Senior Director, Drug Safety and Toxicology jobs in United States
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Eikon Therapeutics · 1 day ago

Senior Director, Drug Safety and Toxicology

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. The Senior Director of Drug Safety and Toxicology will lead the safety assessment function, providing technical and scientific leadership for safety studies and authoring regulatory documents throughout development.

BiotechnologyHealth CareLife ScienceMedical
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H1B Sponsor Likelynote
Hiring Manager
Tori Madonick
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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
Collaboration with chemistry and safety for determination of occupational exposure limits, permitted daily exposures, impurity assessments and generation of safety data sheets
Maintains 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
Individual should have a large network of external experts that can be utilized to troubleshoot and advise and be skilled at managing external relationships

Qualification

PhD in ToxicologyDrug safety expertiseRegulatory document preparationPharmaceutical drug discoveryFDA guidelinesOral communication skillsWritten communication skillsLeadership skillsCollaboration skills

Required

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

Benefits

401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site

Company

Eikon Therapeutics

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Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.

H1B Sponsorship

Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)

Funding

Current Stage
Late Stage
Total Funding
$1.12B
Key Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M

Leadership Team

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Roger Perlmutter
Chairman, President, and CEO
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Michael Klobuchar
Chief Operating Officer
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Company data provided by crunchbase