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 Apply tot his job Apply tot his job