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    Associate Director, Clinical Pharmacology - Durham, United States - Psychedelic Alpha

    Psychedelic Alpha
    Psychedelic Alpha Durham, United States

    Found in: Lensa US 4 C2 - 6 days ago

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    Description
    Mind 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

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