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Job Description
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 [commensurate with experience], 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 assessment parameters
- Work with ExploR&D regulatory personnel to ensure compliance
- Serve as Sponsor physician for case-management of SAEs, or provide oversight to outsourced function
- Network with Lilly Global Product Safety and clinical development counterparts from other therapeutic areas, either internally to Lilly or external, to ensure appropriate risk management
- Author or review and approve key sections of Investigator Brochures including development core safety information, reference safety information and Safety and Efficacy summaries.
- Conduct dose-escalation data reviews and trial level safety reviews
- With a good grasp of pharmacology, work closely with PK/PD, toxicology and ADME functional leads and, as part of the multidisciplinary team, to support dose selection, PK/biomarker strategy across early development phases
- Comply with local laws and regulations, and global policies and procedures with respect to data dissemination and interactions with external health care professionals.
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on an international basis. Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Participate in development of scientific data dissemination, and preparation of final reports and publications.
Medical Leadership
- Share learning within ExploR&D and feed learning back to Lilly teams in order to effectively enhance and grow internal capabilities and productivity.
- Work closely with ExploR&D colleagues to continue to evolve ExploR&D standards, tools, and best practices across clinical development, bringing forward new and innovative ideas and processes
Basic Qualifications
- Medical Doctor. Must be certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training in China; **with at least **5 years of direct experience in the pharmaceutical industry
- Preference for trained physicians who have achieved certification and/or have clinical practice experience at the attending level
Additional Preferences
- Strong clinical pharmacology and/or translational biology experience with a Masters or PhD background as a plus.
- Extensive early phase clinical trial experience, with at least 5-7 years in industry (or equivalent experience, eg work as an investigator), and experience in authoring and executing multiple Phase 1 and 2a protocols, ideally across a range of therapeutic areas. Experience and deep understanding of GCP and the management of medical safety in the context of clinical trials (either the investigator or sponsor side)
- Strong computer skills; Word, Excel, PowerPoint, Teams and SharePoint
Other Information
- Hybrid role based in Boston, MA or Indianapolis, IN (Remote considered for exceptional candidates)
- 25% travel may be required
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