Senior Director, Drug Safety and Toxicology at Eikon Therapeutics

Millbrae, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Drug DiscoveryIndustries

Requirements

PhD in Toxicology or related discipline and 12+ years post-graduate industry experience
Prior experience monitoring studies or acting as study director at CRO
Strong track record of pharmaceutical drug discovery experience, success and leadership, exemplified by advancement of programs through all stages of discovery and clinical development to IND filing and marketing application expertise
Demonstrated excellence in oral and written communication skills
In-depth knowledge of FDA, EMA, and ICH guidelines, including experience in the preparation of regulatory documents and knowledge of regulatory guidance
Deep understanding of safety assessment requirements across pre-clinical and clinical development stages
Experience in small molecules and biologics (a plus) in multiple therapeutic areas including oncology and non-oncology
Large network of external experts for troubleshooting and advising, with skills in managing external relationships

Responsibilities

Serve as toxicology expert to discovery and development teams
Expand and manage a group of toxicology scientists as company’s need evolves
Work cross-functionally with research teams to design exploratory and GLP compliant toxicology studies to investigate properties of candidate compounds
Design and implement regulatory toxicology studies at contract research labs, acting as study monitor, to support development of candidate and clinical stage molecules
Analyze and interpret data, determine next steps, and communicate results to development teams and management
Author regulatory submissions documents (IB, IND, Annual Reports) as needed to support development programs, represent toxicology function in meetings with regulatory agencies
Collaborate with chemistry and safety for determination of occupational exposure limits, permitted daily exposures, impurity assessments and generation of safety data sheets
Maintain currency with internal training and global regulatory requirements
Travel to CRO sites during study conduct to ensure regulatory compliance and effective execution of study protocols
Interface with internal discovery and clinical project teams as well as contract research organizations (CROs) for non-GLP and GLP work
Provide technical and scientific leadership to the strategy and execution of safety studies from late pre-clinical, IND enabling, through to registration

Skills

Toxicology

Drug Safety

GLP Studies

Pre-clinical Development

IND Enabling

Regulatory Documents

CRO Management

Small Molecules

Biologics

Oncology

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

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