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    Senior/Executive Director (Medical/M.D.) - Explor&D Translational Medicine

    Eli Lily
    5-7 years
    Not Disclosed
    Boston Massachusetts
    10 Jan. 30, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior/Executive Director (Medical/M.D.) - ExploR&D Translational Medicine
    Location: Boston, Massachusetts, USA
    Category: Research & Development
    Job Type: Full Time, Regular
    Job Id: R-76668

    Company Overview:

    At Eli 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 work tirelessly to discover and bring life-changing medicines to those who need them, improve the understanding and management of diseases, and give back to our communities through philanthropy and volunteerism.

    The ExploR&D division of Lilly Research Laboratories (formerly Chorus since 2002) is a drug development organization dedicated to accelerating the biotechnology ecosystem. As a multidisciplinary team of highly experienced drug developers, we advance investigational medicines for external sponsors with speed and efficiency. We are therapeutic area and modality agnostic, with a focus on advancing breakthrough science and creating value for our partners and patients.

    Purpose of the Role:

    The Senior/Executive Director, ExploR&D Translational Medicine will be responsible for providing medical strategy and oversight for multiple assets within the ExploR&D portfolio. The role offers an opportunity to lead early-phase clinical development across various therapeutic areas and modalities, working with external biotechnology companies, venture capital funds, and internal Lilly therapeutic area experts. This position will ensure that medical and safety leadership is provided for assets across all phases of drug development from candidate selection to proof-of-concept readout.

    Key Responsibilities:

    Medical Strategy and Leadership:

    • Provide overall medical and safety leadership for multiple assets in early-stage clinical development.
    • Construct and execute clinical development plans, ensuring the testing of key scientific hypotheses, assessing safety and efficacy risks, and enabling effective decision-making.
    • Collaborate with project team leaders to develop and execute development plans in partnership with clinical research teams, toxicology, and pharmacokinetics.
    • Provide leadership for clinical plans, including strategic objectives, study population, dose range justification, biomarkers, and study endpoints.
    • Review and approve key documents such as clinical protocols, informed consent documents, clinical study reports, and research disclosures.

    Clinical Development and Safety:

    • Lead the design and execution of early-phase clinical trials, ensuring appropriate safety management, regulatory compliance, and interactions with external partners (e.g., CROs, biotechnology startups).
    • Work closely with toxicology and pharmacokinetics teams to establish dose ranges and inform dose escalation strategies for proof-of-concept studies.
    • Serve as the medical monitor for clinical trials, overseeing adverse event management, risk assessment, and safety reviews.
    • Contribute to regulatory submissions and communications (e.g., IND, CTA, IMPD) and provide medical expertise to regulatory responses and safety documentation.

    External Collaborations and Networking:

    • Interface directly with external biotechnology companies, including startups and venture capital firms, to ensure alignment on medical and scientific development strategies.
    • Develop and maintain relationships with thought leaders, external experts, and professional societies relevant to therapeutic areas of interest.
    • Participate in scientific data dissemination and contribute to the preparation of scientific publications and research results.

    Medical Leadership and Team Development:

    • Provide medical leadership and guidance to multidisciplinary teams, enhancing the development of internal standards, tools, and best practices.
    • Continuously evolve ExploR&D standards and processes to drive innovation in clinical development.
    • Mentor and share knowledge within the ExploR&D team, enhancing internal capabilities and fostering professional growth.

    Basic Qualifications:

    • Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.), with board eligibility or certification in an appropriate specialty or equivalent post-medical school clinical training.
    • At least 3 years of direct experience in the pharmaceutical industry or relevant clinical experience.
    • Strong computer skills in Word, Excel, PowerPoint, Teams, and SharePoint.

    Additional Preferences:

    • Clinical pharmacology and/or translational biology experience (Master’s or Ph.D. is a plus).
    • 5-7 years of experience in early-phase clinical trials within the pharmaceutical industry, including experience authoring and executing Phase 1 and Phase 2a protocols.
    • Deep understanding of Good Clinical Practice (GCP) and the management of medical safety in clinical trials.
    • Experience in authoring and reviewing regulatory documents (e.g., IND, IMPD, IB, etc.).
    • Ability to evaluate complex scientific concepts and quickly integrate them into clinical development plans.

    Other Information:

    • Hybrid role based in Boston, MA or Indianapolis, IN. Remote work may be considered for exceptional candidates.
    • 25% travel may be required.
    • Competitive salary and benefits package, including eligibility for company bonuses, comprehensive healthcare, retirement plans, and wellness benefits.

    Lilly is an Equal Opportunity Employer:

    Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities when applying for positions. If you require accommodation during the application process, please submit an accommodation request via the provided link.

    #WeAreLilly

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