Associate Director, Bioanalysis

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as an Associate Director, Bioanalysis. Reporting to the Senior Director of Clinical Pharmacology, you will be responsible for overseeing bioanalysis for clinical and non-clinical studies. This role requires a PhD or Master's degree in a relevant field and 7+ years of experience in regulated bioanalysis. You will collaborate with various departments and CROs to ensure high-quality data delivery. The position involves designing and executing bioanalytical studies, reviewing data, authoring regulatory reports, and contributing to IND/NDA filings. MindMed offers competitive benefits, including 100% paid health benefits, a 401(k) program, flexible time off, and generous parental leave.

Requirements

• Doctoral degree or Master’s degree and 7+ years of relevant experience in regulated bioanalysis
• Knowledge of chromatographic separation, gas phase ionization, and mass spectrometry and experience in biomatrix sample clean-up and LC-MS/MS for bioanalysis
• Ability to develop and validate bioanalytical methods
• Ability to design and execute stability studies in a variety of biomatrices
• Experience in identifying and selecting high quality CROs for the conduct of non-clinical and clinical bioanalytical work
• Ability to conduct site inspection/audit and supervise outsourced studies
• Experience in reviewing and interpreting bioanalytical data/reports from non-clinical studies and clinical trials
• Ability to effectively communicate with multiple departments within the organization as well as CROs
• Travel will be required of this position and is anticipated at a maximum of 15%

Responsibilities

• Serve as the Bioanalysis representative on global development teams
• Design and oversee the execution of bioanalytical method development and validation studies using LC-MS/MS with minimal guidance and supervision
• Manage bioanalytical projects as well as communicate with Non-Clinical and Clinical departments and CROs to ensure high quality bioanalytical data/reports are delivered in accordance with project timelines
• Provide expert review of clinical and non-clinical data generated from regulated bioanalytical assays
• Author relevant regulatory reports and briefing documents summarizing bioanalytical methods and results
• Be knowledgeable of current regulatory landscape as it relates to bioanalytical methods

Preferred Qualifications

Experience in preparation of summary sections for regulatory (IND/NDA) filings is a plus

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave
• Bonus and equity