Role Summary
Senior Director Clinical Design Program Lead, Neuroscience — leads a cross-functional team in developing high-quality clinical design for specified assets, including design scenarios, and collaborates with Asset teams to provide cost, timeline, and risk transparency while enabling accelerated delivery.
Responsibilities
- Lead Clinical Design team in translating therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality, addressing business and customer needs and articulating tradeoffs in value.
- Represent program and trial design optionality to asset teams and senior leaders to inform prioritization of options translated into clinical protocols; adjust optionality based on leadership feedback.
- Provide insight into impact of study/protocol design features on feasibility, value, patient/investigator burden, and execution speed/efficiency.
- Engage other functions as determined by asset needs (e.g., Safety Committees, Regulatory, Tox/PK/ADME, TTx, Bioethics).
- Apply external benchmark data with Clinical Design Capabilities to develop clinical plans and trial designs.
- Understand how design elements influence regulatory expectations and clinical capabilities; lead the creation of risk profiles to ensure robust data delivery.
- Collaborate with Clinical Development Sr. Director to ensure design options enable accelerated delivery.
- Ensure consistent development and finalization of documents supporting the complete trial package (protocols, functional documents/plans) for smooth transition into delivery.
- Focus on organizational learning, collaborate with asset and delivery teams to improve speed to protocol approval and study startup, and evolve Lilly standards and tools.
- Provide coaching to foster inclusion and innovation; model Lilly leadership behaviors; apply lessons learned in real time.
Qualifications
- Minimum Bachelor degree in a scientific or health-related field.
- Minimum 5 years of directly related clinical trial or pharmaceutical project management experience.
- Post-graduate degree (e.g., Pharm D, M.S., or Ph.D.) preferred.
- Demonstrated knowledge and experience with project management tools and processes.
- Pharmaceutical industry experience (or similar) of at least 3 years related to clinical trial design of Ph II–Ph IV studies.
- Strong communication skills across diverse platforms; ability to influence and align teams; strong interpersonal, organizational, teamwork, and negotiation skills.
- Ability to anticipate and resolve technical, operational, or business problems; drive solutions affecting results within a business area.
Skills
- Clinical design and trial protocol development
- Cross-functional collaboration
- Risk assessment and mitigation
- Data-driven decision making
- Regulatory and statistical awareness
Education
- Bachelor degree required; post-graduate degree preferred (Pharm D, MS, PhD).
Additional Requirements
- No specific travel or physical demands noted beyond standard requirements for leadership roles.