Senior Director, Clinical Development

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $201k - $356.4k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 1 day.
• Jobs at this company usually fill in 21 days.

Apply Now

Check your resume score

Customize resume + cover letter

Find Similar Remote Jobs

☆ Save☑️ Mark as applied❌ Hide

Report problem

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 the primary point of contact for clinical development activities at program and clinical trial levels • Oversee and monitor overall risk, safety, benefit/efficacy to patients, compliant trial execution, and data integrity • Establish relationships and communication with KOLs, investigators, and site medical personnel • Lead clinical development strategy and innovative approaches for the asset’s clinical pathway • Contribute to publication strategy and planning, author publications and posters, and present at conferences and meetings • Participate in regulatory and health authority interactions • Contribute to regulatory activities, submissions, clinical sections of regulatory packages and applications, annual reports, safety reports, and clinical study reports • Author asset- and clinical-trial-level plans, charters, and documents • Determine innovative, patient-centric, cost-efficient clinical trial designs that meet business goals • Review, analyze, and interpret clinical trial data, including protocol deviations • Lead asset-level clinical sub-teams and contribute leadership to the program team • Lead asset- and trial-level medical forums, including safety review committees, advisory boards, KOL meetings, patient case reviews, and cohort review meetings • Attend and present at core team meetings, investigator meetings, and site visits as needed • Liaise with cross-functional partners, vendors, and CROs to progress clinical studies on schedule • Provide clinical evaluation and interpretation of pre-clinical results • Remain current on orexin agonists and relevant therapeutic areas through literature review, KOL and expert interactions, and scientific meetings

🎯 Requirements

• MD required, including internationally recognized equivalent • MD/PhD strongly preferred • Minimum 5 years of combined experience across academia, clinical practice, pharma/biotech industry, etc. • Minimum 2 years of pharmaceutical/biotech industry experience, including managing clinical development programs and clinical trials • Substantial experience supporting CNS/neuroscience drug development required • Willingness to deliver project and tactical level work • Excellent working knowledge of regulations across various agencies, including FDA and EMA, and GCP and ICH guidelines • Experience leading and authoring clinical development inputs into regulatory submissions, including INDs, CTAs, NDA/BLAs and designation applications • Experience representing clinical development in agency interactions • Experience authoring and guiding teams with key asset and clinical trial level plans and documents • Strong knowledge of clinical development strategy, clinical trial design, regulatory pathways, biostatistics methodologies, and analysis and interpretation of translational medicine, clinical and research data • Excellent written and oral communication skills • Proven ability to work collaboratively, take initiative, solve complex issues, and deliver results in a fast-paced, team-based matrix environment • Sound judgement in handling complex, confidential, and highly regulated information • Ability and willingness to travel as required

🏖️ Benefits

• Company bonus depending on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision and prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume