Executive Director – Clinical Development

🔥 21 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $201k - $356.4k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Serve as clinical leader for assigned early-stage CNS programs, providing medical and scientific ownership • Author and oversee clinical study protocols for orexin receptor agonists • Develop integrated clinical development plans spanning preclinical translation through late-stage trials • Collaborate with Clinical Operations to meet quality, timeline, and budget expectations • Provide medical and scientific guidance for ongoing clinical trials, including data review and safety oversight • Support biomarker strategy, dose selection, and indication expansion evaluations • Communicate clinical and scientific updates to internal teams and external stakeholders • Prepare, author, and review clinical sections of regulatory submissions, including INDs, protocol amendments, briefing documents, annual reports, safety reports, and clinical study reports • Oversee safety monitoring and adherence to GCP, pharmacovigilance standards, internal SOPs, and quality requirements • Support interactions with global health authorities • Oversee study integrity, safety, efficacy data, and risk-benefit assessments • Synthesize clinical insights and external evidence to guide portfolio strategy

🎯 Requirements

• MD in neurology or psychiatry • Board certification preferred • Clinical and/or academic experience in neurological disorders • 8+ years of pharmaceutical industry experience • Translational medicine expertise highly desired • Experience in early clinical development through late-stage development • Successful design and implementation of proof-of-concept studies • Submission experience in the neuroscience area desired • Knowledge of US and EU regulatory guidelines • Experience interacting with regulatory agencies • Outstanding written and verbal communication • Ability to work independently in a fast-paced, dynamic matrix environment • Entrepreneurial spirit with a high degree of energy and personal accountability

🏖️ Benefits

• Company bonus based partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Remote working environment • Approximately 15% travel

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