BioSpace
Medical Director - Physician -Early Clinical Development, Immunology
BioSpace, San Diego, California, United States, 92189
Overview
Medical Director - Physician - Early Clinical Development, Immunology 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 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 put people first and seek determined individuals to make life better for people around the world. Position Summary We are seeking an exceptional physician scientist to join our Immunology team as Medical Director, Early Clinical Development. This role is designed for a clinical translational leader who can bridge the critical gap between discovery science and clinical application, driving the development of transformational medicines for patients with autoimmune and inflammatory diseases. The successful candidate will serve as a scientific catalyst, connecting discovery scientists, translational/biomarker experts, early clinical physicians, clinical pharmacologists, and late-stage clinicians to craft compelling therapeutic hypotheses and efficiently test them in early clinical development with line of sight to full development and approval. This role requires exceptional matrix leadership skills to influence cross-functional teams and advance both internal and external portfolio opportunities and bring transformational treatments to patients with autoimmune and inflammatory diseases.
Primary Responsibilities
Strategic Portfolio Leadership
Collaborate with discovery, translational medicine, and clinical teams to develop and refine therapeutic hypotheses for autoimmune and inflammatory diseases
Participate in prioritization of target and modality selection, integrating scientific rigor with clinical feasibility, unmet needs, and commercial potential, with particular attention to transformational potential of proposed programs
Evaluate and diligence external discovery and early clinical opportunities for potential partnerships or acquisitions
Provide scientific and clinical expertise to portfolio strategy to ensure a robust pipeline of transformational medicines in autoimmunity and inflammation
Clinical Development Excellence
In collaboration with stakeholders, design early clinical studies that efficiently test therapeutic hypotheses
Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, and other stakeholders to optimize study design and execution
Integrate translational endpoints and biomarker strategies to accelerate and maximize learning from early clinical studies and enable early decision-making
Contribute to regulatory interactions, including pre-IND, IND submissions, interactions to ex-US health authorities, as well as regulatory strategy development
Monitor patient safety and ensure compliance with GCP, FDA, ICH guidelines, and company policies
Cross-Functional Leadership & Influence
Serve as scientific and medical expert across multiple therapeutic programs simultaneously
Lead early clinical strategy in cross-functional teams through matrix influence, aligning diverse stakeholders around common objectives
Facilitate decision-making processes across discovery, development, and commercial functions
Mentor and develop junior team members while building scientific capabilities across the organization
External Partnerships & Scientific Exchange
Establish and maintain relationships with key opinion leaders and scientific experts in autoimmunity and inflammation
Represent Lilly at scientific conferences, advisory boards, and industry forums
Support business development activities through clinical scientific due diligence
Identify, evaluate, and execute strategic partnerships with CROs, biotech companies, academic institutions, and research organizations to enable the discovery and early development portfolio and strategy
Regulatory & Medical Affairs Support
Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning
Contribute medical expertise to regulatory submissions and agency communications
Support risk management planning and safety signal evaluation
Participate in data analysis, scientific publications, and medical communications
Minimum Qualifications
Medical Doctor or Doctor of Osteopathy. Board eligible or certified in Rheumatology, Dermatology, Gastroenterology, Allergy/Immunology, or related specialty, or equivalent clinical training for the country of hiring. US-trained physicians must have board eligibility or certification. Non-US trained physicians may be hired directly for employment in the US at the Chief Medical Officer’s discretion.
Non-US trained physicians must have completed education and training at a medical school that meets LCME requirements.
Preferred Qualifications
Minimum 3-5 years of pharmaceutical industry experience in clinical development
PhD in Immunology, Molecular Biology, or related field strongly preferred
Demonstrated experience in early-phase clinical trial design and execution
Strong background in translational medicine and biomarker development or application
Track record of successful cross-functional collaboration and matrix leadership
Deep understanding of immunology, autoimmune disease pathophysiology, and current therapeutic landscape
Experience with novel immunomodulatory approaches (biologics, small molecules, cell therapies, genetic medicines)
Knowledge of regulatory requirements for early clinical development (IND strategy, FDA interactions, global regulatory agencies)
Familiarity with target identification/prioritization through causal human biology in areas of high unmet need, translational endpoints, biomarker strategies, precision medicine approaches, clinical pharmacology, and PK/PD modelling
Publication record in peer-reviewed journals demonstrating scientific leadership
Experience with business development, licensing, or partnership activities
Previous regulatory interactions and FDA or other health authority meeting experience
Advanced degree or fellowship in clinical research or pharmaceutical medicine
Experience with innovative, experimental medicine trial designs and adaptive study approaches
Key Competencies
Scientific Leadership
Ability to synthesize complex scientific data and translate into actionable clinical strategies
Strategic thinking and hypothesis generation capabilities
Critical evaluation of competitive landscape and market opportunities
Matrix Leadership & Influence
Exceptional communication and interpersonal skills
Ability to influence without authority and build consensus across diverse teams
Strong negotiation and conflict resolution capabilities
Cultural sensitivity and ability to work effectively in a global environment
Execution Excellence
Autonomous work style with strong project management capabilities
Results-oriented mindset with focus on patient impact and business objectives
Adaptability and resilience in a fast-paced, evolving environment
Strong analytical and problem-solving skills
External Engagement
Ability to build and maintain relationships with external scientific and clinical communities
Strong presentation and public speaking capabilities
Professional network within autoimmune/inflammatory disease research community
Additional Information And Expectations
Travel: 25-40% domestic and international travel required
Location: Indianapolis, Boston, San Diego, San Francisco, New York
Reports to: head of Early Clinical Development, Immunology Discovery
Matrix relationships: Extensive collaboration across Discovery, Translational Medicine, Clinical Pharmacology, and other functions
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. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our ERGs offer support networks for employees. Actual compensation will depend on education, experience, and location. Anticipated wage: $217,500 - $369,600. Full-time employees may be eligible for a company bonus and a comprehensive benefits program.
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Medical Director - Physician - Early Clinical Development, Immunology 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 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 put people first and seek determined individuals to make life better for people around the world. Position Summary We are seeking an exceptional physician scientist to join our Immunology team as Medical Director, Early Clinical Development. This role is designed for a clinical translational leader who can bridge the critical gap between discovery science and clinical application, driving the development of transformational medicines for patients with autoimmune and inflammatory diseases. The successful candidate will serve as a scientific catalyst, connecting discovery scientists, translational/biomarker experts, early clinical physicians, clinical pharmacologists, and late-stage clinicians to craft compelling therapeutic hypotheses and efficiently test them in early clinical development with line of sight to full development and approval. This role requires exceptional matrix leadership skills to influence cross-functional teams and advance both internal and external portfolio opportunities and bring transformational treatments to patients with autoimmune and inflammatory diseases.
Primary Responsibilities
Strategic Portfolio Leadership
Collaborate with discovery, translational medicine, and clinical teams to develop and refine therapeutic hypotheses for autoimmune and inflammatory diseases
Participate in prioritization of target and modality selection, integrating scientific rigor with clinical feasibility, unmet needs, and commercial potential, with particular attention to transformational potential of proposed programs
Evaluate and diligence external discovery and early clinical opportunities for potential partnerships or acquisitions
Provide scientific and clinical expertise to portfolio strategy to ensure a robust pipeline of transformational medicines in autoimmunity and inflammation
Clinical Development Excellence
In collaboration with stakeholders, design early clinical studies that efficiently test therapeutic hypotheses
Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, and other stakeholders to optimize study design and execution
Integrate translational endpoints and biomarker strategies to accelerate and maximize learning from early clinical studies and enable early decision-making
Contribute to regulatory interactions, including pre-IND, IND submissions, interactions to ex-US health authorities, as well as regulatory strategy development
Monitor patient safety and ensure compliance with GCP, FDA, ICH guidelines, and company policies
Cross-Functional Leadership & Influence
Serve as scientific and medical expert across multiple therapeutic programs simultaneously
Lead early clinical strategy in cross-functional teams through matrix influence, aligning diverse stakeholders around common objectives
Facilitate decision-making processes across discovery, development, and commercial functions
Mentor and develop junior team members while building scientific capabilities across the organization
External Partnerships & Scientific Exchange
Establish and maintain relationships with key opinion leaders and scientific experts in autoimmunity and inflammation
Represent Lilly at scientific conferences, advisory boards, and industry forums
Support business development activities through clinical scientific due diligence
Identify, evaluate, and execute strategic partnerships with CROs, biotech companies, academic institutions, and research organizations to enable the discovery and early development portfolio and strategy
Regulatory & Medical Affairs Support
Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning
Contribute medical expertise to regulatory submissions and agency communications
Support risk management planning and safety signal evaluation
Participate in data analysis, scientific publications, and medical communications
Minimum Qualifications
Medical Doctor or Doctor of Osteopathy. Board eligible or certified in Rheumatology, Dermatology, Gastroenterology, Allergy/Immunology, or related specialty, or equivalent clinical training for the country of hiring. US-trained physicians must have board eligibility or certification. Non-US trained physicians may be hired directly for employment in the US at the Chief Medical Officer’s discretion.
Non-US trained physicians must have completed education and training at a medical school that meets LCME requirements.
Preferred Qualifications
Minimum 3-5 years of pharmaceutical industry experience in clinical development
PhD in Immunology, Molecular Biology, or related field strongly preferred
Demonstrated experience in early-phase clinical trial design and execution
Strong background in translational medicine and biomarker development or application
Track record of successful cross-functional collaboration and matrix leadership
Deep understanding of immunology, autoimmune disease pathophysiology, and current therapeutic landscape
Experience with novel immunomodulatory approaches (biologics, small molecules, cell therapies, genetic medicines)
Knowledge of regulatory requirements for early clinical development (IND strategy, FDA interactions, global regulatory agencies)
Familiarity with target identification/prioritization through causal human biology in areas of high unmet need, translational endpoints, biomarker strategies, precision medicine approaches, clinical pharmacology, and PK/PD modelling
Publication record in peer-reviewed journals demonstrating scientific leadership
Experience with business development, licensing, or partnership activities
Previous regulatory interactions and FDA or other health authority meeting experience
Advanced degree or fellowship in clinical research or pharmaceutical medicine
Experience with innovative, experimental medicine trial designs and adaptive study approaches
Key Competencies
Scientific Leadership
Ability to synthesize complex scientific data and translate into actionable clinical strategies
Strategic thinking and hypothesis generation capabilities
Critical evaluation of competitive landscape and market opportunities
Matrix Leadership & Influence
Exceptional communication and interpersonal skills
Ability to influence without authority and build consensus across diverse teams
Strong negotiation and conflict resolution capabilities
Cultural sensitivity and ability to work effectively in a global environment
Execution Excellence
Autonomous work style with strong project management capabilities
Results-oriented mindset with focus on patient impact and business objectives
Adaptability and resilience in a fast-paced, evolving environment
Strong analytical and problem-solving skills
External Engagement
Ability to build and maintain relationships with external scientific and clinical communities
Strong presentation and public speaking capabilities
Professional network within autoimmune/inflammatory disease research community
Additional Information And Expectations
Travel: 25-40% domestic and international travel required
Location: Indianapolis, Boston, San Diego, San Francisco, New York
Reports to: head of Early Clinical Development, Immunology Discovery
Matrix relationships: Extensive collaboration across Discovery, Translational Medicine, Clinical Pharmacology, and other functions
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. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our ERGs offer support networks for employees. Actual compensation will depend on education, experience, and location. Anticipated wage: $217,500 - $369,600. Full-time employees may be eligible for a company bonus and a comprehensive benefits program.
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