Company Description
Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX) startup company translating scientific findings from MIT into therapeutic approaches for Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our phase 2 data that showed preservation of both brain function and structure in Alzheimer's patients. Cognito initiated our pivotal study for first-line treatment of Alzheimer’s in Dec 2022 and expects to start additional clinical studies in Mild Cognitive Impairment (MCI) and Parkinson’s Disease in 2023. We are a fast-moving, highly motivated team of people with the ambitious goal of helping millions of patients and caregivers around the world who are burdened with neurodegenerative conditions. With our patented gamma stimulation technology, we are committed to developing non-invasive device-based therapies.
About the Job
Cognito Therapeutics, Inc., is seeking an experienced Project Manager to join our growing Program Management team tasked with driving large cross-functional projects and programs forward. In collaboration with the Program Management team, this individual will be responsible for project definition, resourcing, planning, and execution to timelines. This individual will work together with the cross-functional project teams to identify project risks, set goals and milestones, and ensure project completion on-time and within budget by maintaining focus on the critical path. They will be responsible for reviewing and reporting the status of the project with the team and to the Program Management team. We are looking to add a versatile, collaborative, and driven individual to our team.
Roles and Responsibilities
- Manages complex cross-functional design and development projects on a first in class wearable device for the treatment of Alzheimer’s disease and other neurodegenerative diseases.
- Formulates and gains approval for project plans in consultation with program managers, and stakeholders; develops and sets interim goals and milestones to ensure overall project success.
- Works with cross-functional team (Engineering, Manufacturing Operations, Product, etc.) to ensure timely and complete deliverable execution (e.g., design control execution).
- Collaborates with Quality and Regulatory to ensure the project is fully compliant with the Quality System, FDA design controls, and global regulatory agency requirements.
- Partners with development team members to drive accountability of project tasks and deliverables.
- Develop and manage project resource plan and manages project budgets, generates forecasts, and tracks actuals against forecasts.
- Identifies, analyzes, and tracks project risks and issues and monitors progress to plan and implements corrective actions or contingencies as needed to maintain commitments.
Qualifications
- BS in engineering or technical field, or equivalent practical experience
- 7+ years of experience leading and executing the coordination of projects in the medical device or pharmaceutical industry (at least 3+ years in medical device), resulting in the delivery of products.
- Experience with medical device development and design control is required.
- Product development experience from concept development through commercialization.
- Demonstrated understanding of FDA Quality System Regulation (21 CFR 820), ISO 13485, and EU Medical Device Regulation.
- Excellent communication and project management skills with a track record of successfully delivering projects on time.
- Experience meeting multiple project schedules on time.
- Strong verbal and written communication, analytical and problem solving, negotiation, and interpersonal skills.
- Experience working with products incorporating hardware, firmware, and software is preferred.
- Proficiency with project management and budgeting tools.
