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.
The Senior Director of Drug Safety and Toxicology will lead the safety assessment function at Eikon Therapeutics. This position will provide technical and scientific leadership to the strategy and execution of safety studies from late pre-clinical, IND enabling, through to registration. The individual will interface with internal discovery and clinical project teams as well as contract research organizations (CROs) for non-GLP and GLP work. In addition, this individual would be responsible for the authoring of regulatory documents throughout development and interactions with regulatory agencies.
You are a drug safety expert who has a deep understanding of safety assessment requirements across the stages of pre-clinical and clinical development and has experience in small molecules and biologics in multiple therapeutic areas including oncology, neuroscience, and inflammatory disease indications. You’re a hands-on leader who thrives in a fast-paced, dynamic environment. You’re well-organized, detail oriented, and take pride in your ability to rapidly analyze situations and make judicious decisions. You’re collaborative by nature with uncompromising integrity.
What You’ll Do
- Serve as toxicology expert to discovery and development teams.
- Expand and manage a group of toxicology scientists as companies 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, BLA, Annual Reports) as needed to support development programs, represent toxicology function in meetings with regulatory agencies.
- 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.
- 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, Australian 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 $248,000 to $285,000 depending on skills, competency, and the market demand for your expertise.