Head Of Clinical Operations

ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics with curative potential for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple drug candidates targeting solid tumors and hematological malignancies that are in discovery, preclinical, and clinical development stages. ProfoundBio is headquartered in the greaterSeattlearea and has operations in Suzhou and Shanghai China.

ProfoundBio is seeking a Head of Clinical Operations, to build and develop the clinical operations team and infrastructure in support of ProfoundBio’s two clinical-stage programs and early-stage pipeline.This role will report directly to the Chief Medical Officer and will be integral in the success of ProfoundBio’s clinical trials.

Responsibilities:

• Provide oversight, subject matter expertise and support to all levels of staff on assigned program and studies as needed to ensure efficient and effective operational execution
• Ensure program risk and issues affecting safety, timelines, budget or quality are identified and resolved or mitigated appropriately
• Manage all operational aspects of the clinical development program including oversight for timelines, budget, quality, resourcing, and risk management across a range of complex studies.The Head of Clinical Operations must have open, effective and proactive communication of critical activities to ensure the success of ProfoundBio’s clinical programs.
• Leads efforts to establish preferred vendor relationships and define criteria for vendor performance evaluation
• Guides efforts to identify, select, contract and monitor vendor performance across a range of studies and programs
• Identify gaps in company/CRO SOPs and work with key stakeholders to develop SOPs as needed
• Set and manage Clinical Operations budget
• Develop and maintain oversight relationship of CRO and serve as the point of contact for issue escalation
• Oversee execution of clinical studies across the program
• Support the building of department infrastructure, including developing, training, and retaining key members of the clinical operations team; ensure prioritization of activities and resourcing is in line with clinical development programs

Qualifications:

• 10+ years progressively responsible experience in biopharmaceutical clinical trials, with an extensive portion supporting oncology and/or immuno-oncology programs
• Bachelor’s degree in a relevant field scientific field, with advanced degree or nursing degree preferred

Skills:

• Ability to support meetings in ex-US time zones
• Strong team player with demonstrated track record of success in a cross-functional team and fast-moving environment
• Track record of establishing GCP compliant environments on clinical programs across a range of phases
• Familiar with advanced concepts of clinical research (including complex study designs)
• Able to recognize need(s), find solutions and take initiative to address in proactive manner
• Strong organizational skill set with attention to detail in order to manage multiple complex workstreams and prioritize work according to corporate goals
• Expertise in MS Office and project management timeline/Gantt software (MS Project and/or Smartsheet), experience with SharePoint, data capture and analytics software
• Proven ability to provide scientific and clinical expertise to a clinical development program.
• Highly collaborative with outstanding communication, time management and facilitation skills
• Demonstrated experienced in oversight of CROs and other contract clinical trial support vendors

This position may require up to 10% domestic travel and limited international travel. Remote candidates may have more domestic travel in order to accommodate periodic team meetings in the greater Seattle area.