completion, site selection, and working with internal managers/CRA's and CRO's depending on the study to deliver patients, data, analysis, up until finalization of Clinical Study Report (CSR). All tasks and activities will be conducted full compliance with regulatory requirements, GCP, good medical practice, and SOP's.
- Supervise all study activities, with the CT team members in terms of study initiation, the data collection activities, and site management. Monitors adherence to protocols and study timelines.
- Identifies program risks; proactively creates and implements mitigation strategies. Provide Sr. Management with necessary reports on progress and changes in scope, schedule and resources in a timely manner including preparation of presentations and documents to the R&D Strategy Committee
- Works with internal team members in the development and implementation of compliance programs for Clinical Trials, including SOP's.
- Manage high performing teams of Clinical Program Managers and CRA's to achieve their goals and objectives as it relates to the different clinical studies objectives. Must be able to manage and develop people
- Develop relationships with key thought leaders to support product development, he or she will represent The company externally in applicable scientific and medical forums. Must be able to manage and develop people. Performs job duties with minimal guidance and has sound critical thinking and problem solving skills.
Travel approximately 20% of the time
At least 10+ years managing clinical science/operations/development in a pharmaceutical and/or biotechnology company demonstrating a broad background in those environments.
At least 5+ years of experience managing other clinical operations/development staff. Ability to manage the needs of multiple internal and external partners and deploy resources to meet those needs.
Prior Experience managing oncology or hematology trials is a must. Knowledge of key opinion leaders in the areas of oncology/hematology will be highly valuable.
Familiar and comfortable with clinical concepts, practices and FDA regulations regarding clinical research trials. Also familiar with data processing methods, general knowledge of clinical medicine, oncology, and medical terminology.
He or she will have excellent leadership, performance management, communication skills and strong organizational skills.
Benefits:
We provide a comprehensive benefits package to include medical, vision, dental, short and long term disability, group term life, 401(k) and an Employee Assistance Program.
If this position seems like a good fit for your career goals and skill set, please send me an updated resume. If this is not exactly what you are looking for, but are interested in other positions within the pharmaceutical space, please reach out to me as I specialize in placing candidates within this industry.
If you have a colleague who you think would be a good fit for this position, please feel free to forward this message along.
To find out more about Real Staffing please visit www.realstaffing.com