Senior Director, Clinical Science & External Research
Company: Disability Solutions
Location: Irvine
Posted on: April 20, 2024
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Job Description:
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.
Keywords: Disability Solutions, Placentia , Senior Director, Clinical Science & External Research, Executive , Irvine, California
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