Eli Lilly and Company · 1 day ago
Sr. Director Clinical Development – Lilly Gene Therapy, Sensory
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Sr. Director, Clinical Development will be responsible for the clinical and scientific execution of global clinical programs, collaborating cross-functionally and providing leadership in clinical strategies and studies.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Lead the development of clinical strategies and plans for assigned programs and work with program teams to ensure integration of clinical strategies and plans into program targets and goals
Collaborate with cross-functional teams to support clinical programs and achieve organizational and corporate goals
Represent clinical development in program teams and cross-functional teams in decision making and problem solving, as well as development of Standard of Procedures (SOPs) and internal processes
Provide leadership, mentorship and guidance to clinical development team; manage direct reports as needed
Serves as the clinical / scientific representative for assigned clinical studies and trials; facilitate the clinical / scientific execution of clinical protocol(s) / programs (including interventional, non-interventional, validation, natural history, and registry trials / studies)
Supports the clinical operations team, including clinical trial manager, in achieving study deliverables, including adherence to budget and timelines, and developing study documents, including training materials, study procedures, and study plans
Supports the implementation and conduct of clinical studies and trials in all scientific aspects (e.g., scientific advisory committees, data safety monitoring boards, medical monitoring)
Reviews and evaluates emerging clinical trial data and oversees data interpretation; supports Communication teams in publication of data and development of materials (e.g., slide decks, posters, manuscripts, abstracts, etc.) based on clinical trial data
Supports authorship and review of clinical / regulatory documents (e.g., protocols, Investigator Brochures, clinical study reports, briefing packages, etc.); collaborates cross-functionally in planning regulatory strategy and communications
Serves as a clinical representative on internal and external teams; participates in development, review, and / or presentation of clinical data in internal and external meetings, as needed (e.g., DSMB, training, Investigator meetings, Board presentations, etc.)
Other duties as assigned or as business needs require
Qualification
Required
Master's degree or Advanced degree (ie., PharmD, PhD, etc.,) in the Life Sciences required
A minimum of ten (10) years of pharmaceutical and/or clinical experience
Preferred
Prior pharma/biotech or academic experience in rare disease, otology, audiology, gene therapy, cellular therapy, and/or medical device a plus
Proven track record of successfully conducting / supporting global clinical trials and associated development activities
Comprehensive understanding of the drug development and approval process and clinical trial design
Strong interpersonal and leadership skills required
Strong analytical and problem-solving skills, including the ability to identify and evaluate the critical factors of obstacles or opportunities; given background, experience, and judgment, able to quickly understand potential causes and deliver effective solutions
Ability to plan and think strategically and critically; intellectually curious, willing to take ownership of the assigned clinical programs and support as needed other clinical / pipeline programs
Ability to critically evaluate and analyze scientific data and literature
Strong communication skills (written and verbal) including the ability to express oneself clearly and concisely, and to message and document key progress and challenges appropriately; excellent presentation skills required
Capable of representing Lilly Gene Therapy professionally with external global opinion leaders, investigators, vendors, regulatory agencies, and others
Ability to work effectively cross-functionally, and to serve as clinical resource within the company
Self-motivated and detail-oriented with ability to prioritize and handle multiple projects
Benefits
Company bonus (depending, in part, on company and individual performance)
Eligibility to participate in a company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
Recent News
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2026-01-03
2026-01-03
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