Eikon Therapeutics
Associate Director, Toxicology
Eikon Therapeutics, Hayward, California, us, 94557
Position
As an Associate Director of Toxicology, you will play a pivotal role in shaping and driving the non-clinical safety profile of therapeutics to support clinical testing. Your leadership will contribute to the advancement of our understanding of preclinical drug candidates and their potential safety impact.
About You
Reporting to the Senior Director, Head of Toxicology, the ideal candidate for this position should have extensive toxicology experience and a deep understanding of safety assessment requirements across the stages of pre-clinical and clinical development. Experience in small molecules in multiple therapeutic areas, with preference for oncology, neuroscience, and inflammatory disease indications, is preferred. Exceptional attention to detail and outstanding organizational skills, along with the ability to lead and collaborate effectively within cross-functional teams, are crucial for this role. Strong communication skills are necessary for clear interactions with team members, stakeholders, and for presenting scientific findings.
What You’ll Do
Serve as toxicology expert to discovery and development teams.
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, BLA, Annual Reports) as needed to support development programs, represent toxicology function in meetings with regulatory agencies.
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.
Qualifications
PhD in Toxicology, Pharmacology, or a related field with 8+ years of relevant experience.
Prior experience monitoring studies or acting as study director at CRO.
Strong track record of pharmaceutical drug discovery and development experience, success, and leadership, exemplified by advancement of programs to IND filing. Marketing application expertise a plus.
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.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
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
The expected salary range for this role is $174,000 to $190,000 depending on skills, competency, and the market demand for your expertise.
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As an Associate Director of Toxicology, you will play a pivotal role in shaping and driving the non-clinical safety profile of therapeutics to support clinical testing. Your leadership will contribute to the advancement of our understanding of preclinical drug candidates and their potential safety impact.
About You
Reporting to the Senior Director, Head of Toxicology, the ideal candidate for this position should have extensive toxicology experience and a deep understanding of safety assessment requirements across the stages of pre-clinical and clinical development. Experience in small molecules in multiple therapeutic areas, with preference for oncology, neuroscience, and inflammatory disease indications, is preferred. Exceptional attention to detail and outstanding organizational skills, along with the ability to lead and collaborate effectively within cross-functional teams, are crucial for this role. Strong communication skills are necessary for clear interactions with team members, stakeholders, and for presenting scientific findings.
What You’ll Do
Serve as toxicology expert to discovery and development teams.
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, BLA, Annual Reports) as needed to support development programs, represent toxicology function in meetings with regulatory agencies.
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.
Qualifications
PhD in Toxicology, Pharmacology, or a related field with 8+ years of relevant experience.
Prior experience monitoring studies or acting as study director at CRO.
Strong track record of pharmaceutical drug discovery and development experience, success, and leadership, exemplified by advancement of programs to IND filing. Marketing application expertise a plus.
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.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
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
The expected salary range for this role is $174,000 to $190,000 depending on skills, competency, and the market demand for your expertise.
#J-18808-Ljbffr