At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary: We are seeking an experienced toxicology leader for our Advanced Molecule Design (AMD) group. The Senior Director, Discovery Toxicology will be responsible for guiding early stage through advanced drug discovery programs through all stages of toxicology assessments from early discovery to IND. The AMD team executes projects across the breadth of cancer biology and delivers medicines across drug modalities, including small molecules, degraders, ADC's, and radioligand therapies. This role demands a blend of deep scientific expertise, strong people leadership, and a synergistic collaborative style to ensure the identification, evaluation, and mitigation of toxicological risks across the oncology portfolio.
Responsibilities: Toxicology Strategy and Execution Conduct in-depth literature reviews to understand potential toxicological liabilities of targets and modalities to inform overall portfolio strategy.Lead the team to design and oversee toxicology studies (in vitro and in vivo) to assess on-target and off-target toxicities, from early discovery to IND filing.Utilize mechanistic assays (e.g., CEREP panel, hERG) and in silico methods (e.g., DEREK) for early identification of risk for chemical leads series. Implement screening cascades that allow for optimization to mitigate tox risks.Lead the discussion on clinical risk vs benefit from a toxicology point of view.Lead the discussion on portfolio level strategy for new targets and modalities.Lead the team in developing and maintaining strong relationships with toxicology CRO's worldwide. Work to expand our network of quality providers to enhance our ability to execute on competitive timelines.Team Leadership and Development Lead the oncology tox team in their day-to-day execution of toxicology projects.Assign projects based on individual strengths and experiences.Foster a collaborative environment, facilitating meetings to troubleshoot and plan across projects.Mentor the toxicology team for professional and career growth.Cross-Functional Collaboration Work closely with discovery leaders and teams (e.g., DMPK, Chemistry, CMC, Pharmacology, PBPK modeling) to advise on and coordinate toxicology strategy, plans, study designs, and timeline.Be willing to engage leaders from outside the tox domain on obstacles and opportunities to deliver better results faster.Engage with broader teams across the organization, Subject matter experts and safety advisory committees to glean mechanistic understand of toxicology readouts and use that understanding to predict likelihood and severity of clinical AE risk.Work with clinicians and the development team to assess the risk benefit analysis and monitoring strategies.Communication and Reporting Lead the team to present transparent, organized and contextualized toxicology findings, assessments and plans forward in working core meetings, project teams and leadership strategy discussions.Develop and use effective presentation methods to put tox findings in context of efficacy exposure, predicted anti-targets and benchmark molecules.Guide the team to write clear and concise IND reports. Maintains excellence in recordkeeping and documentation to support regulatory filings.Innovation and Improvement Identify areas for technological advancements and process improvements within the toxicology domain to further our ability to obtain accurate assessment of toxically risk.Champion processes that allow the organization to speed the delivery of quality medicines to patients. Identify time sinks and bottlenecks and actively propose processes to resolve them.A highly engaged, positive, can-do mindset is a requirement for this position.Basic Requirements: Advanced degree (PhD, MD, MSc) in Toxicology or related discipline required.10+ years of deep experience in Toxicology work within the Pharmaceutical and/or biotech industry.Proven track record of success in leading toxicology assessments from early discovery through to IND submission.Deep understanding of toxicology regulatory requirements for IND-enabling studies.Strong leadership skills with experience in team development and mentorship.Excellent collaboration and communication skills, with the ability to work effectively across diverse teams.Drive to overcome challenges.Strong desire to provide impactful drugs to patients living with cancer.Additional Preferences: Drive to overcome challenges.Strong desire to provide impactful drugs to patients living with cancer.
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