Another JNJ job posting for human clinical studies personnel - Titan going to begin Human Clinical Studies in Q4 - pretty solid connection, I mean coincidence, yet again...
Associate Director, Clinical Research, Digital Surgery
Johnson & Johnson
Cincinnati, OH
Apply on Johnson & Johnson Job Search - Jobs
Full-time
Johnson & Johnson's Family of Companies is recruiting for an Associate
Director, Clinical Research, Digital Surgery Platform, to be located in Cincinnati,
Ohio and may require up to 25% domestic and international travel.
Johnson
and Johnson Medical Device Companies
Ethicon’s long-term vision is to use
digital technology as part of a holistic approach to surgery across the episode
of care to enhance surgical efficiency, promote better clinical outcomes and
increase patient satisfaction. This unique position will provide scientific
leadership for Ethicon’s Digital Surgery Platform, collaborating closely with
the multi-functional evidence teams: Medical, Clinical, Pre-clinical and Health
Economics and Market Access.
Thriving on a diverse company
culture, celebrating the uniqueness of our employees and committed to
inclusion. Proud to be an equal opportunity employer. Responsibilities
include:
• Lead team of clinical research
professionals to develop and deliver appropriate global evidence generation
strategies (Pre-and Post-Market approval- studies, Investigator Initiated, Real
World Evidence) aligned to the needs of the R&D, Regulatory, Professional
Education and Commercial Digital Surgery platform
• Ensure
input and strong alignment from key regional MD CR&D leads and other
strategically important countries/regions in the development of the
clinical evidence generation strategies;
• Contribute
and support the design of appropriate clinical trials to meet the
premarket and post market needs;
• Strengthen
capability in and drive implementation of real-world evidence to deliver
cost-effective evidence solutions for Digital Surgery platform
• Identify
areas of highest impact for the Digital Surgery portfolio, create and
implement solutions that significantly impact ROI, and communicate impact
across the organization
• Develop
network with key surgeons in EU and US to assist in execution of Digital
Surgery clinical trials for registration in both regions
• Lead
teams to ensure appropriate interpretation and dissemination of all
evidence generated, based on EDS, including CSRs, abstracts, manuscripts,
etc.
• Support
clinical scientific discussions with regulatory agencies / notified bodies
to drive support of the clinical and regulatory strategy, including
proposed clinical investigations; review process of clinical evidence
generated for marketing authorization, line extensions, etc., including
during sponsor regulatory inspections;
• Provide
scientific, technical, and strategic assessment and/or oversight on New
Business Development opportunities, and support acquisition of innovative
products/devices that will position our company for future growth and
success
• Demonstrate
the ability to influence, shape and lead teams
• Develop
talent to provide strategic and scientific clinical research capability,
including responsibility for professional development of direct reports
• Have
experience in effective management of project budget processes;
• Through
transparent leadership, be a key leader in developing a high-performing
team with a global culture;
• Build
successful relationships internally and develop partnerships with key
business partners and customers/investigators
Qualifications
• A minimum of a Bachelor’s
degree in Biological Science or a related discipline is required. An
advanced degree (Master’s or PhD) is preferred
• A
minimum of 8 years of related scientific / technical experience, including
leadership / management role within Clinical Research is required
• A
minimum of 2 years of people management-related experience is required for
this role
• Experience
working in Digital Surgery/Robotics Area is strongly preferred
• Expertise
in clinical research science and processes along with a broad and
extensive understanding of product development processes, team dynamics,
related healthcare market environment, clinical trends, and global
clinical trial regulations is required
• Experience
in support of global regulatory submissions for medical devices,
biologics, or drugs (including PMA/BLA/NDA and/or their global
counterparts) is preferred
• Ability
to lead a team of clinical scientists to provide strategic and scientific
clinical research input across NPD and LCM projects is preferred
• Proven
track record of contributing to clinical programs within a clinical or
surgical research setting, on time, within budget and in compliance to
SOPs and regulations is required
• This
position will be located in Cincinnati, Ohio and may require up to 25%
domestic and international travel
Johnson & Johnson is an Affirmative Action and Equal
Opportunity Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual orientation,
gender identity, age, national origin, or protected veteran status and will not
be discriminated against on the basis of disability
Primary Location
United States-Ohio-Cincinnati-
Organization
Medical Device Business Services, Inc (6029)
Job Function
Clinical Research non-MD
Requisition ID
0307190723
AI
