Sr. Director - Chorus Clinical Research Physician (Crp) And Head Safety Physician

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.
ORGANIZATION OVERVIEW: Chorus, a Division of Lilly Research Laboratories, is a virtual drug development organization that specializes in efficient drug development plans, advancing assets from candidate stage through to clinical proof-of-concept studies. As a multidisciplinary team of highly experienced drug developers, we seek to advance a portfolio of New Molecular Entities originated from both Lilly and external sponsors with speed and efficiency.
Since its creation in 2002, Chorus has supported over 90 development programs (a mix of Lilly-sponsored and non-Lilly sponsored programs) throughout North America, Europe, and Asia, some of which have progressed to phase 3 and subsequently marketed products. We are therapeutic area and modality agnostic, and seek to advance breakthrough science and create value for our partners and patients.
PURPOSES OF THE JOB: This dynamic role encompasses duties across drug safety and clinical research. The Senior Director, Chorus Clinical Research Physician (CRP) and Head Safety Physician is responsible for the overarching medical strategy and medical oversight for multiple assets in the Chorus portfolio, across therapeutic areas and modalities, and has accountability for coordination of physician safety support across the Chorus Portfolio. 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 biotechs and venture capital funds, as well as internal Lilly therapeutic area experts; and the opportunity to gain skills across both clinical research and drug safety. This is an ideal role for a drug safety physician seeking to expand their clinical research/clinical development experience.
Chorus Clinical Research Physician (CRP) and Head Safety Physician: Core Job Tasks: For assigned assets, the CRP 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.The CRP 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 CRP also partners with the Toxicology lead, especially for First-in-Human (FIH) assets, and the PK/PD lead, in establishing 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.Authors, reviews, and approves key documents, including protocols, risk profiles, informed consent documents, clinical study reports, and disclosure of research results.As a delegate of the Head of Medical and/or Chief Medical Officer, carries accountability for leadership and oversight of medical safety matters, closely liaising with vendors, Chorus Regulatory, Lilly Safety group, and study and project teams.Core Job Responsibilities: Clinical Plan and Study Documents:
Strong ability to grasp complex scientific concepts quickly (critically reviewing and evaluating available information on asset and disease biology) and applying this effectively to development programs.Develop understanding of the disease process, patient attributes, concomitant medication usage, and other therapeutic issues in a wide variety of therapeutic areas.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 Chorus 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.Provide clinical and strategic leadership to study teams for benefit: risk assessment language across the portfolio.Clinical Study Execution:
Provide medical leadership in early development study conduct including study design, protocol writing, regulatory documents, CRO interactions, study start up, investigator interactions, data monitoring, health authority interactions, analyses, and study reports.Serves as a medical monitor and safety physician for ongoing trials.Provide oversight and assistance in managing medical questions from investigator sites.Lead dose-escalation meetings and trial-level safety reviews (TLSR's).Safety Management:
As a delegate for the Head of Medical and/or the Chief Medical Officer, serve as a single point of accountability for medical safety matters across the portfolio, and the key physician bridge across varied pharmacovigilance processes and stakeholders.Serve as the key liaison between Lilly Safety organization and the Chorus Physician team.Support, establish, and maintain medical safety processes across the Chorus portfolio where applicable, with a continual process-improvement mindset.Manage safety for assigned clinical stage Chorus compounds and clinical trials, serving as medical monitor.Work with the team to develop safety monitoring plans, including monitoring and alert plans for key laboratory or other safety assessment parameters.Lead the Chorus Asset Safety Management team (CASMAT) and escalate safety concerns as appropriate to the Chorus Safety Review Committee.Provide guidance to team members about medical and safety issues, data cleaning, data summaries and study progress.Review and approve trial level safety review plans for clinical studies. Lead and ensure appropriate documentation of regular trial safety reviews for early phase studies, either in the form of dose escalations or periodic data reviews of ongoing studies.Review and approve 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, 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.Review of aggregated safety data and periodic safety reports to regulatory agencies per regulatory rules and processes and author key sections of the update as appropriate.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.Clinical Pharmacology:
Work closely with PK/PD, toxicology and ADME functional leads and, as part of the multidisciplinary team, to:Select starting doses and the dose range for Phase 1 studies.Develop a PK and biomarker strategy to effectively assess target engagement.Integrate the totality of early phase data to select an appropriate dose regimen for proof-of-concept studies.Scientific Communication:
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.Effective Communication:
Demonstrate excellent oral and written communication skills.Effectively respond to queries/comments from Investigators, Regulatory Agencies, Ethical Review Boards, CROs.Communicate effectively in varied settings (e.g., study start-up and update meetings, internal governance boards, Regulatory Agencies, external partners regarding clinical safety issues).Communicate with audiences from multiple scientific disciplines and at a variety of different levels.Medical Leadership:
Share learning within Chorus and feed learning back to LRL in order to effectively enhance and grow internal capabilities and productivity.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.Ensure drug development shared learning amongst colleagues within and, where applicable, outside of Chorus.Work closely with Chorus colleagues to continue to evolve Chorus standards, tools, and best practices across clinical development.MINIMUM JOB REQUIREMENTS: MD or DO with experience in clinical trials management within the pharmaceutical industry.ADDITIONAL PREFERENCES: Experience in drug safety as a drug safety physician/global safety officer is strongly preferred, but other pharmacovigilance experience will be considered. Some pharmacovigilance experience is required.Experience in immunology, oncology, and/or metabolic/endocrine disease areas a plus.Knowledge and experience in conducting development activities in compliance with all local laws and regulations and ICH guidelines.Strong knowledge of GVP and experience in case management, signal detection, benefit:risk assessment.Possess a good understanding of clinical pharmacology.At least 3 years experience directly in the pharmaceutical industry and at least 5 total years in the industry or adjacent activities which must include experience in drug safety and may include:Hands-on experience of clinical trial execution as an investigator or sub-investigator.Experience in the management of medical safety in the context of clinical trials (either the investigator or sponsor side).Track record of contribution clinical trial protocols and/or study conduct.Strong computer skills; Word, Excel, PowerPoint, Teams and SharePoint.Experience presenting data to varied stakeholders.Proactive self-starter, with excellent time management and organizational skills and ability to prioritize.Strong problem-solving skills.Strong leadership and interpersonal skills.Ability to represent the organization to key external stakeholders, including external companies, health care providers, and key medical experts.Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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