Director, Clinical Development (Migraine)

Medical, Clinical & Science         ·          New York, NY        ·       Full time

Who We Are:

Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for patients 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 has entered a pivotal, fully remote, randomized, controlled trial on the Verily platform for the treatment of Major Depressive Disorder (MDD) in up to 360 adults. Click is progressing a broad pipeline of Digital Therapeutics™ across a variety of high-burden therapeutic areas, including MDD, Schizophrenia, Migraine, MS, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome (ACS), Obesity, Oncology and more.

About the Role:

Click Therapeutics is seeking an innovative clinical development scientist and/or physician who wants to pioneer the future of medicine with digital therapeutics in the field of Neurology. In this role, the Clinical Director will oversee clinical development plans including Phase III and Phase IV study designs, inform planning and execution of clinical trials, and lead safety and digital vigilance efforts, while also engaging in regulatory, R&D, and business development activities.

This position is based out of Click’s headquarters in located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities.

Responsibilities:

• Serves as the lead scientist / physician for clinical development of Migraine and other DTx in the organization and provides key medical expertise and input in support of pipeline development and management.
• Will be responsible for design and execution of assigned clinical trial activities and work closely with cross functional team members within the assigned project to execute activities associated with the conduct
• Translating strategic objectives and concepts from Clinical Science and Medical Teams into robust clinical development plans for Medical Device approval
• Provide regular and timely updates to manager/management as requested
• Develop Protocol and ICF documents / amendments and present these to development team meetings as required
• Review clinical narratives, conduct literature review, monitor clinical data for specific trends
• Submit clinical documents to TMF
• With Clinical Operations develop site and CRA training materials and present these at SIVs and Investigator meetings
• Develop Data Review Plan in collaboration with Data Management and Stats
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, IRB responses and contribute to regulatory submission.)
• Capabilities to identify critical clinical insights & use these to guide study design strategies from initial concept through to study outline, extended synopsis and into Protocol development where required.
• Working across all types of medical projects including Phase II and Phase III clinical studies, digital and virtual trials, perform meta-analysis and develop consensus papers etc.
• Promote clinical innovation opportunities and leverage latest clinical methodology knowledge to develop robust and effective study concepts both conventional and novel virtual and digital trials
• Delivery a best-in-class high impact brand-aligned clinical plan on medical commitments to desired outcomes & milestones
• Presentation of trial protocols to the appropriate approval committee
• Ensure an external focus, including liaising with external experts or investigators on conducting the trial
• Review and finalization of reports and occasionally manuscripts for publication
• Updates of the company core data sheets and target product profile of assigned products with the latest results from clinical trials
• Actively collaboration within Medical Affairs, Clinical Science, Clinical Operations and Clinical Strategy & Innovations groups and across Click (e.g., marketing, product development, pharmacovigilance, regulatory)
• Compliance with company standards & local regulations
• Other functional skills
  • knowledge of products/product categories (Psychiatry & Neurology) and related disease conditions.
  • Knowledge of how health and wellness are managed in current healthcare environment
  • Able to gather, interpret and generate clinical and scientific data (e.g., structured, and non-structured) to support medical and business objectives.
  • Able to identify and address clinical and scientific gaps and to co-develop the business case to address gaps.

Qualifications:

• Medical degree (MD, DO, or MBBS) and 5+ years bio/pharma/DTx industry experience in Neuro, CNS therapeutic development or equivalent. Doctoral Degree in Life Sciences (PharmD, PhDs) with strong clinical development background can also be considered
• Neurologist with a clinical experience strongly preferred
• Demonstrated expertise in therapeutic development process including technical, business, and regulatory issues
• 5+ (Director) Years of pharma experience preferred
• Experience running complex clinical research programs is a plus
• Comfortable maintaining a high level of clinical and scientific expertise in the relevant disease area(s) by reviewing the literature, attending medical/scientific meetings, and through interactions with consultants, thought leaders, investigators, and internal stakeholders
• Ability to influence without authority, lead change, and manage resistance to change.
• Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations is essential
• Excellent communication and presentation skills
• Innovative, flexible mindset
• Team player, with ability to work successfully across function

Preferred Qualifications: 

• Knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to understand assigned protocol(s) and their requirements
• Basic knowledge of disease area, compound, current clinical landscape
• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Intermediate critical thinking and problem-solving skills
• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)

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. 

Stock options | Competitive Salary with Annual Review | 5% 401(k) matching | Annual Performance-Based Cash Bonus | Comprehensive Medical Benefits | Dental | Vision | Voluntary Benefits | Unlimited Vacation Time | Uber One | Nectar Rewards | One Medical | Fertility Support | Gym Pass | Citi Bike | Professional Development Stipend | Industrious Workspaces | Generous Paid Parental Leave | Commuter Subsidies | Monthly Lunch Stipend | Monthly Catered Lunches | Choice of Mac or Windows | 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.

Please click here to apply.