Associate Director, Clinical Operations

Posted 1.26.24
Location
New York, NY

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. 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 in life sciences, health care or related discipline.
  • 8+ years experience as a “Clinical Trial Manager” in biotech, pharma, or CRO setting.
  • Must have a deep knowledge of Clinical Trial conduct and the regulatory requirements.
  • 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 10%, 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.

Compensation:

The base salary range for this position is between: $168,500 – $190,000. The final base salary will be dependent upon skills, experience and location. In addition to the base salary, Click Therapeutics offers an annual performance-based cash bonus and a generous equity package.

Benefits:

The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space. 

Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5% 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Fitness Reimbursement | Bike Membership | Professional Development Stipend | Lunch Stipends | Parent Benefits | LinkedIn Learning | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Choice of Mac or Windows | Sponsored Company Events | 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.

Recruitment Phishing Scams:

Fake job advertisements and offers are increasingly appearing on the internet. If you have encountered a job posting or have been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond and report it to the Federal Trade Commission and the FBI at https://www.ic3.gov/Home/ComplaintChoice.You can also contact our team at recruitment@clicktherapeutics.com to report details of your experience.

Please be mindful of the following:

  • Click Therapeutics will only reach out to you through an “@clicktherapeutics.com” email address.

  • Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver’s License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams).

  • Click Therapeutics will conduct interviews face-to-face over Zoom.

  • All job postings will be listed on the Click Therapeutics official career page. If someone contacts you about a job or position that is not listed on the official career page, please contact the Click Therapeutics recruitment team at the contact information below.

If you have any questions regarding the validity of a recruitment inquiry or an interview, please contact the Click’s recruitment team at recruitment@clicktherapeutics.com to confirm before proceeding.

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