Associate Director, Clinical Science (Robotics & Digital Solutions) - MedTech Surgery

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

People Leader

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America

Job Description:

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
 

We are searching for the best talent for an Associate Director, Clinical Science to support our OTTAVA platform.  The preferred location for this role is Santa Clara, CA however Cincinnati, OH is also available as a location.  This role will work a Fully Onsite schedule with 5 days per week on-site. 

Purpose: This position will provide clinical scientific leadership for Johnson & Johnson’s OTTAVA Robotic Surgical System, leading a team of clinical scientists to deliver high-quality clinical evidence and collaborating closely with multi-functional evidence teams.

You will be responsible for:

• Lead team of clinical research professionals to develop clinical evidence strategies and deliver clinical evidence aligned to regulatory and commercial needs for the OTTAVA Robotic Surgical System.
• Contribute to and support the design of appropriate studies to meet premarket and postmarket needs.
• Strengthen capability in and drive implementation of real-world evidence to deliver cost-effective evidence solutions.
• Develop network with key surgeons in the US and globally to assist in execution of the evidence strategy.
• Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, and manuscripts.
• Support clinical scientific discussions with regulatory agencies and notified bodies to drive support of the clinical and regulatory strategy, including proposed studies; review process of evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections.
• Support the development of appropriate global evidence generation strategies (premarket studies, postmarket studies, investigator initiated, real world evidence) aligned to R&D, Regulatory, Professional Education and Commercial needs for the OTTAVA Robotic Surgical System.
• Ensure input and strong alignment from key regional MedTech leads and other strategically important countries/regions in the development of the clinical strategy.
• 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.
• Effectively manage 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 / Requirements:

• Minimum of a Bachelor’s degree in Biological Science or a related discipline is required; Advanced degree (Master’s or PhD) is strongly preferred.
• At least 8+ years of related scientific and technical experience, including leadership or management role within Clinical Research is required.
• A minimum of 2 years of people management-related experience is required.
• Experience working in Robotics is strongly preferred.
• Expertise in clinical science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and clinical trial regulations is required.
• Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including IDE/510(k)/De Novo/PMA and/or their global counterparts) is highly desired.
• Ability to lead a team of clinical scientists to provide strategic and scientific research input across NPD and LCM projects is required.
• Proven track record of contributing to clinical programs on time, within budget and in compliance to SOPs and regulations is required.
• Up to 25% domestic and international travel may be required.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required Skills:

 

 

Preferred Skills:

Clinical Data Management, Clinical Evaluations, Data Governance, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Team Management

 

 

The anticipated base pay range for this position is :

$157,000.00 - $271,400.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits