Job Description
**Job Title:** Executive Director, Toxicology
**Location:** United States
**Job Type:** Full-time, Remote
**Seniority Level:** Director
**Position Summary:**
As the Executive Director of Toxicology, you will bring your expertise in toxicology to develop and execute non-clinical safety assessment strategies. Your role will be crucial in de-risking and advancing research and development stage programs. Additionally, you will offer broader non-clinical development expertise in nonclinical pharmacology and ADME/PK, fostering close coordination and integration across all nonclinical disciplines. You will report to the Executive Vice President and Chief Medical Officer.
**Primary Responsibilities:**
- Collaborate with Translational Research and Clinical Pharmacology to lead and drive the formulation and execution of toxicology, pharmacology, and ADME/PK strategies and plans for programs in discovery and development phases.
- Serve as a key expert for nonclinical safety assessment, providing specific knowledge and expertise to cross-functional project teams to navigate compound safety risks through various stages of drug discovery and development.
- Design, operationalize, and interpret nonclinical studies to evaluate candidate molecule toxicities, therapeutic index, and overall risk/benefit assessment.
- Identify and manage high-quality CROs to conduct toxicology studies and reporting, ensuring they meet program timelines.
- Foster significant cross-functional interactions and collaboration between Toxicology, Translational Research, Clinical Pharmacology, Clinical, Pharmacovigilance/Drug Safety, Regulatory, and CMC functions.
- Stay up-to-date with regulatory agency regulations and guidelines related to nonclinical development.
- Maintain a command of relevant scientific literature and evaluate implications for internal projects.
- Serve as a nonclinical subject matter expert to interact with global regulatory authorities.
- Contribute as an author of preclinical safety/toxicology reports and summaries and reviewer of nonclinical pharmacology and ADME/PK summaries for regulatory submissions and clinical documents to ensure appropriate integration of findings across nonclinical studies.
- Perform other responsibilities and duties as required.
**Competencies:**
- Broad nonclinical subject matter expertise in toxicology, pharmacology, and ADME/PK.
- Ability to operate effectively in a matrixed environment.
- Strong knowledge of GLP regulations and ICH regulatory guidance relevant to nonclinical Toxicology/DMPK/Pharmacology activities.
- Excellent written and oral communication skills.
- Ability to collaborate effectively both within and across internal and external teams.
- Must be hands-on, self-motivated, proactive, work well under pressure and deadlines, and thrive in a high-performing team environment.
**Experience:**
- PhD, DVM, or equivalent degree from an accredited institution in Toxicology, Pharmacology, or a related science.
- 10+ years of relevant nonclinical development experience in the pharmaceutical/biotechnology industry, reflecting a broad range of therapeutic modalities, including small molecule and oligonucleotide drugs.
- DABT certification preferred.
- Oncology background preferred.
- Demonstrated small molecule drug discovery experience, including a track record of advancing novel therapeutic agents from discovery into preclinical and subsequent clinical development as a project team leader or member.
- Significant experience authoring nonclinical sections of INDs/CTAs, NDAs/MAAs, IND Annual Reports/DSURs, Briefing Books, Investigator Brochures, clinical trial protocols, etc.
- Experience interacting with global regulatory authorities.
- Extensive experience in designing, executing, and interpreting IND and NDA-enabling nonclinical studies, including carcinogenicity studies.
- Demonstrated experience leading multi-disciplinary drug discovery and preclinical stage teams.
- Strong, demonstrable track record of scientific leadership excellence.
**Benefits:**
- Comprehensive benefit program including medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan.
- Generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events.
**Salary:**
- General Salary Range: $300,000 to $325,000
Employment Type: Full-Time
Salary: $ 300,000.00 325,000.00 Per Year
Job Tags
Holiday work, Full time, Remote job, Flexible hours,