Senior Director, Early Development Clinical Leader Ophthalmology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Cambridge, Massachusetts, United States of America, La Jolla, California, United States (inactive), Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.  

POSITION SUMMARY:

The incumbent will serve as a Clinical Leader in Ophthalmology, Neuroscience, building the Translational Medicine and Early Development Plan and leading the clinical development strategy for early-stage compound(s), in collaboration with Ophthalmology Discovery, Biomarkers, Clinical Development, and other functional partners. This position is accountable for the medical oversight, conduct, and analysis of the appropriate first in human (FIH), proof of pharmacology (POP), proof of mechanism (POM), and proof of concept (POC) studies for NME early development programs and mechanistic trials and clinical pharmacology studies supporting all phases of development for the ophthalmology portfolio.

ESSENTIAL FUNCTIONS:

• Leading the early development clinical team in the timely completion, content, and quality of key development deliverables including protocols, reports and submissions to health agencies
• Close collaboration with discovery on target identification, biomarker strategies, and NME criteria
• Overseeing active medical and scientific contribution to matrixed cross-functional Early Compound Development Teams and Clinical Teams
• Formulation and implementation of early Clinical Development Plans, including trial design and endpoints · Working with functional partner leadership (e.g., Global Clinical Operations (GCO), Regulatory, Global Medical Safety) to achieve common goals
• Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations
• Participating in formulating our strategy as a key leader in the Ophthalmology Disease Area Stronghold Leadership Team
• Providing key input into due diligence activities for Business Development opportunities
• Collaborating across disease areas and therapeutic areas to optimize the reach of Johnson & Johnson’s differentiated scientific expertise and capabilities
• Participating in cross-departmental or cross-functional projects with broad Johnson & Johnson impact
• Building and maintaining relationships with key opinion leaders
• Provides key input into diligence activities

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Education and Experience: 

• MD (or equivalent) is required.  Board certification in Ophthalmology is preferred

• Detailed and thorough understanding of retinal disorders, including inherited retinal diseases, retinal vascular diseases and degenerative diseases of the macula is required.
• Additional education: Significant academic or pre-clinical research or related experience is especially desirable. Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. Ability to interface effectively with discovery, preclinical, and late clinical development is required. Energy and enthusiasm are essential. Experience working in a Matrix environmen