Job Description
Job Title: Executive Director, Toxicology
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Director
Position Summary
The Executive Director, Toxicology will provide toxicology expertise to develop and execute non-clinical safety assessment strategies and help to derisk and advance research and development stage programs. The Executive Director will also provide broader non-clinical development expertise in the areas of nonclinical pharmacology and ADME/PK to foster close coordination and integration across all nonclinical disciplines. The Executive Director, Toxicology will report to the Executive Vice President Chief Medical Officer.
This position is remote with a corporate headquarters in Foster City, CA Parsippany, NJ.
Primary Responsibilities - Collaborate with Translational Research and Clinical Pharmacology in leading and driving formulation and execution of toxicology, pharmacology, and ADME/PK strategy and plans for programs in discovery and development phases
- Act as key expert for nonclinical safety assessment of the Company’s programs 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
- Successfully identify and manage high quality CROs in the conduct of toxicology study execution and reporting to meet program timelines
- Foster significant cross-functional interactions and collaboration between Toxicology, Translational Research, Clinical Pharmacology, Clinical, Pharmacovigilance/Drug Safety, Regulatory, and CMC functions
- Maintain up to date knowledge of 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 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
- 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 track record of advancing novel therapeutic agents from discovery into preclinical and subsequent clinical development as 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 design, execution, and interpretation of 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
Benefit Statement:
All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include 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. Geron also provides regular-status, full-time employees with a 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. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron’s intention to comply with all applicable federal, state, and local laws that apply to the Company’s employees.
Salary Statement:
Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background. The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations.
General Salary Range: $300,000 to $325,000
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Job Tags
Holiday work, Full time, Contract work, Local area, Remote job, Flexible hours,