Medical Director - Clinical Design Immunology at Eli Lilly and Company

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Clinical Design Physician – Clinical Design

Purpose:

Clinical Design provides clinical program and trial design leadership and expertise within Eli Lilly – designing novel clinical programs to answer scientific questions, align with the corporate and asset strategies, and enable delivery.  The value proposition is achieved by applying design excellence competencies and principles related to value-based research, data-driven decisions, and accelerated delivery.  Clinical Design leverages internal and external information within and across therapeutic areas to provide modern, innovative solutions to Lilly’s drug development needs.

The purpose of the Clinical Design Physician is to provide Medical and scientific leadership in the clinical program and trial design of assets approaching and/or primarily in Phases II to IV.  In order to accomplish this, the Clinical Design Physician must have a deep understanding of the biopharmaceutical industry, drug development process, the therapeutic area that is relevant for the programs in development, clinical research, and clinical program and study design.  Thus, the Clinical Design Physician provides scientific, clinical, and therapeutic expertise/application, and leadership in the creation of program and trial designs that can be executed.

The Clinical Design Physician may be called upon to participate on additional items including but not limited to protocols, publications, regulatory interactions, internal executive and governance presentations, external key opinion leader interactions, medical outreach/advocacy, and industry conferences.

Primary Responsibilities

The primary responsibilities of the Clinical Design Physician are focused on the design of Phase II to Phase IV clinical programs and studies within the therapeutic area.  The core job responsibilities typically include those listed below as well as all other duties as assigned.

Clinical Plan and Trial Options and Clinical Trial Protocols

• As the Medical leader on a cross-functional Clinical Design team, translate therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality.  Optionality will address business and customer needs (patient, prescriber, payer, and/or regulator); be in alignment with phase of product lifecycle; and clearly articulate associated tradeoffs in value (data generated, risks created/discharged, cost, and time). 
• Represent program and trial design optionality to asset teams and Sr. Leaders to inform prioritization of an option that will be translated into a clinical protocol(s).  Adjust optionality in accordance with feedback from leadership. 
• Bring the medical/clinical perspective to the Design Team to inform the design of study protocols and in partnership with the other functions (e.g. Asset Team, BU Development Team).
• Provide insight into impact of study/protocol design features to feasibility, value, patient and investigator burden, and execution speed/efficiency.
• Contribute to the development of asset strategy (e.g., identification of target patient population) in partnership with the asset team.
• Contribute to business unit and global alignment of portfolio clinical strategy and the associated asset-specific clinical plans including main indication and line extensions.

Clinical Research/Trial Packages, Execution and Support

• Collaborate and complement clinical research staff in the design and conduct of clinical trials (e.g. sample size, patient commitment, timelines, grants, and governance review interactions).
• Understand how design elements influence the ability to deliver on new regulatory expectations (e.g. decentralization of clinical trials, increase racial and ethnic diversity in clinical trials) and clinical capabilities (e.g. value-based, patient accessibility, patient burden).
• Review risk profiles to ensure appropriate communication of risk to study subjects via the protocol.
• Support investigator identification and selection, in conjunction with Clinical Development.
• Partner with Clinical Development to accelerate participant recruitment and retention efforts – especially considering how design elements can create value in these areas. 
• Support seamless transition of protocols from design to execution.

Scientific Data Dissemination/Exchange

• Knowledge of and compliance with local laws and regulations, global policies and procedures, and compliance guidelines with respect to data dissemination and interactions with external health care professionals.
• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies, conferences, and consortia.
• Participate in development of scientific data dissemination and preparation of final reports and publications related to assets and/or support efforts to influence clinical design science within the industry.

Scientific / Technical Expertise

• Critically read, evaluate, and apply the relevant medical literature, status and data from competitive products, and updates with medical and other scientific developments relevant to the therapeutic area, disease state, and product. 
• Be aware of current trends and projections for clinical research, practice, and access in the therapeutic area(s) relevant to the product.
• Engage appropriately with the asset teams and the business unit development teams on relevant external activities to have good understanding of their patients, medical and payer communities, and business strategy. 
• Apply the above to the optionality recommended for clinical programs and trials and when supporting other medical-related areas as assigned.

Shared Learning

• Focus on organizational learning to proactively identify, apply, and share best practices and learnings related to program and protocol design within and outside the organization. 
• Closely collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup.  Identify and participate in opportunities to analyze experience and improve approaches.
• Work closely with counterparts in Clinical Design and therapeutic areas to continue to evolve Lilly standards, tools, and best practices that span drug development.
• Provide clinical leadership in collaboration with other Clinical Design members in appropriate development of standardized/simplified processes, templates, and tools.

Minimum Qualification Requirements:  

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty 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
• Pharmaceutical Industry experience, or similar, of at least three (3) years that provides adequate background relevant to clinical trial design of PhII to Phase IV studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical trials).

Additional Preferences:

• Board certification or eligibility within a specialty directly relevant of the therapeutic area strongly preferred.
• Clinical research experience in the therapeutic area
• Strong understanding of therapeutic area pathology, pathophysiology, unmet needs, and treatment standards in major geographies (e.g. US, EU, Japan, China, etc).
• Strong foundation in statistical science, including Bayesian statistics, as applied to study design (e.g., sample size determination, setting of critical success factors).  Ability to communicate effectively with statisticians and help translate complex principles to inform design optionality and protocols.
• Global / multi-national design or development experience
• MBA or similarly relevant training.
• Willing to relocate to Indianapolis.  If unable to relocate, demonstrated ability to work with high effectiveness from a remote location in a hybrid environment.  Willing to travel for business-critical events and to develop a strong internal network.
• Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team. 
• Fluent in English, with strong communication skills, verbal and written.
• Strong interpersonal, organizational, and negotiation skills.
• Ability to influence others (both cross-functionally and within the function) to advance objectives.
• Understanding of how design elements translate into delivery.  Bias for simplifying, reducing burden, and creation of value through excellent design.
• Strong communication skills demonstrated in a variety of modalities (e.g. presentations, meetings, creation of protocols and regulatory documents) and with broad set of stakeholders (e.g. team leaders, Sr. Leader decision makers, medical and non-medical counterparts, thought leaders, investigators, regulators).

OTHER INFORMATION

Primary internal interactions

• Clinical Design and Development teammates and leadership
• Clinical planning, clinical capabilities, and other research staff
• Team leaders and COOs
• Sr. Leaders within Clinical, R&D, therapeutic areas, and business units
• Statisticians
• Scientific communication associates
• Health outcomes research consultants/research scientists
• Regulatory directors, scientists, and associates
• Product directors, managers, and associates of the brand teams
• Legal counsel
• Therapeutic area physicians, development CRP/Ss, medical affairs CRP/Ss, early phase physicians, and Sr. Medical leaders
• Pricing, Access, and Reimbursement
• New Product Planning
• Global Marketing director or manager
• Global patient safety

External Contacts

• Scientific and clinical experts, thought leaders
• Lilly clinical investigators
• Practicing physicians/prescribers
• Regulatory agency personnel
• Professional association staff and leaders
• Disease advocates and lay organizations focused on relevant health issues
• Formulary representatives (private and government)

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