AddressDescription
Biosense Webster (BWI) Inc. is recruiting for a Senior Director, Clinical Science & External Research . This position will be based in the J&J MedTech office in Irvine, CA.
Drawing on a century of working alongside clinicians, we are focused on solving the world’s most pressing healthcare challenges through innovation at the intersection of biology and technology.
Always beginning with the unmet needs of patients, we break through barriers to develop and deliver medical technologies that help save lives, change the course of disease, and restore health. Our innovations enable clinicians to reach the hardest-to-reach parts of the body, treat with pinpoint precision, restore anatomy, and reimagine healing and recovery.
Together, we will continue to develop smarter, less invasive, more personalized solutions to tackle the leading causes of mortality and the most complex diseases around the world.
Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for our MedTech and innovative health products. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.
This leader is accountable for leading the clinical evidence generation strategy, scientific communications, and External Research collaborations including the IIS process, collaborative studies, RWE, and post-market external registries, ensuring compliance with company policies and legal requirements. This individual is responsible for establishing and maintaining a strong partnership with the Clinical Research leader and team, aligning with global cross-function teams on developing and executing on evidence generation and dissemination strategies.
POSITION DUTIES & RESPONSIBILITIES:
Under the general direction of the Leader of Clinical/Preclinical/Medical Affairs for the Franchise and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:
• Leads the development of evidence generation strategy across product platforms within the Franchise to ensure robust scientific review with appropriate partners within preclinical/clinical/medical team and BSDM etc. This may include conducting strategic assessments (e.g., gap analysis) via literature review and providing clinical/scientific support to developing claims, pre- and post-market clinical strategy, scientific communication, and publication plan for key products in development and for legacy products.
• Connects with the appropriate internal and external experts to develop a strategy to determine when and how to utilize internal data and external data, research, and registries to support evidence needs to demonstrate the value of new and existing products.
• Leads the investigator-initiated study (IIS) review, implementation and management, and partners with regional teams and Franchise leaders to align and integrate the IIS evidence strategy with the larger global evidence generation strategy for the Franchise.
• Provides independent review and input into development of clinical trial protocols as needed.
• Leads publication planning, execution, and downstream evidence dissemination.
• Working with Clinical counterparts in other Franchises, creates a community of practice to assess proposed new / amendments to policies / regulation / guidance documents.
• Provides technical leadership to support both internal and external taskforces involved in the development of new / proposed amendments to policies, regulations, etc as needed.
• Connects with research community to understand and translate advances in Clinical Science into the clinical research strategies and protocols.
• Possesses advanced understanding and maintains current knowledge of regulatory requirements and industry standards on scientific communication and publication development. Serves as an internal SME on these topics and will collaborate with counterparts in the other Franchises as well as with US and EMEA Regulatory partners.
• Develops and maintains relationships with external physicians (e.g., key opinion leaders, vendors, etc.) for long-term research collaborations and business opportunities and to understand and communicate research needs.
• Responsible for managing one or more direct reports, including clinical affairs manager from Canada. May directly or indirectly manage external contractors or vendors.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
• BS degree with a minimum of 10 years of related scientific/technical experience is required
• An advanced degree is preferred
• Minimum 6 years of management experience in Clinical or Medical Science role is required
• Strong experience in medical devices, especially in clinical and surgical research science, is required
• Excellent written and oral communication, and presentation skills are required
• Experience in scientific communications including publication and evidence dissemination is highly preferred
• Experience with medical writing and systematic literature review is highly preferred
• Deep expertise with medical device clinical development is required
• Ability to understand and distill complex scientific information is required
• Knowledge of medical device/pharmaceutical research processes is required
• Ability to work in a collaborative and multi-disciplinary environment is required
• Ability to travel (domestic and international) up to 30% of the time is required
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
The anticipated base pay range for this position is $187,000 to $322,000.
