Phone: (267) 387-0090
Position Overview
Our client is a clinical stage precision oncology company dedicated to developing targeted therapies for genomically defined, clinically underserved cancers. Our client aims to match the right patient to the right drug, and hope to achieve the promise of precision oncology: deliver better clinical outcomes and greater benefits for patients, caregivers and healthcare providers.
Our client is searching for a remote Clinical Operations Leader who will provide strategic and operational leadership of clinical studies, including leading the creation of the clinical operations strategy and recruitment, and ensure compliance of all regulatory guidelines. This person will lead and build a team of Clinical Operations professionals who will oversee the strategy for implementation and the execution of all sponsored clinical trials. The Vice President Clinical Operations will take the lead on program/compound level responsibilities, including budget forecasting, drug forecasting, and will support efforts in the planning, execution and reporting of all phases of global Oncology clinical trials for early compounds. Additionally, they will be the primary operational contact for the study and lead a clinical cross-functional global team that includes both internal and external resources to support the execution of the study.
Our client is searching for a remote Clinical Operations Leader who will provide strategic and operational leadership of clinical studies, including leading the creation of the clinical operations strategy and recruitment, and ensure compliance of all regulatory guidelines. This person will lead and build a team of Clinical Operations professionals who will oversee the strategy for implementation and the execution of all sponsored clinical trials. The Vice President Clinical Operations will take the lead on program/compound level responsibilities, including budget forecasting, drug forecasting, and will support efforts in the planning, execution and reporting of all phases of global Oncology clinical trials for early compounds. Additionally, they will be the primary operational contact for the study and lead a clinical cross-functional global team that includes both internal and external resources to support the execution of the study.
Job Responsibilities
- Develop the company’s focused clinical study strategy and drive study execution utilizing available resources
- Lead global cross functional Precision Medicine focused therapeutic programs
- Development of the subject recruitment/retention strategy and related initiatives
- Lead the operational strategy for identifying and recruiting patients
- Lead the full-service Contract Research Organizations (CROs) Development/management of vendor scope of work (SOW) per contract, quality, and budget
- Lead the development of clinical and diagnostic SOPs and GCPs; contribute to continuous improvement in SOPs and local Working Practices.
- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions.
- Proactive management of internal partners/stakeholders including Regulatory Affairs, CMC, Project Management, and other affiliates and foster partnerships across existing multi-disciplinary teams
- Strong understanding of the cost drivers, attuned to principles of clinical cost disciplined management and able to proactively manage the study budget
- Oversight of clinical monitoring quality and adherence to established processes and plans
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
- Present at scientific leadership team meetings, investigator meetings and development steering committees, as required.
- Attend or present at study site initiation meetings as needed.
- Liaise with study investigators, research staff, and external partners to support clinical studies and drive enrollment. Be the point of first contact when sites inquire about patient inclusion/exclusion criteria for ongoing trials. Perform external study feasibility with investigators for trials in start-up.
- Patient Recruitment Planning: monitor enrollment, develop recruitment plans, and ensure procedures are in place. Manage patient recruitment strategies to increase patient randomization into the trial.
- Forecast clinical trial (CT) material on a trial and program level, ordering clinical trial material, setting up and monitoring the systems whereby material is shipped to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary.
- Contribute to the preparation and review of clinical program documents and other study related documents assuring quality and consistency.
Job Requirements
- Minimum 12-15 years of Clinical trial management experience required.
- Oncology experience in both solid and liquid tumor required.
- Experience working in both Small Biotech and Large Pharma is highly preferred
- Experience as a team leader will be advantageous
- Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures.
- Ability to mentor and train other team members in a positive and effective manner.
- Ability to evaluate medical data and proficient knowledge of medical terminology.
- Ability to effectively communicate and influence senior level stakeholders to gain buy-in on clinical strategy
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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