Associate Director, Bioanalysis

Mind Medicine Inc. is looking for an Associate Director, Bioanalysis, eager to contribute towards the development of Mind Med's key assets. The incumbent will report directly to the Senior Director of Clinical Pharmacology. The ideal candidate will hold a PhD or Master's degree in relevant discipline and have prior experience overseeing regulated bioanalysis for clinical and non-clinical studies. Prior regulatory experience, including contributions to biopharmaceutics modules is a significant plus. The position will serve as the bioanalysis representative on early phase and late phase clinical development teams to deliver high quality data for registration. The position requires the ability to partner with Clinical, Non-Clinical, Pharmaceutical Development, Clinical Operations, and Regulatory Affairs as well as other internal stakeholders to deliver high quality clinical programs for registration and launch.

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

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%

Other Skills

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

The starting base pay range for this position is $162,193.00 - $190,000.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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 and some fun fringe perks!