ExploR&D Translational Medicine

ExploR&D Translational Medicine Director

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.

Organizational Overview:

ExploR&D, a Division of Lilly Research Laboratories, is a drug development organization with a mission to catalyze the biotechnology ecosystem. As a multidisciplinary team of highly experienced drug developers, we seek to advance investigational medicines for external sponsors with speed and efficiency. ExploR&D (operating as Chorus since 2002) has supported over 90 development programs throughout North America, Europe, and Asia. We are therapeutic area and modality agnostic, and seek to advance breakthrough science and create value for our partners and patients.

Purpose of the Role:

The Director, ExploR&D Translational Medicine incumbent is responsible for the overarching medical strategy and medical oversight for multiple assets in the ExploR&D portfolio, across therapeutic areas and modalities. This unique breadth and depth of the role gives the right candidate the opportunity to provide leadership in early phase clinical development on multiple exciting programs, working with external biotechnology companies and venture capital funds, as well as internal Lilly therapeutic area experts.

Core Job Tasks:

• For assigned assets, the incumbent is accountable for the medical and safety leadership for all phases of drug development from candidate selection to proof-of-concept readout.
• Works with a multidisciplinary team to construct and execute a sound clinical development plan to develop and test key scientific hypotheses, discharge risks regarding asset safety and efficacy, and enable effective decision-making related to asset development.
• Partner with the project team leader who holds accountability for the scientific strategy and overall program management, and other cross functional experts to develop, consult on, and/or execute development plans.
• Works with toxicology and pharmacokinetics teams, especially for First-in-Human (FIH) assets, in establish starting doses, dose ranges and in interpreting emerging human PK/PD data to inform dose escalation and dose regimen selection for proof-of-concept studies.
• Author, review and approve key documents, including protocols, risk profiles, informed consent documents, clinical study reports, and disclosure of research results.
• Interface directly with client companies, including biotechnology startups and venture capital product companies.

Core

Job Responsibilities:

• Integrate complex scientific concepts quickly (critically reviewing and evaluating available information on asset and disease biology) and applying this effectively to development programs
• Critically read and evaluate the relevant medical and scientific literature; know the status and data from relevant competitive assets and keep updated with medical, safety and other scientific developments relevant to the ExploR&D asset
• Network with internal Lilly experts and external thought leaders to maintain awareness of current trends and projections for clinical research, practice, and access in the therapeutic area(s) relevant to the product
• Provide medical leadership for clinical plans including appropriate strategic objectives, study population, dose range justification, biomarkers and study endpoints, assessment of safety, drug-drug interactions, and critical success factors
• Provide scientific content to critical documents with primary accountability for risk/benefit assessment, patient safety and observing the principles of GCP
• Review and assist in the preparation of regulatory documents (IND, CTA, IMPD, IB, DSURs, etc.) and responses to regulatory questions
• Author relevant protocol sections, and review and approve protocols
• Contribute to informed consent documents, clinical study reports, publications, and other disclosures of research results.

Clinical Study Execution:

• Provide medical leadership in early development study conduct including study design, safety management plans, protocol writing, regulatory documents, CRO interactions, study start up, investigator interactions, data monitoring, health authority interactions, analyses, and study reports
• Lead dose-escalation meetings and trial-level safety reviews; serve on safety review teams
• Manage safety for assigned clinical stage ExploR&D compounds and clinical trials, serving as medical monitor; escalate issues as appropriate
• Work with the team to develop medical monitoring plans, safety management plans, monitoring and alert plans for key laboratory or other safety…