We're Hiring
Cognition Therapeutics is built on the tenets 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, we encourage you to submit your cover letter and CV to 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 head of clinical development & safety serves as the medical lead for Cognition Therapeutics’ CNS programs, working in collaboration with the chief medical officer to design proof-of-concept through registration-enabling clinical studies, as well as supporting clinical pharmacology and specialty physiology studies. As the scientific and medical lead, the head of clinical development & safety works closely with internal groups to plan, design, identify supporting resources, establish and manage budgets and timelines, and execute clinical development research studies to evaluate therapies for efficacy, safety, clinical pharmacology, and pharmacokinetics. The head of clinical development also has a significant externally facing role, building relationships with study sites, development partners, and the medical/scientific community. The position requires expertise in clinical development, with a strong understanding of the particular challenges of neurodegenerative disorders, as well as outstanding clinical and scientific knowledge applicable to clinical research. While extensive pharmacovigilance experience is not required, the head of clinical development & safety will assume leadership of Cognition’s drug safety program including cross study, study specific surveillance, and reporting to regulatory agencies.Key Responsibilities:
- Lead, design, and coordinate activities to support Phase 2/3 clinical programs in Alzheimer’s disease and dementia with Lewy Bodies.
- Develop unique and innovative clinical strategies to improve clinical development through faster studies and/or novel outcome measures.
- Partner with clinical operations and development operations to support all aspects of clinical trials including study concept, protocol development, site identification, investigator meetings, medical monitoring, safety, data review and interpretation.
- Serve as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, KOLs, advisory boards), internal stakeholders (e.g., R&D, clinical operations, development operations), and internal decision boards (senior management and Board of Directors).
- Lead the drug safety program, focusing on events, reporting and surveillance of patients in clinical studies and provide regular updates to DSMBs.
- Work with the R&D team to provide insight on next generation pipeline
- In conjunction with development operations and the communications team, 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; as appropriate, author scientific papers for journal publication.
- In conjunction with quality and regulatory affairs 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
Qualifications:
Education & Experience- MD or DO (or equivalent) with direct experience with CNS-related disorders
- 10+ years of industry drug development experience, ideally from pre-clinical through Phase III (or beyond) stages; NDA experience is a plus; strong academic background may substitute for some industry experience.
- Industry experience to include responsibility as a senior director or medical director for designing, leading, and managing clinical studies
- Strong understanding of the drug development process evidenced by the ability to execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
- Strong knowledge of Good Clinical Practices, FDA regulations and guidelines, and related regulatory requirements.
- Demonstrated ability to interact skillfully with investigators, site coordinators, collaborators, CROs, foundations and institutes, other biotech/pharma companies, granting agencies, partners and regulatory agencies.
- Ability to work with multi-functional and multi-disciplinary teams in a fast-paced environment in which priorities may change rapidly.
- Demonstrated ability to proactively identify challenges and quickly and creatively propose solutions.
- Excellent writing and presentation skills with ability to communicate scientific concepts to internal and external stakeholders with varying levels of medical expertise.
- Onsite presence in Purchase, NY offices on a mutually agreed-upon schedule, such as 1-2 days per week every other week
- Travel up to 10% (largely domestic, some international) to clinical study sites and relevant medical/scientific meetings and congresses
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VISION
We drive the industry towards a cure for neurodegenerative disease by conquering the hurdles to the development of restorative therapies.
We are the beginning of the end of neurological disorders and the start of hope for an improved future for our patients.
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VALUES
Purpose: We make a meaningful difference in the lives of our patients, partners and team members.
Inclusivity: We involve others in problem solving and decision making, efficiently leveraging the diverse capabilities of others.
Drive: We are resourceful and persistent in our desire to change human health by mitigating disease.
Transparency: We readily offer knowledge and support to colleagues; we want everyone to succeed.
Balance: We balance a bias toward achievement with a genuine interest in the lives of those with whom we work.
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Employee Value Proposition
We design breakthrough therapies for people with neurodegenerative conditions.
We are a highly collaborative and synergistic team of professionals.
We thrive in an honest, respectful, and open workplace into which all team members are invited, heard, and appreciated.
We value personal responsibility and accountability, and seek to recognize and reward courageous, innovative contributions.