Senior Director Clinical Operations
Title: Director/Senior Director of Clinical Operations
Location: SoHo, New York City, United States
Who We Are:
Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Major pipeline expansion and progression is expected.
About The Role:
We are looking for a Senior Director of Clinical Operations to provide strategic direction and leadership for the execution of clinical trials for digital therapeutics. The successful candidate will also be responsible for the day to day management of clinical operations. This role will ensure the delivery of appropriately skilled resources so that trials are delivered according to Click’s objectives. The Senior Director will provide strategic direction and leadership for the execution of trials and ensure successful delivery of clinical study milestones. This role will also oversee vendor activities with appropriate risk mitigations and contingency planning.
This is a highly visible, creative, and agile role within a rapidly growing pre-IPO company in a nascent and fast-growing space. The role will be located in our trendy SoHo HQ, includes great benefits, and is an excellent wealth-building/equity opportunity for the right individual.
• Develop and manage integrated study timelines and leads study operational meetings to review trial status/progress
• Provide input on strategy in the development of realistic project milestones and deliverables
• Apply appropriate project management tools and processes
• Participate in resource allocation, prioritization and budgeting to ensure department goals and milestones are aligned and tracking to corporate objectives
• Line management responsibilities include hiring talent, performance development and mentorship
• Ensure ongoing strong vendor interactions and collaborations, including hands-on interactions and management
• Drive selection of vendors and vendor project organization
• Provide vendor, principal investigator and project team management, oversight & communication
• Serve as primary contact for functional area representatives in managing protocol execution
• Thorough understanding of the processes associated with executing a clinical development program including: clinical trial design, implementation, management and reporting
• Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
• A minimum of 10 years of Clinical operations experience within the Biotech/Pharmaceutical industry
• A minimum of 5 years of staff management and vendor management experience
• Experience in direct or matrix management of clinical operations team member(s)
• Advanced leadership, project management, resource management, administrative and technical capabilities
• Excellent verbal and written communication skills
• Experience with both early and late phase clinical trials
• Advanced or clinical degree in health care, life sciences, or related discipline preferred
• Therapeutic experience in CNS preferred
For immediate consideration please send your CV as an attachment to: email@example.com
Equal Employment Opportunity
Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics.