Lilly Clinical Research Physician/Medical Advisor-Chorus in Indianapolis, Indiana
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 35,000 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.
Chorus, a Division of Lilly Research Laboratories, is a virtual clinical development organization that specializes in efficient proof-of-concept studies. We seek to advance a portfolio of New Molecular Entities to key value inflection points with speed and cost-effectiveness. Assets within the Chorus portfolio originate both internally from the Lilly pipeline as well as externally, working with biotech sponsors. Chorus collaborates with internal stakeholders to refine strategy to maximize pipeline impact, and with a network of external partners to execute and deliver experiments from IND enabling through to clinical proof of concept.
Since its creation in 2002, Chorus has supported over 80 asset development programs (a mix of Lilly-sponsored and non-Lilly sponsored programs) throughout North America, Europe, and Asia, including assets that have progressed to phase 3 and subsequently marketed products.
The Chorus Medical Advisor is responsible for the overarching medical strategy and medical oversight for multiple assets in the Chorus portfolio, across therapeutic areas and modalities. This unique breadth and depth role gives the right candidate the opportunity to provide leadership across the disciplines of clinical pharmacology, pharmacovigilance, and clinical development on multiple programs.
The Medical Advisor works with a multidisciplinary team to construct a plan to develop and test key scientific hypotheses, discharge risks regarding asset safety and efficacy, and enable effective decision-making related to asset development. For assigned assets, the Advisor is accountable for the medical and safety leadership for all phases of drug development from pre-candidate selection to proof-of-concept readout. The Medical Advisor partners with the Asset Manager (AM), who holds accountability for the scientific strategy and overall program management, and the Clinical Research Consultant (CRC), who is responsible for the operational execution of all clinical studies. The Advisor also works closely with the Toxicology lead and PK/PD lead in their role as clinical pharmacologist.
This position requires a combination of medical and scientific leadership, together with broad drug development experience. The Chorus Medical Advisor reports to the Chief Medical Officer, Chorus.
The Chorus Medical Advisor role requires:
Commitment to essentialism, simplicity, and focus
Drive to innovate and tolerance for reasoned risk
Chorus Advisor Responsibilities Include:
Medical and scientific oversight and management of clinical development strategy for assigned assets
As clinical pharmacologist, work closely with PK/PD, toxicology and ADME functional leads to select starting doses and the dose range for FHD studies, and develop a PK and biomarker strategy to effectively assess target engagement and enable selection of a dose regimen for proof of concept studies
Provide medical leadership for clinical plans including appropriate strategic objectives, study population, dose range justification, biomarkers and study endpoints, assessment of safety, and critical success factors
Author relevant protocol sections, and review and approve protocols
Contribute to informed consent documents, clinical study reports, and disclosures of research results.
Work with the team to develop medical monitoring plans, including monitoring and alert plans for key laboratory parameters.
Provide oversight and assistance in managing medical questions from investigator sites
Lead dose-escalation meetings and trial-level safety reviews
Review and assist in the preparation of regulatory documents (IND, CTA, IMPD, IB, DSURs, etc.) and responses to regulatory questions
Bring new technologies and innovation to Chorus protocols as appropriate
Serve as a member of the Protocol Review Committee (PRC)
Serve as a member of the meeting to decide on progression to first-in-human studies
Conduct due diligence on compounds that are potentially entering Chorus portfolio to assess feasibility and fit
Medical Advisor Pharmacovigilance Responsibilities also Include:
Review safety management plans for clinical studies
Work with Chorus 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 to ensure appropriate risk management
Review and approve the DCSI section of Investigator Brochures
Review of aggregated safety data and periodic safety reports to regulatory agencies per regulatory rules and processes
Conduct dose-escalation data reviews and trial level safety reviews
Work with Chorus Quality and Regulatory to develop streamlined and effective Chorus Patient Safety standards and procedures
Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
Higher degree in scientific discipline (at least MSc, PhD preferred) with strong background in pre-clinical biology and translational research
Deep expertise in oncology or neuroscience preferred, together with clinical or translational research experience in more than one therapeutic area
Critical mass of experience in early phase drug development in either academia or industry (at least 5 years)
Experience and deep understanding of GCP and the management of medical safety in the context of clinical trials (either the investigator or sponsor side)
Hands-on experience of clinical trial execution as investigator or sub-investigator
Track record of contribution to the design and authoring of clinical trial protocols
A good understanding of the principles and practice of clinical pharmacology as they pertain to early phase drug development in a multi-disciplinary team
Strong computer skills; skilled at using Word, Excel, PowerPoint
Self-starter, with excellent self-management and organizational skills and ability to prioritize
Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team, according to company travel guidance.
Remote or located in Indianapolis, Indiana.
*For internal employees, if you are currently in a technical path role, but outside of the posting band, you may apply. You will be hired at your current level. For example: Current P4 (tech ladder), Posting R1-2 tech ladder, hire will occur at P4
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As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!