Sr. Director Clinical Development – Lilly Gene Therapy, Sensory

Job not on LinkedIn

August 5

Apply Now

Receive Emails with Similar Jobs

Eli Lilly and Company

WebsiteLinkedInAll Job Openings

Pharmaceuticals

Eli Lilly and Company is a pharmaceutical company that engages in the discovery, development, and marketing of products in the pharmaceutical industry. The company's mission is to make life better for people around the world by discovering, developing, and delivering innovative human medicines.

10,000+ employees

Founded 1876

💊 Pharmaceuticals

📋 Description

• 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

🎯 Requirements

• 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 • 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

• Comprehensive benefit program • Eligibility to participate in a company-sponsored 401(k) • Pension • Vacation benefits • 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)