Director - Clinical Design Physician - Cardiometabolic Health
Eli Lilly and Company
7 months ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Primary Responsibilities
Clinical Plan Options and Clinical Trial Protocols
- Serve as Medical leader on a cross-functional Clinical Design team; translate therapeutic area and asset strategy into clinical development program objectives and trial optionality.
- Ensure optionality addresses business/customer needs (patient, prescriber, payer, and/or regulator), aligns with product lifecycle phase, and clearly articulates tradeoffs (information gathered, risks, cost, time).
- Present program/trial design optionality to asset teams and Sr. Leaders to support prioritization; adjust optionality based on leadership feedback.
- Develop study protocols with the Design Team and partners (e.g., Cardiometabolic Health Business Unit Development Team, Discovery, Program Phase Medicine, Clinical Pharmacology).
- Provide insight into how protocol/study design impacts execution speed and efficiency.
- Contribute to asset strategy (e.g., target patient population) with the asset team.
- Contribute to business unit and global alignment of portfolio clinical strategy and asset-specific clinical plans.
Clinical Research/Trial Packages, Execution and Support
- Collaborate with clinical research staff to design and conduct clinical trials (sample size, patient commitment, timelines, grants, governance review interactions).
- Champion initiatives such as decentralized clinical trials and diversity/equity/inclusion; understand how design elements enable adoption.
- Review risk profiles to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection with Clinical Design and clinical teams.
- Participate in subject recruitment, diversity, and retention efforts.
- Support seamless transition of protocols from design to execution.
Scientific Data Dissemination/Exchange
- Ensure knowledge of and compliance with local laws/regulations, global policies, and data dissemination/healthcare professional interaction guidelines.
- Establish and maintain relationships with external experts/thought leaders and the international medical community.
- Develop and maintain collaborations with relevant professional societies.
- Contribute to scientific data dissemination, final reports, and publications.
Scientific / Technical Expertise
- Critically read and evaluate medical literature; keep up to date on competitive products and relevant scientific developments.
- Stay current on trends/projections in clinical research and practice/access in relevant therapeutic areas.
- Engage with asset teams on external activities to understand patients, medical/payer communities, and business strategy.
Shared Learning
- Identify best practices and standardize approaches to streamline program/protocol design (less burdensome, faster, less expensive).
- Collaborate with asset and execution teams to understand impact of design on protocol approval and study startup; analyze and improve approaches.
- Evolve Lilly standards, tools, and best practices across drug development.
- Provide clinical leadership on standardized/simplified processes, templates, and tools.
Basic Requirements
- Medical Doctor (MD) or Doctor of Osteopathy (DO); must be board eligible/certified in an appropriate specialty/subspecialty or have completed comparable post-medical school clinical training relevant to the country of hiring.
- At least 3 years of pharmaceutical industry experience with grounding in drug development, clinical trial principles, and scientific decision-making.
- Minimum 3 years experience across multiple areas relevant to clinical trial design (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical trials).
Additional Preferences
- Clinical trial design leadership in at least one key in-scope development phase (proof of concept, dose ranging, registration, and/or Phase 3b/4).
- Board certification/eligibility in a specialty relevant to diabetes comorbidities (e.g., cardiology, obesity medicine, nephrology, hepatology).
- Clinical research experience in one or more diabetes comorbidities.
- Strong understanding of diabetes comorbidities (pathology, pathophysiology, unmet needs, treatment standards).
- Strong interpersonal, organizational, and negotiation skills; ability to influence others cross-functionally.
- Excellent teamwork skills.
- Fluent in English; strong verbal and written communication.
- Drug development experience across core phases (proof of concept through registration).
- Bias for simplifying, reducing burden, and creating value through excellent design.
- Strong communication across modalities (presentations, meetings, protocol/regulatory document creation) with broad stakeholder groups (leaders, regulators, investigators, medical/non-medical counterparts).
- Bias for action; desire to influence a broad portfolio through clinical plan optionality and study design.
- MBA or similarly relevant training in life sciences business.
- Strong statistical foundation (including Bayesian statistics) as applied to study design (e.g., sample size, critical success factors); ability to translate concepts with statisticians.
- Willingness for limited domestic/international travel as appropriate.
- Physician eligibility requirements by training background (U.S. board eligibility/certification or LCME-compliant medical school training for non-U.S. physicians).
Additional Information (Role Logistics)
- Willing to relocate to Indianapolis.
- If unable to relocate: demonstrated ability to work effectively from a remote/hybrid location; willing to travel for business-critical events and team building.
Compensation and Benefits (as stated)
- Anticipated compensation: $198,000 - $356,400.
- Potential company bonus (for full-time equivalent employees).
- Comprehensive benefits including 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits; life insurance; time off/leave of absence; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Clinical Plan Options and Clinical Trial Protocols
- Serve as Medical leader on a cross-functional Clinical Design team; translate therapeutic area and asset strategy into clinical development program objectives and trial optionality.
- Ensure optionality addresses business/customer needs (patient, prescriber, payer, and/or regulator), aligns with product lifecycle phase, and clearly articulates tradeoffs (information gathered, risks, cost, time).
- Present program/trial design optionality to asset teams and Sr. Leaders to support prioritization; adjust optionality based on leadership feedback.
- Develop study protocols with the Design Team and partners (e.g., Cardiometabolic Health Business Unit Development Team, Discovery, Program Phase Medicine, Clinical Pharmacology).
- Provide insight into how protocol/study design impacts execution speed and efficiency.
- Contribute to asset strategy (e.g., target patient population) with the asset team.
- Contribute to business unit and global alignment of portfolio clinical strategy and asset-specific clinical plans.
Clinical Research/Trial Packages, Execution and Support
- Collaborate with clinical research staff to design and conduct clinical trials (sample size, patient commitment, timelines, grants, governance review interactions).
- Champion initiatives such as decentralized clinical trials and diversity/equity/inclusion; understand how design elements enable adoption.
- Review risk profiles to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection with Clinical Design and clinical teams.
- Participate in subject recruitment, diversity, and retention efforts.
- Support seamless transition of protocols from design to execution.
Scientific Data Dissemination/Exchange
- Ensure knowledge of and compliance with local laws/regulations, global policies, and data dissemination/healthcare professional interaction guidelines.
- Establish and maintain relationships with external experts/thought leaders and the international medical community.
- Develop and maintain collaborations with relevant professional societies.
- Contribute to scientific data dissemination, final reports, and publications.
Scientific / Technical Expertise
- Critically read and evaluate medical literature; keep up to date on competitive products and relevant scientific developments.
- Stay current on trends/projections in clinical research and practice/access in relevant therapeutic areas.
- Engage with asset teams on external activities to understand patients, medical/payer communities, and business strategy.
Shared Learning
- Identify best practices and standardize approaches to streamline program/protocol design (less burdensome, faster, less expensive).
- Collaborate with asset and execution teams to understand impact of design on protocol approval and study startup; analyze and improve approaches.
- Evolve Lilly standards, tools, and best practices across drug development.
- Provide clinical leadership on standardized/simplified processes, templates, and tools.
Basic Requirements
- Medical Doctor (MD) or Doctor of Osteopathy (DO); must be board eligible/certified in an appropriate specialty/subspecialty or have completed comparable post-medical school clinical training relevant to the country of hiring.
- At least 3 years of pharmaceutical industry experience with grounding in drug development, clinical trial principles, and scientific decision-making.
- Minimum 3 years experience across multiple areas relevant to clinical trial design (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical trials).
Additional Preferences
- Clinical trial design leadership in at least one key in-scope development phase (proof of concept, dose ranging, registration, and/or Phase 3b/4).
- Board certification/eligibility in a specialty relevant to diabetes comorbidities (e.g., cardiology, obesity medicine, nephrology, hepatology).
- Clinical research experience in one or more diabetes comorbidities.
- Strong understanding of diabetes comorbidities (pathology, pathophysiology, unmet needs, treatment standards).
- Strong interpersonal, organizational, and negotiation skills; ability to influence others cross-functionally.
- Excellent teamwork skills.
- Fluent in English; strong verbal and written communication.
- Drug development experience across core phases (proof of concept through registration).
- Bias for simplifying, reducing burden, and creating value through excellent design.
- Strong communication across modalities (presentations, meetings, protocol/regulatory document creation) with broad stakeholder groups (leaders, regulators, investigators, medical/non-medical counterparts).
- Bias for action; desire to influence a broad portfolio through clinical plan optionality and study design.
- MBA or similarly relevant training in life sciences business.
- Strong statistical foundation (including Bayesian statistics) as applied to study design (e.g., sample size, critical success factors); ability to translate concepts with statisticians.
- Willingness for limited domestic/international travel as appropriate.
- Physician eligibility requirements by training background (U.S. board eligibility/certification or LCME-compliant medical school training for non-U.S. physicians).
Additional Information (Role Logistics)
- Willing to relocate to Indianapolis.
- If unable to relocate: demonstrated ability to work effectively from a remote/hybrid location; willing to travel for business-critical events and team building.
Compensation and Benefits (as stated)
- Anticipated compensation: $198,000 - $356,400.
- Potential company bonus (for full-time equivalent employees).
- Comprehensive benefits including 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits; life insurance; time off/leave of absence; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).