Head of Clinical Operations

Job Description:

• Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO/vendor selection, contracts & budgets, CRO/vendor oversight, and proactive risk management to ensure the quality conduct of trials with a high level of quality and data integrity
• Responsible for the successful planning and execution of Phase 2 and 3 trials
• Proactively builds and strengthens site and Investigator relationships and actively cultivates site engagement
• Work cross functionally to drive strategy, oversee the implementation of all clinical programs, and manage the integrated development plans to deliver against company goals
• Proactively identify potential risks and develop and implement actions and plans to avoid or mitigate program risks and make appropriate plan to balance risks, deliverables, and costs
• Lead and supervise all aspects of study progress from concept to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines; heavy emphasis on late-stage development experience
• Develops and optimizes critical SOPs needed for program success, inspection readiness and compliance
• Oversee identification, qualification, and selection of CROs and vendors needed to conduct clinical trials including approval of Master Services Agreements and Task Orders with CRO
• Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
• Provide scientific/clinical expertise in the design and interpretation of clinical studies
• Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
• Provide direct line management and training/mentoring of Clinical Operations team members
• Ensure clinical operation team are trained in regulatory inspection process and develop a pro-active approach for inspection readiness
• Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources
• Create and oversee clinical program budget(s) and long-range clinical planning/forecasting activities
• Ensure there is proper oversight of identified safety concerns and/or adverse events; develop and implement corrective actions accordingly, and participate in internal/external study related audits, as needed
• Contribute as required to the authoring of key regulatory documents, study protocols, investigator’s brochures, IND reports, study postings, ensuring document and operating standards are established and maintained
• Participate in business development and process improvement/quality initiatives, as needed

Requirements:

• Bachelor's Degree in a scientific discipline; with a minimum of 12-15 years clinical development experience.
• Extensive clinical operations management experience, including program leadership or TA leadership at a minimum
• Proven excellence in clinical operations strategy and execution, including Ph I-IV studies, global clinical trial operations, and multiple clinical trials simultaneously. Experience in Respiratory/Pulmonary diseases preferred
• Hands-on, detail-oriented leader with operational fluency
• Demonstrated ability to set and prioritize goals and objectives, excellent time management, negotiation, problem-solving and organizational skills
• Experience in building infrastructure (including SOPs) required
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Strong leadership skills with ability to innovate and collaborate with a small team to articulate clear clinical strategy. Strong coaching and mentoring skills leading to the success and development of subordinates
• Willingness/ability to travel (domestic and international)

Benefits:

• Equal employment opportunities for all employees and applicants without discrimination
• Prohibits discrimination and harassment of any type

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