Medical Director - Clinical Design, Neuroscience

Eli Lily

3+ years

Not Disclosed

Indianapolis

10 Jan. 30, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Director - Clinical Design, Neuroscience
Location: Indianapolis, Indiana, United States of America
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-73377

Overview:

Eli Lilly and Company is a global healthcare leader, united by a passion to make life better for people around the world. Headquartered in Indianapolis, Indiana, we focus on developing life-changing medicines, improving disease understanding and management, and empowering our communities through philanthropy and volunteerism. We invite you to join us in making a global impact!

Position Summary:

The Medical Director – Clinical Design for Neuroscience will play a pivotal role in driving the clinical design of programs for neuroscience therapeutic areas. This position will be responsible for leading the creation of clinical programs and trials for assets in Phases II through IV (including Real World Evidence generation). You will leverage your expertise in biopharmaceuticals, drug development, and clinical trial design to influence the direction of groundbreaking treatments and innovations.

This role requires collaboration across teams to ensure the efficient execution of clinical trials, from study design to data dissemination and medical outreach. You will work with cross-functional teams, including asset teams, business units, clinical research, and external experts, to optimize clinical design and ensure alignment with both corporate and asset strategies.

Primary Responsibilities:

Clinical Plan and Trial Design:
- Lead the design of Phase II to Phase IV clinical programs and trials, ensuring alignment with therapeutic area strategies and Lilly’s business objectives.
- Translate asset team strategies into clear clinical development objectives and trial options.
- Provide medical leadership to design teams, ensuring efficient, patient-focused trial design and execution.
- Present and adjust trial design options to senior leadership, incorporating their feedback into final protocols.
Clinical Research and Trial Execution:
- Work closely with clinical research teams to design and conduct trials that meet regulatory expectations, focusing on key elements like decentralization, patient accessibility, and recruitment/retention strategies.
- Review and adjust clinical protocols to reflect appropriate risk communication and safety assessment.
- Collaborate with clinical development teams to support participant recruitment and ensure smooth transition from protocol development to execution.
Scientific Data Dissemination and Communication:
- Engage with external experts and medical communities to disseminate clinical data and share insights.
- Collaborate on publications, presentations, and regulatory communications related to trial results and study designs.
- Maintain relationships with professional societies, healthcare providers, and industry thought leaders.
Leadership and Collaboration:
- Lead efforts to apply industry best practices and ensure consistency in clinical trial design.
- Share knowledge with cross-functional teams and promote the adoption of innovative clinical design approaches.
- Contribute to evolving Lilly standards, tools, and methodologies for drug development and clinical trial design.

Minimum Qualifications:

Medical Doctor (MD) or Doctor of Osteopathy (DO) with board certification or eligibility in an appropriate specialty/subspecialty.
At least 3 years of pharmaceutical industry experience (or comparable) with a focus on clinical trial design and execution in Phase II to IV studies.
Experience in clinical research, particularly in designing clinical programs, trials, and/or protocols, and familiarity with statistical methods, safety assessment, and investigator management.

Preferred Qualifications:

Board certification in a therapeutic area relevant to neuroscience.
Expertise in health economics, health outcomes, and comparative effectiveness research to improve clinical decision-making and trial design.
Experience in observational/pragmatic research and designing clinical programs that support regulatory and payer decision-making.
Advanced knowledge of neuroscience, including therapeutic area pathology, treatment standards, and unmet needs.
Familiarity with Bayesian statistics and their application to study design, including sample size determination and success criteria.
Global clinical development experience and an understanding of multi-national trial design and regulatory requirements.
Ability to communicate complex scientific concepts effectively with diverse stakeholders.

Additional Information:

Willingness to relocate to Indianapolis, Indiana, or work effectively in a hybrid environment if relocation is not possible.
Limited domestic and international travel as needed to support clinical programs and build internal networks.

Compensation:
The anticipated salary for this position ranges from $198,000 to $336,600 annually, depending on qualifications and experience. Eligible employees may also participate in a company-sponsored bonus program.

Benefits:

Lilly offers a competitive benefits package including medical, dental, and vision coverage, a 401(k) match, paid time off, life insurance, disability coverage, and wellness programs. We also offer educational assistance, fitness memberships, and opportunities for professional growth and development.

Equal Opportunity Employer:
Eli Lilly and Company is an Equal Opportunity Employer and is committed to creating an inclusive work environment. We do not discriminate on the basis of age, race, religion, gender, sexual orientation, gender identity, national origin, disability, or any other protected status.

#WeAreLilly

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Medical Director - Clinical Design, Neuroscience

Job Description

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