Associate Director, Non Clinical Safety Evaluation
About The Position
The primary responsibilities of an Associate Director in the Nonclinical Safety Evaluation (NSE) organization are to (1) design and implement nonclinical safety assessment strategies to support the nomination and development of Alkermes’ diverse small molecule drug candidates and (2) communicate strategies and findings internally and to regulatory authorities globally. The Associate Director is the single point of accountability within NSE for all strategic, scientific, study-related, and regulatory aspects of the programs he/she manages. The Associate Director in NSE has a broad understanding of toxicology and regulatory requirements to progress candidates through clinical development and is recognized by internal peers for his/her scientific contributions and deliverables (within discipline) to Discovery and Development programs. The individual has specific expertise in one or more areas relevant to nonclinical safety evaluation, shows competency in all aspects, and requires limited supervision on scientific/technical elements of the role. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week.
Requirements
- PhD in Toxicology or related discipline with 8+ years of experience in the conduct and submission of nonclinical safety evaluation studies in the biotech/pharmaceutical industries; other advanced professional degrees with 8+ years of relevant experience, MS with 15+ years of relevant experience, or BS with 20+ years of relevant experience
Nice To Haves
- Board certification in toxicology desirable if formal training is not in toxicology
- Strong understanding of GLPs
- Experience as a Study Director and/or managing studies at CROs
- Experience as a nonclinical safety representative on Discovery and/or Development teams
- Broad understanding of nonclinical safety evaluation and drug development
- Strong communication skills to effectively interact with Alkermes’ colleagues across all levels, including senior management
- Small molecule experience desirable
- Specific experience in Discovery Toxicology project strategy desirable (including experience in designing effective toxicology plans to identify hazards and to characterize and address risk of toxicity for compounds moving into Development).
Responsibilities
- Provide nonclinical leadership as a core member to multidisciplinary Discovery and Development Project Teams, which lead candidates through nomination and registration milestones, respectively
- Design mechanistic and Discovery toxicology studies supporting lead optimization and nomination-enabling stage programs
- Design nonclinical safety pharmacology, abuse potential, genetic toxicology, general toxicology, developmental and reproductive toxicology, carcinogenicity, and/or investigative studies for Alkermes’ Development candidates
- Accountability for and scientific oversight of nonclinical safety evaluation studies at CROs within and outside the U.S.
- Serve as Study Director for internal investigative and range-finding toxicology studies
- Draft nonclinical contributions to U.S./global regulatory submissions and participate in interactions with regulatory authorities
- Stay up to date with the latest advancements in toxicology and integrate new methodologies into research practices
- Identify safety-related knowledge gaps and propose risk-mitigation plans
- Interface with Alkermes' senior management on nonclinical development plans, risk assessments, and issue resolution
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
1,001-5,000 employees
