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Form of workMind Medicine Inc. is looking for an Associate Director, Clinical Pharmacology, eager to contribute towards the development of Mind Med's key assets. The incumbent will report directly to the Director of Clinical Pharmacology. The ideal candidate will hold an advanced doctoral degree (eg, PhD, MD, PharmD) or Masters degree in pharmacokinetics or pharmacometrics discipline and have prior experience contributing to the development and execution of registration-level Clinical Pharmacology programs. Knowledge of population pharmacokinetic modelling is preferred, and experience in bioanalysis, ADME or PBPK is a significant plus. The position will serve as the Clinical Pharmacology representative on one or more clinical development teams to deliver high quality data for registration. The position requires the ability to partner with Clinical, Pharm Dev, 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 Clinical Pharmacology representative on global development teams
- Author phase 1 Clinical Pharmacology protocols, analysis plans and study reports
- Collaborate with or manage external consultants, as appropriate, to develop, execute, and report on model-based pharmacokinetic and exposure-response analyses to support clinical programs
- Contribute towards the writing of regulatory submission documents including INDs, IBs, NDAs, MAAs and pediatric plans, and participate in interactions with health authorities
- Develop high quality Clinical Pharmacology plans
- Present Clinical Pharmacology results and recommendations internally at relevant cross-functional sub teams
Requirements
- Doctoral degree (PhD, PharmD, MD or equivalent in relevant discipline) and 5+ years of clinical development experience, or Masters degree (in relevant discipline) and 6+ years of clinical development experience
- Working knowledge of pharmacokinetic and pharmacometrics software programs (e.g. WinNonlin, R, NONMEM, ADAPT, Monolix, Pumas etc.)
- Excellent written and oral communication skills, attention to detail and ability to convey complex technical information clearly
- Experience with data review and statistical analysis
- Possess general understanding of the overall clinical drug development process
- Proven ability to work independently and be self-motivated
- Strong time management skills and ability to prioritize multiple tasks efficiently
- Ability to function as a team player at a high level in a dynamic environment
- Experience in bioanalysis, ADME or PBPK is a plus
Other Skills
- Experience in CNS therapeutic area (Psychiatry or neurology) is a plus
- Experience in small molecule development and/or registration is a plus
Working Conditions and Travel
- This is a 100% remote position with ~10% travel requirement based on business needs
