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    Sr. Director Toxicology - Bedford, United States - Delix Therapeutics

    Delix Therapeutics
    Delix Therapeutics Bedford, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    The Company

    Delix Therapeutics is a cutting-edge neuroscience company dedicated to leveraging the potential of psychoplastogens—a new class of therapeutics that promote neuroplasticity—to address brain health conditions. Based in Massachusetts, Delix is on a mission to develop FDA-approved medications that cater to the pressing needs of patients. By assembling a seasoned team and implementing innovative strategies, Delix aims to tackle the increasingly prevalent challenges in brain health.

    The Position

    Delix Therapeutics is in search of a skilled toxicologist to oversee the toxicology department within our expanding R&D division.

    As the Senior Director of Toxicology, reporting to the Chief Scientific Officer, you will play a pivotal role in designing and supervising safety assessment programs for CNS drug candidates. Your responsibilities will encompass strategic guidance across all toxicology aspects, including formulating study protocols and reports, as well as analyzing data from various research endeavors. Additionally, you will be tasked with drafting nonclinical segments of regulatory documents and engaging with regulatory bodies.

    Responsibilities:

    The role will necessitate a hybrid presence at our Bedford, MA location. Alongside the aforementioned duties, responsibilities may entail:

    • Planning toxicology and safety pharmacology studies to bolster research and development projects
    • Acting as a study overseer: assessing study protocols, participating in regular CRO meetings to ensure study integrity, meticulously reviewing study reports, and interpreting data
    • Compiling nonclinical portions of regulatory documents and liaising with regulatory authorities when required
    • Collaborating with various departments such as clinical pharmacology, regulatory affairs, clinical development, CMC, among others

    Qualifications:

    Hold a PhD in toxicology or a related discipline

    Prior experience in outsourcing and monitoring studies externally is essential

    Proficiency in DMPK is a prerequisite

    Board Certification in Toxicology is advantageous

    More than 8 years of pertinent industry experience in pharmaceutical R&D involving small molecules; specific experience in CNS drug advancement is vital

    Familiarity with ICH, EU, and FDA guidelines for nonclinical drug progression

    Must have IND exposure, NDA familiarity is beneficial

    • Act as the company's expert for in-licensing/out-licensing endeavors
    • Demonstrate strong organizational abilities and adeptness in handling multiple tasks
    • Possess excellent written and verbal communication skills

    Delix upholds a diverse and inclusive work environment, being an equal opportunity employer.

    Recruitment and Staffing Agencies: Delix Therapeutics refrains from accepting unsolicited resumes from any parties other than candidates directly. Submission of unsolicited resumes by recruitment or staffing entities to Delix or its employees is strictly prohibited unless contacted directly by Delix's Talent Acquisition Team



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