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 fully remote execution of a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Click also has major pipeline expansion and progression in multiple therapeutic areas.

About the Role

The Associate Director, Clinical Operations (AD, Clin Ops) reports directly to the VP, Clinical Operations and is responsible for the planning and execution of remote and decentralized clinical research studies. This position will provide operational leadership for multiple clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP and applicable SOPs.  This role will be responsible for managing all operational aspects for implementation of clinical trial activities from study start-up through database lock. The AD, Clin Ops will manage and serve as the primary point of contact for all service providers. The AD, Clin Ops should have strong critical thinking skills for problem solving and have strategic thinking capacity to drive study decisions that affect study outcomes and timelines.

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 is located in our trendy Tribeca HQ, includes great benefits, and is an excellent wealth-building/equity opportunity for the right individual.

Responsibilities

• Assumes overall responsibility for development of protocols, recruitment strategies and mitigation activities to increase patient randomization, monitoring plans and data management oversight; IRB/Ethics committee approval and management of vendors and study site the trial contracts across multiple programs
• Manage clinical trial personnel in study conduct as well as career development; direct reports include CTM, CRA, CTA, CRC
• Participates in protocol and strategy development, Clinical Study Report preparation, NDA submission, as appropriate
• Prepares metrics and updates for management
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Participates in and facilitates CRO/vendor selection process for outsourced activities
• Identifies and coordinates study specific training for clinical staff and cross functional personnel for protocol execution, adverse event reporting and pharmacovigilance.
• Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• Recommends and implements innovative process ideas to impact clinical trials management
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
• Has responsibility for the financial management of the clinical trial in conjunction with the finance department.
• Establishes procedures to ensure adherence to trial protocols and administrative requirements and manages the tracking of timeline milestones
• Acts as the point of contact for all external and cross functional teams
• Participates in the authoring and review of SOPs and Work Instructions

Qualifications

• Bachelor's Degree required / Advanced Degree preferred in life sciences, health care or related discipline
• 6+ years experience as a “Clinical Trial Manager” in biotech, pharma, or CRO setting
• Experience with validated mental health scales
• Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials
• Experience with both early and late phase clinical trials
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology
• Ability to deliver results and execute on required activities individually, in a team setting
• Organized and detail-oriented
• Strong negotiating skills in a compact clinical team working with aggressive timelines
• Ability to travel up to 20%, generally within the US
• Highly responsive and proactive, a team player
• Initiative, enthusiasm and a problem-solving approach to new challenges.
• Systematic and efficient coordination skills, including an ability to prioritize.

Benefits

Stock options | Competitive salary with annual review | 401(k) matching | Annual performance-based cash bonus | Comprehensive medical benefits through Aetna | Flexible Spending Accounts | Life insurance and disability benefits | Open vacation policy / unlimited PTO | Generous paid parental leave | Commuter subsidies | Monthly catered lunches | Choice of Mac, Windows, or Linux equipment | Sponsored company events | Free, unlimited office snacks and beverages | Much more…

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.