- Planning toxicology and safety pharmacology studies to bolster research and development projects
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- 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
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Sr. Director Toxicology - Bedford, United States - Delix Therapeutics
2 weeks ago
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:
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
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