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 firstname.lastname@example.org.
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.
Position Summary:This position will serve as the medical lead for Cognition Therapeutics’ CNS programs and will be accountable for deliverables of the assigned program(s), supporting resourcing, budget and timelines of these programs. This role serves as scientific and medical lead for the clinical team(s), working closely with clinical operations and reporting to the chief medical officer (CMO). The position requires expertise in clinical development, understanding of the particular challenges of neurodegenerative disorders, and outstanding clinical and scientific knowledge applicable to clinical research. In addition, they will possess the highest personal and ethical standards and will serve as a clinical role model for the team.
In conjunction with the CMO, this position will be responsible for the design and execution of proof-of-concept through registration-enabling studies, as well as supporting specialty physiology studies. The medical director will represent Cognition Therapeutics and build relationships with study sites, development partners and the medical/scientific community.
- Serve as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., R&D), and internal decision boards (senior management and board of directors).
- Develop unique and innovative clinical strategies to improve clinical development through faster studies and/or novel outcome measures.
- Design, draft and/or support Phase 2/3 clinical programs.
- Partner with clinical operations to support all aspects of clinical trials including study concept, protocol development, site identification, investigator meetings, medical monitoring, safety, data review and interpretation.
- Work with the R&D team to provide insight on next generation pipeline compounds.
- Lead the drug safety program, focusing on events, reporting and surveillance of patients in clinical studies.
- Plan and execute publication and clinical communication strategy in coordination with Cognition’s communications, R&D and IR/PR teams.
- Provide input to key external medical/scientific meeting presentations; draft papers for journal publication.
- In conjunction with quality and regulatory teams, ensure the quality of all clinical documents (e.g., investigators’ brochure, protocol, study report, clinical components of regulatory submissions, safety related documents).
- Work with regulatory teams to lend clinical expertise to responses to regulatory agency questions and regulatory submission documents
- Ability to work with multi-functional and multi-disciplinary teams; interface with junior and senior team members.
- Ability to interact skillfully with investigators, site coordinators, collaborators, CROs, foundations and institutes, other biotech/pharma companies, granting agencies, partners and regulatory agencies.
- Strong writing and presentation skills.
- An advanced degree in medicine (i.e., M.D. or D.O. or equivalent) with experience in CNS related disorders and a minimum of 5 years of industry experience; however, a candidate with a strong academic background and less experience may be considered.
Location & Travel:
- The medical director must be able to work from the Purchase, NY offices and be willing to travel to clinical study sites and national and international relevant medical and scientific meetings.
Position Summary:This newly created position will lead all financial reporting and analysis activities across the business and perform other finance related activities. Responsible for all SEC filings, periodic forecasts, and annual budget. Must bring a finance mindset to all company initiatives and work cross functionally throughout Cognition. Utilize advanced IT skills to leverage information systems to obtain financial and non-financial information to enable rapid decision making.
- Preparation of all SEC financial documents including Forms 10-K, 10-Q, 8-K, press releases and annual proxy statements.
- Responsible for all financial analysis of the business including forecasts and budget. Establish framework for analyzing grants, preclinical and clinical study forecasts, and support all G&A functions. Establish core business KPIs.
- Support preparation of federal, state and forecast tax filings.
- Work closely with controller to maintain system of internal controls across the business. Lead efforts to establish SOX – 404 procedures.
- Manage equity administration of stock award activity, including grants, exercises, and terminations using equity administration software. Serve as liaison for employees and non- employees for questions regarding their equity holdings.
- Responsible for contracts and grant administration oversee the maintenance, updating, and editing of the master list of company contracts and monitor related financial obligations to ensure compliance with agreement and proper accounting under US GAAP.
- Support the chief financial officer and executive leadership as a key contributor to the Company’s strategic plan and ongoing business strategy.
- Leverage financial information system to deliver financial results with analysis timely to executive team.
- Prepare board and committee packages and presentations. Perform competitive analysis, benchmarking, and other external IR analyses.
- Demonstrated ability to combine disparate data sets to analyze complex business problems.
- Develop relationships throughout the company and spend time with each of the key stakeholder groups and individuals within those groups to get an understanding of each team’s go-to-market strategy and product development challenges.
- Develop, optimize, and standardize FP&A processes, including through coordination of automation opportunities and sharing of industry best practices.
- Provide accounting support in connection with the monthly close process.
- Perform other duties and ad-hoc projects as assigned.
Education & Experience:
- CPA/MBA preferred.
- 7-10 years combined experience at a Big-4 accounting firm and in finance in a biotechnology/pharma business.
- Excellent verbal and written communication skills, organizational skills, and attention to detail.
- Proficient in Microsoft Office Suite, including Excel, PowerPoint.
- Excellent Bachelor’s degree in Accounting, Finance, or Business Administration required Possession of MBA/CPA or in progress, preferred.
- Experience working with QuickBooks and / or NetSuite a requirement without exception.
Travel & Other:
- The average travel for this position is 10% with some variation based upon the demands of the business imperatives.
- References and background check required.
Other Skills & Abilities:
- Candidates for this role will demonstrate knowledge of the biotech/pharmaceutical industry and of the businesses they will support.
- Candidates should have strong financial management experience.
- Key personal competencies for success include the ability to master both strategic and operational issues, strong technical aptitudes, ability to manage competing priorities, outstanding collaboration skills, and a positive “can-do” attitude.
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.
- 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).
- 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.
- The average travel for this position is 15% with some variation based upon the demands of the business imperatives.
The Research Associate I or II will be a key contributor to a scientific research team discovering drugs to treat diseases of aging. This is not a remote position but will require work in a laboratory with other personnel.
Responsibilities include performing experiments, data analysis, and presenting results at lab meetings. Studies will mostly focus on cell-based assays with human iPSC-derived cell types and cell lines. Also, some analyses of clinical samples may be performed, including proteomic analyses, graphing data, and performing statistical analyses. Designing experiments, executing them, and statistical analysis of data, presentation of data to company scientists and generation of data reports and study documentation is required.
Education & Experience:
- Bachelor’s degree in biology, neurobiology or equivalent experience required
- Some industry experience in drug discovery preferred (including internships) a plus
- Experience with assay development or performing cell-based assays preferred
- Technical expertise in methodologies such as immunocytochemistry, RNA purification, protein harvests, cell culture, performing cell-based experiments and other basic lab techniques preferred
- Ability to attend on-line video and teleconference meetings from home and access to Wifi necessary to do work from home required
- Good organizational, problem-solving and a team-player mentality required
- Proficiency in all MS Office products including excel, powerpoint, word; as well as graphing and statistical software programs (Prism)
- Demonstrated ability to work cooperatively in a fast-paced multidisciplinary team environment
- Position may be filled at a part-time or full-time status
The Research Scientist will be a key contributor to a scientific research team discovering drugs to treat diseases of aging. This individual will work from our offices in Pittsburgh, where their time will be shared between work in the laboratory and office. Ability to work in a fast-paced, dynamic environment is important.
This position will have responsibilities leading research studies internally and externally. Internally, this position will be involved in assessing the efficacy and mechanism of action of lead candidates, and assessing proof of concept (PoC). The research scientist will be expected to be capable of independently designing and executing in vitro cell-based studies, analyzing and interpreting data and will be expected to routinely present results to the research team to inform research & development decisions. Research scientist may also be involved in overseeing biomarker studies externally and performing biomarker and proteomics or RNAseq analyses. Externally, they will be responsible for the scientific study design and ensuring high-quality execution of work done externally. They will manage relationships with external vendors such as CROs as well as collaborations with academic and research organizations.
Education & Experience:
- Ph.D. in a relevant field (neuroscience, ocular disease, biology, pharmacology) or equivalent with 0-3 years of research experience (preferably in a biotech or pharmaceutical setting). A Masters in a relevant biological science with 5+ years of experience, or Bachelor’s in a relevant biological science with 5+ years of experience in a biotechnology or pharmaceutical company will also be considered.
- Evidence of scientific accomplishments in the form of publications and presentations preferred
- Demonstrated experience with cell-based assays, microscopy and/or high content imaging, and standard molecular biology techniques preferred
- Experience with biomarkers, proteomics, RNAseq, and bioinformatics a plus
- Experience running in vivo efficacy studies is recommended
- Experience generating high-quality data in a time-sensitive environment
- Experience with neurological and/or ocular disorders preferred
- Experience with lead identification/optimization using a combination of molecular, cellular and >in vitro/in vivo techniques a plus
Other Skills & Abilities:
- Excellent written and verbal communication skills; possessing the ability to describe research clearly and concisely to a cross-disciplinary audience
- Self-motivated and effective at managing multiple projects in parallel.
- Excellent organizational skills and attention to detail are required
- Intellectually curious, continuously driven to develop and improve scientific understanding and methodology
Relocation support may be considered
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.
- 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.
- 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.
- The average travel for this position is 20% with some variation based upon the demands of the business imperatives.