Uniquely positioned to enhance quality of life in aging, we are pioneering science that is rapidly being translated to the clinic. Our approaches utilize molecular, proteomic and behavioral techniques to identify therapeutics and apply them to patients.
As a pivotal member of Alkahest’s growing Clinical Team, you will be responsible for a wide variety of traditional and non-traditional CPM activities. From the management of Phase I-V clinical research projects, clinical vendor oversight, development of clinical SOPs, regulatory support and even tactical plan development and execution, this is a unique opportunity to totally emerge yourself in the drug development process at an exciting, innovative, and financially secure startup. Your primary responsibilities will be to provide exceptional vendor oversight of all aspects of study management in a largely outsourced clinical model, ensuring compliance with GGPs and protocol requirements. You will also have the opportunity to be involved in regulatory, training, compliance and/or more as your skills and interest dictate. This is truly a once in a lifetime chance for a high performing team player to make a difference in the health and vitality of humankind through the development of transformative therapies that counterbalance the aging process.
Specific responsibilities include, but are not limited to:
• Manage the start-up, ongoing activities, close-out and reporting of specific research projects
• Coordinate the development of research protocols, investigator’s manuals, informed consents, case report forms and budgets related to each project
• Responsible for development and management of SOPs, Clinical Oversight Plans, and training plans that lay the foundation of corporate GCP compliance
• Ensure that clinical research monitors visit the research sites and that all reports, edits and issues are correctly brought to a close
• Responsible for ensuring that clinical research material is available, distributed, used and monitored correctly
• Ensure the development of CRFs and related plans for the appropriate management and analysis of the data collected
• Assist in the writing of INDs, IND Updates, NDAs, safety reports, status reports and final clinical study reports
• BS in Life Sciences
• Minimum 5 years clinical experience in a pharmaceutical, biotech, or medical device company, or academia, including 3-4 years as a Clinical Research Associate or Clinical Research Coordinator
• Knowledge of multiple aspects of the clinical research discipline and GCPs is essential.
• Strong communication and interpersonal skills
Please note: Resumes without Cover Letters will not be accepted. Thank you.