Principal Clinical Research Scientist - Surgical Implants Vision

Johnson & Johnson Innovative Medicine•Milpitas, CA

1d•Hybrid

About The Position

The Principal Clinical Research Scientist - Surgical Implants Vision platform is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.

Requirements

An advanced degree in a Scientific Field is required.
Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required
Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
Understanding of biostatistics as applied to study data is required
Proficient with computers and software programs is required
Ability to travel 10% of the time is required.

Nice To Haves

A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend.
Post-graduate degree or residency is preferred
Experience with intraocular lenses is preferred.

Responsibilities

Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs
Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.)
Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
Performs other related duties as assigned by management

Benefits

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year