We're Hiring

Cognition Therapeutics is built on the tenants of open collaboration, scientific rigor and an unrelenting desire to find solutions to some of medicine’s most challenging diseases: Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease and other disorders of the central nervous system.  If you are interested in joining this dynamic team, we invite you to review the following open positions. If you believe you meet the criteria for the following positions, please email careers@cogrx.com.

Cognition Therapeutics is an equal opportunity employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Open Positions

Position Summary:

The clinical trial associate (CTA) will support the clinical operations department and the clinical project manager (CPM) across multiple clinical trials in the collection and review of essential documents, tracking deliverables and managing the trial master file (TMF). This individual is responsible for ensuring their activities are performed in accordance with clinical operations standards and in compliance with FDA, GCP, ICH guidelines and applicable regulations.

Position Summary:

  • Assist CPMs with various study start-up activities, including tracking and review of study metrics (enrollment, recruitment), protocol deviations, investigator site feasibility status, essential document review and investigational product release.
  • Supports sponsor clinical trial activities including scheduling study team meetings, creating agendas, and managing meeting minutes.
  • Assists in the management and oversight of contract research organizations (CROs), vendors, and contractors, which may include managing correspondence, facilitating team calls (creation or collection of agenda, meeting minutes, action item follow up) and reporting/escalating deliverables to appropriate stakeholders.
  • Coordinates clinical document management activities for multiple studies, including management of sponsor working files and trial master files (TMF).
  • Performs periodic ad hoc, interim, or end-of-study reviews of TMFs, to ensure CRO’s TMFs meets sponsor’s expectations.
  • Supports oversight of trial monitoring activities, which may include tracking/reviewing monitoring visit report (MVR), managing closeout of action items and conducting sponsor directed co-monitoring visits.
  • Supports the development of study related plans such as TMF plans, monitoring plans, project management plans, communication plans, etc.
  • Supports CPM with site/vendor contract execution, vendor payments and overall study budget management.

Education & Experience:

  • Associate’s or bachelor’s degree in a scientific or health-related field is required.
  • Minimum of one-three years of experience in clinical research required.
  • Minimum of one-two years of experience assisting in the management of clinical trials at a pharmaceutical/ biotech company or CRO is preferred.
  • Experience with DIA TMF Reference Model is preferred.
  • Some site monitoring experience is preferred.
  • Understanding of GCP/ ICH guidelines and FDA regulations is required.
  • Experience with various documentation management systems (e.g. eTMF, Clinical Trial Management Systems [CTMS]) preferred).

Computer Skills:

  • Must be proficient in MS Office Suite.
Other Skills and Abilities:
  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects and timelines simultaneously.
  • Excellent organizational skills and attention to detail are required.
  • Strong proofreading, editing, and reviewing skills are needed.
  • Must be able to work independently, participate in meetings and possess problem solving skills.

Travel:

  • The average travel for this position is 15% with some variation based upon the demands of the business imperatives.

Position Summary:

The senior clinical project manager (Sr. CPM) is responsible for leading several clinical project teams; developing comprehensive project plans; timeline/milestone management; and vendor management (including oversight of central laboratories, contract research organizations, and other vendors) across multiple protocols/programs. This individual is responsible for ensuring trials are managed in accordance with company standards and in compliance with FDA, GCP, ICH guidelines and applicable regulations.

Major Responsibilities:

  • Responsible for overall project planning, initiation, conduct and closeout of multiple clinical trials in all phases of development.
  • Leads the development of clinical protocols, amendments, informed consents, CRF/ source documents, protocol specific training documentation, administrative letters, IND safety reports and other written clinical documents.
  • Establishes and maintains productive working relationships with vendors, clinical investigators, and clinical site study staff to ensure quality of deliverables.
  • Responsible for developing and facilitating request for proposals (RFP), bid reviews, and contracting with CROs and other vendors.
  • Responsible for the development and negotiation of trial level and clinical trial site level budgets.
  • Manages contract research organizations (CROs), vendors and contractors to ensure project requirements are met.
  • Responsible for development, maintenance and oversight of project metrics (study start up indicators, actual vs. expected site initiations/enrollment), timelines/milestones, and trial budgets.
  • Oversees data collection and responds to questions from clinical site study staff regarding the protocol and any other study related issues.
  • Ensures that protocol/project training (e.g. Investigator Meeting) for investigators, study coordinators, monitors and other key study personnel is conducted and appropriately documented.
  • Responsible for the oversight of site monitoring activities and review of associated documentation from study initiation through close-out.
  • Responsible for ensuring adequate management of the Trial Master File (TMF).

Education & Experience:

  • A Bachelor’s degree in a scientific or health-related field is required.
  • Minimum of seven to nine years of general clinical research experience, including on-site monitoring experience.
  • Must have a minimum of five to seven years of experience in the management of clinical trials as a project manager at a pharmaceutical/biotech company or CRO.
  • Advanced understanding of GCPs, FDA regulations and ICH guidelines is required.

Computer Skills:

  • Must be proficient in MS Office Suite including Microsoft Project and Excel.

Other Skills and Abilities:

  • Must demonstrate a keen attention to detail and timelines.
  • Excellent writing, communication, and presentation skills.
  • Demonstrated leadership and project management skills.
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
  • Demonstrated ability to stay abreast of trends and new information in the profession.

Travel:

  • The average travel for this position is 20% with some variation based upon the demands of the business imperatives.

Position Summary:

The medical director will report directly to the chief medical officer and will function as the medical monitor of clinical studies, working closely with CROs to achieve study timelines and goals. The medical director will provide strategic input to the clinical development of Cognition’s pipeline of candidates in age-related degenerative diseases.

Major Responsibilities:

  • Design, implement and conduct international clinical development studies to support a US and ex-US regulatory strategy.
  • Contribute knowledge of present and future competitor products and how they impact medial strategy and/or external communications.
  • Work with clinical operations and manufacturing to develop, recommend and adhere to a clinical development budget.
  • Provides input and medical review of clinical documents, including protocols, study reports, statistical analysis plans, publications and clinical sections of regulatory submissions.

Education & Experience:

  • Graduate degree with concentration in neurology; M.D. preferred.
  • 10+ years’ experience in biotechnology drug development or equivalent experience in an academic research role.
  • Experience managing drug development programs.
  • Experience designing, implementing and conducting clinical studies.

Travel:

  • The average travel for this position is 20% with some variation based upon the demands of the business imperatives.
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