The Director/Senior Director of Toxicology will be accountable for nonclinical safety and report directly to the Vice President of Nonclinical Development & Clinical Pharmacology. This individual will collaborate with nonclinical pharmacokinetic and pharmacology scientists, external consultants, and CROs to drive the global nonclinical regulatory submission strategy for Arena Pharmaceutical’s research and development programs.
What you’ll dive into
- Conceptualize, develop, revise, and finalize nonclinical safety (GLP and non-GLP) study protocols, reports, and nonclinical sections for IND and NDA submissions, as well as required minor and major submissions to ensure regulatory compliance.
- Critically analyze and interpret nonclinical safety study data, review and edit external CRO nonclinical safety study reports, and coordinate report finalization with the help of external consultants and Arena nonclinical operations personnel.
- Provide critical input and review of nonclinical pharmacology and pharmacokinetic protocols, reports, and regulatory content.
- Ensure documentation consistent with global regulatory and compliance requirements.
- Manage and monitor nonclinical safety studies (GLP and non-GLP) conducted at external CROs per applicable vendor SOPs and ensure global regulatory/compliance requirements are met/exceeded.
- Provide analysis, interpretation, and visualization of nonclinical safety data in preparation for department, product leadership team (PLT), and other internal (Arena) and external communications.
- Leadership and participation on cross functional teams as nonclinical safety expert to ensure proper integration of these activities into overall project plans.
- Partner with and provide subject matter expertise to key internal constituencies (Clinical, Drug Safety, Regulatory, Quality, Technical Operations (CMC), Medical Affairs, etc.) and their external contractors or collaborators.
- Contribute to departmental processes such as SOP’s, operational support, templates, etc.
- Maintain a current understanding of regulatory guidance’s, relevant literature and methodologies, as well as the scientific literature related to specific Arena pipeline programs.
What we expect
- DVM or Ph.D. in Toxicology/Pharmacology or Biological Sciences required.
- 10 – 15 years of industry experience in conducting small molecule drug development.
- DABT certification strongly preferred.
- Familiarity with GLP regulations and ICH/FDA/EMA guidelines, and GLP regulations, for the conduct of nonclinical safety studies to support regulatory filings
- Experience selecting and working withCROs and external nonclinical safety consultants
- Required experience in authoring regulatory submissions, as well as multiple INDs and preparing detailed science-based responses to regulatory questions.
- Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical safety activities to set up drug candidates for success at all stages of development.
- Working knowledge of CMC and product quality, to enable impurity assessment and justification of specifications.
- Ability to multi-task and change quickly to changing priorities
- Strong written and oral communication skills and a track record of achievement in publications
- Ability to work collaboratively within cross-functional teams
- Demonstrated experience in nonclinical pharmacokinetic (ADME) evaluations, and PK/PD analysis/modeling, would be a plus.
What you’ll get
- To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
- Opportunities to learn and contribute creative solutions
- Comprehensive health insurance
- Matching 401k retirement plan
- Paid time off and holidays
- Company celebrations