Associate Director, Clinical Operations

Who We Are:

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn. 

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 position is based out of Click’s headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities or at one of our industrious offices in Boston, MA or Miami, FL. We have a hybrid working model that consists of at least 3 days in office each week.

Responsibilities:

• Assumes overall responsibility for 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 multiple CTMs; Indirect Reports include CRA, CTA, CRC personnel.
• Participates in protocol and strategy development and Clinical Study Report preparation in combination with the Medical Writing team.
• Prepares metrics and study 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