BioSpace
Senior Director-Clinical Design Program Lead, Neuroscience
BioSpace, Indianapolis, Indiana, us, 46262
Senior Director-Clinical Design Program Lead, Neuroscience
Lead a cross‑functional team in designing high‑quality clinical programs for specified assets, integrating clinical design excellence with therapeutic and phase‑specific expertise. Deliver transparent costs, timelines and risk profiles to the Asset team and collaborate with Clinical Capabilities and Clinical Development to accelerate delivery.
More About The Role Clinical Plan, Trial Options and Clinical Trial Protocols
Translate therapeutic area and asset team strategy into clear objectives and clinical development program and trial optionality, addressing business and customer needs and articulating trade‑offs.
Represent program and trial design optionality to asset teams and senior leaders to inform prioritization of an option that will be translated into a clinical protocol(s).
Provide insight into impact of study/protocol design features on feasibility, value, patient and investigator burden and execution speed/efficiency.
Engage other functions as determined by the asset need (e.g. Safety Committees, Regulatory, Tox/PK/ADME, TTx, Bioethics).
Apply external benchmark data in conjunction with Clinical Design Capabilities in the development of clinical plans and trial designs (e.g. reference trials, design analytics, country identification/allocation).
Clinical Research/Trial Packages, Execution and Support
Understand how design elements influence the ability to deliver on new regulatory expectations (e.g. decentralization, diversity) and clinical capabilities (value‑based, patient accessibility, burden).
Lead the creation of risk profiles to ensure trial design has appropriate risk mitigation to enable robust data delivery.
Collaborate with Clinical Development Sr. Director to ensure design options take into consideration the ability to enable accelerated delivery.
Ensure consistent development and finalization of documents that support the complete trial package (e.g. protocol, functional documents/plans) to enable smooth transition into delivery.
Shared Learning
Focus on organizational learning to proactively identify, apply, and share guidelines and takeaways related to program and protocol design within and outside the organization.
Collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup; identify opportunities to analyze experience and improve approaches.
Work closely with counterparts in Clinical Design and therapeutic areas to generate ideas and continue to evolve Lilly standards, tools, and protocols that span drug development.
People Development
Provide coaching within the organization that fosters inclusion and innovation, continual improvement, and external understanding and awareness.
Model the Lilly leadership behaviors.
Apply innovation and lessons learned in real time.
Minimum Qualification Requirements
Bachelor degree, preferably in a scientific or health‑related field.
Minimum 5 years of directly related clinical trial or pharmaceutical project management experience.
Other Information/Additional Preferences
Post‑graduate degree (e.g. Pharm D, M.S., or Ph.D.).
Demonstrated knowledge and experience with project management tools and processes.
Pharmaceutical Industry experience, or similar, of at least three years that provides adequate background relevant to clinical trial design of Phase II to Phase IV studies.
Strong communication skills across diverse platforms and interested parties; adept at influencing and aligning teams to advance business strategies while using interpersonal, organizational, teamwork and negotiation skills.
Ability to anticipate and resolve key technical, operational, or business problems.
Ability to drive solutions affecting results within a business area.
Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800.
EEO Statement 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. 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.
#J-18808-Ljbffr
More About The Role Clinical Plan, Trial Options and Clinical Trial Protocols
Translate therapeutic area and asset team strategy into clear objectives and clinical development program and trial optionality, addressing business and customer needs and articulating trade‑offs.
Represent program and trial design optionality to asset teams and senior leaders to inform prioritization of an option that will be translated into a clinical protocol(s).
Provide insight into impact of study/protocol design features on feasibility, value, patient and investigator burden and execution speed/efficiency.
Engage other functions as determined by the asset need (e.g. Safety Committees, Regulatory, Tox/PK/ADME, TTx, Bioethics).
Apply external benchmark data in conjunction with Clinical Design Capabilities in the development of clinical plans and trial designs (e.g. reference trials, design analytics, country identification/allocation).
Clinical Research/Trial Packages, Execution and Support
Understand how design elements influence the ability to deliver on new regulatory expectations (e.g. decentralization, diversity) and clinical capabilities (value‑based, patient accessibility, burden).
Lead the creation of risk profiles to ensure trial design has appropriate risk mitigation to enable robust data delivery.
Collaborate with Clinical Development Sr. Director to ensure design options take into consideration the ability to enable accelerated delivery.
Ensure consistent development and finalization of documents that support the complete trial package (e.g. protocol, functional documents/plans) to enable smooth transition into delivery.
Shared Learning
Focus on organizational learning to proactively identify, apply, and share guidelines and takeaways related to program and protocol design within and outside the organization.
Collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup; identify opportunities to analyze experience and improve approaches.
Work closely with counterparts in Clinical Design and therapeutic areas to generate ideas and continue to evolve Lilly standards, tools, and protocols that span drug development.
People Development
Provide coaching within the organization that fosters inclusion and innovation, continual improvement, and external understanding and awareness.
Model the Lilly leadership behaviors.
Apply innovation and lessons learned in real time.
Minimum Qualification Requirements
Bachelor degree, preferably in a scientific or health‑related field.
Minimum 5 years of directly related clinical trial or pharmaceutical project management experience.
Other Information/Additional Preferences
Post‑graduate degree (e.g. Pharm D, M.S., or Ph.D.).
Demonstrated knowledge and experience with project management tools and processes.
Pharmaceutical Industry experience, or similar, of at least three years that provides adequate background relevant to clinical trial design of Phase II to Phase IV studies.
Strong communication skills across diverse platforms and interested parties; adept at influencing and aligning teams to advance business strategies while using interpersonal, organizational, teamwork and negotiation skills.
Ability to anticipate and resolve key technical, operational, or business problems.
Ability to drive solutions affecting results within a business area.
Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800.
EEO Statement 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. 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.
#J-18808-Ljbffr