Associate Director, Toxicology

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Job description

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. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

As an Associate Director of Toxicology, you will play a pivotal role in shaping and driving 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 and has experience in small molecules in multiple therapeutic areas, with preference for oncology, neuroscience, and inflammatory disease indications. 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.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

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