Location: South San Francisco, CA
The Medical Director will support our clinical development programs at different phases; we have multiple clinical-phase molecules and many target indications; we have studies on multiple continents. The successful candidate will demonstrate the flexibility and capability to function at a high level. The Medical Director will interact with multiple internal stakeholders (Clinical Operations, Regulatory, Statistics, Data Management, Drug Safety, preclinical R&D) within Cortexyme and external stakeholders in the medical community. The Medical Director will be fully engaged in the development of clinical trial designs, execution, data reviews and interpretation, as well as development of clinical study reports and other regulatory and commercial documents with a cross-functional team.
- Lead the clinical development sub-team(s) responsible for medical/scientific aspects of conceptualizing and planning clinical trials and ensuring cross-functional integration, co-ordination and alignment to enable effective and efficient formulation of study designs and clinical study protocols.
- Conduct medical monitoring of clinical trials, review informed consent documents.
- Medically and scientifically accountable for ensuring patient safety (e.g., AE’s & SAE’s, labs, imaging), PI selection & interaction, and scientific documents reporting safety monitoring.
- Respond to questions from regulatory agencies, institutional review boards and ethics committees; review clinical data, case report forms and ensure final accuracy of clinical trial data for clinical study reports.
- Work collaboratively with regulatory and other functions to deliver the clinical research components in the preparation/review of regulatory documents, IND annual reports, IND safety reports, and investigator brochures.
- Ensure adherence to regulatory requirements of study conduct and industry standards of ICH/GCP and internal and vendor SOPs.
- Interact with and coordinate appropriate scientific and medical activities with internal stakeholders (e.g., clinical operations, statistics).
- Participate in review of medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
- Serve as part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections, as applicable.
- As appropriate, assist in the clinical evaluation of business development opportunities and provide clinical assessments of relevant drug discovery projects.
- Ensure budgets, timelines, compliance requirements are factored into programs’ scientific activities.
- Work on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors.
- MD or equivalent; residency or additional post doctorate experience is preferred
- 3-7 years’ experience in the pharmaceutical industry or equivalent
- Alzheimer’s Disease and related CNS disorders, periodontal disease experience a plus
- Understanding of ICH/GCP guidelines, FDA and EMEA regulations
- Proven leadership skills at program level and in a cross-functional team environment, international experience is a plus
- Ability to run one or more clinical trials with little supervision
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in drug development strategy and protocols
- Understanding of the pharmacovigilance practices for clinical development programs
- Excellent scientific written and oral communication skills
- Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality
- Exercise judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions and address problems
- Ability to travel up to 25%
Cortexyme is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, disability status or any other characteristic protected by law.
For more information on Cortexyme, visit www.cortexyme.com.