Clinical OB/GYN Device Development Lead
Company: Organon & Co
Location: Jersey City
Posted on: June 18, 2022
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Job Description:
Job DescriptionOrganon is a Women's Health Company that believes
in a better and healthier every day for every woman! We are a
passionate, global community of thousands dedicated to redefining
the future of women's health. Our mission is to deliver impactful
medicines and solutions for a healthier every day. But what really
makes it work at Organon is our people.We're looking for real,
passionate team players, curious innovators, forward thinkers,
empowered by the idea of shaping their career, and ready to bring
their fire to embrace change and the opportunities it brings for
progress.At Organon, you'll get to enjoy the best of both worlds:
the open, agile, collaborative culture of a start-up, and operating
at the scale of a fortune 500 company with an international
footprint that serves people in more than 140 markets.It's going to
be an exciting future-come be a part of it!Executive Director,
Women's Health - Clinical Lead - OB/GYN Device DevelopmentThe
Executive Director, Women's Health Clinical Lead is responsible for
the clinical development of the Organon portfolio, including
driving strategy, development for devices and lifecycle management.
This leadership position will work collaboratively with colleagues
in commercial, regulatory, statistics, clinical operations, CMC,
project management, manufacturing and supply, and other partner
groups to develop strategic plans across the portfolio. The person
in this role is responsible for leading (or co-leading) and
representing the scientific/clinical/medical perspectives at the
development teams in the design, implementation and execution
oversight and analysis of medical device development programs,
life-cycle management (LCM) strategies, clinical studies, and
post-approval studies. Clinical study implementation, execution and
analysis will be in an outsourced operational model however, the
person in this role provides medical oversight. This individual
will be involved in interactions with Regulatory Agencies in
support of development and LCM programs, as well as for labeling
updates and other issues for in-line products. Other activities
include the assessment of licensing candidates and participating in
due diligence evaluations; providing scientific and strategic input
into evaluations from early development through LCM.Primary
Responsibilities: Responsible for the medical and clinical aspects
of the strategy and development of the Organon WH product portfolio
including strategy development, study design, execution, analysis,
and communication of results of development and LCM
trials/initiatives, in line with GCP, GPvP and relevant Organon
SOPs Provides R&D leadership and oversight to a women's health
medical device asset team and/or development and lifecycle team
(DLT) with a focus on building a high functioning team Provides
medical and clinical support to other functional areas within the
organization involved in WH development and LCM programs Supports
Clinical Operations group as needed for identification, management
and executional and financial oversight of external vendors,
including study-related CROs Partners with commercial regarding
development and life cycle management opportunities for Organon WH
products In line with the Organon governance structure, liaise with
the senior management team for the approval of Development and LCM
plans and studies Engages and communicates effectively with
regulators, scientific leaders, and physicians, globally Provide
scientific/medical/clinical strategic input to assessment of
business development and licensing opportunities with a focus on
medical devices, including preclinical through commercial stage
opportunities, as needed Builds strong, large and globally
dispersed teams which are highly productive and efficient
Responsible for understanding global issues and helping
stakeholders address them Responsible for leveraging internal and
external networks to deliver on key priorities Helps Organon to
develop talents and provides leadership and guidance to more junior
members of ORD by sharing expertise and experience through
mentoring, anizational Relationships:This position will report to
the Vice President, Head Global Clinical Development within the
Research and Development OrganizationResources Managed (budget and
FTEs):This position manages other Clinical Directors and Clinical
ScientistsEducation Requirement:MD or equivalent medical degreeMPH
preferredRequired: Experience in Women's Health or related medical
device development is strongly preferred At least 8 years of
relevant job experience (medical devices / pharmaceutical /
biotechnology) Experience and/or solid understanding of all levels
of medical device development and also drug candidate clinical
development (Phase I-IV) Must have experience with the planning and
execution of strategies for drug product registration and
commercialization / life-cycle management Demonstrated ability: to
understand and manage, with appropriate support, the resources,
time, and budgets for assigned projects; is business-savvy and
results-oriented; to act as a subject matter expert and resource to
others on effective project management techniques and concepts to
obtain strategic alignment from key stakeholders around new
initiatives and development of a shared vision for the
organization; show strong team leadership skills in a matrix
organization; excellent written and verbal communication skills;
Proven ability to analyze, recommend, lead, and implement
strategic, and process; At least 5 years of experience leading
large and globally dispersed teams and in complex, cross-functional
and global scenarios; Proven track record of managing global issues
effectively and efficientlyWho We Are:Organon delivers ingenious
health solutions that enable people to live their best lives. We
are a $6.5 billion global healthcare company focused on making a
world of difference for women, their families and the communities
they care for. We have an important portfolio and are growing it by
investing in the unmet needs of Women's Health, expanding access to
leading biosimilars and touching lives with a diverse and trusted
portfolio of health solutions. Our Vision is clear: A better and
healthier every day for every woman.NOTICE FOR INTERNAL
APPLICANTSIn accordance with Managers' Policy - Job Posting and
Employee Placement, all employees subject to this policy are
required to have a minimum of twelve (12) months of service in
current position prior to applying for open positions. If you have
been offered a separation benefits package, but have not yet
reached your separation date and are offered a position within the
salary and geographical parameters as set forth in the Summary Plan
Description (SPD) of your separation package, then you are no
longer eligible for your separation benefits package. To discuss in
more detail, please contact your HRBP or Talent Acquisition
Advisor.Residents of Colorado: to request this role's pay range:
email: We Are:Organon delivers ingenious health solutions that
enable people to live their best lives. We are a $6.5 billion
global healthcare company focused on making a world of difference
for women, their families and the communities they care for. We
have an important portfolio and are growing it by investing in the
unmet needs of Women's Health, expanding access to leading
biosimilars and touching lives with a diverse and trusted portfolio
of health solutions. Our Vision is clear: A better and healthier
every day for every woman.Subject to applicable law, all
prospective US Organon hires will be required to demonstrate that
they have been fully vaccinated against COVID-19 with a vaccine
authorized or approved by the Food and Drug Administration (FDA),
or qualify for a medical or religious accommodation to this
vaccination requirement, as a precondition of employment.Residents
of Colorado: to request this role's pay range: email:
coloradopayact@US and PR Residents OnlyIf you require reasonable
accommodation(s) in completing an application, interviewing, or
otherwise participating in the employee selection process, please
email us at staffingaadar@.For more information about personal
rights under Equal Employment Opportunity, visit:EEOC PosterEEOC
GINA SupplementOFCCP EEO SupplementOFCCP Pay Transparency
RuleOrganon is an equal opportunity employer,
Minority/Female/Disability/Veteran - proudly embracing diversity in
all of its manifestations.Search Firm Representatives Please Read
CarefullyOrganon LLC., does not accept unsolicited assistance from
search firms for employment opportunities. All CVs / resumes
submitted by search firms to any employee at our company without a
valid written search agreement in place for this position will be
deemed the sole property of our company. No fee will be paid in the
event a candidate is hired by our company as a result of an agency
referral where no pre-existing agreement is in place. Where agency
agreements are in place, introductions are position specific.
Please, no phone calls or emails.Employee
Status:RegularRelocation:No relocationVISA Sponsorship:Travel
Requirements:Flexible Work Arrangements:Remote WorkShift:Valid
Driving License:Hazardous Material(s):Number of
Openings:1Requisition ID:R509077
Keywords: Organon & Co, Jersey City , Clinical OB/GYN Device Development Lead, Healthcare , Jersey City, New Jersey
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