Associate Director, Clinical Development - Gastroenterology
Company: Disability Solutions
Location: Spring House
Posted on: April 20, 2024
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Job Description:
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
https://www.jnj.com/. Johnson and Johnson is recruiting for an
Associate Director, Clinical Development - Gastroenterology , to be
located in Spring House, PA. Remote work options may be considered
on a case-by-case basis and if approved by the Company. As
Immunology Leaders, we know immunology is vital to human health.
Driven by a relentless focus on patient unmet needs, we will
redefine treatments for immune diseases by delivering
transformational and accessible therapies and regimens to patients
with immune-mediated disease. For more than two decades we have
been a world leader in the development of transformational
medicines, establishing one of the strongest, first-in-class
portfolios and pipelines in the industry, including the first tumor
necrosis factor (TNF) inhibitor, and first interleukin (IL)-12 and
IL-23 inhibitors. We tirelessly push the boundaries of science and
creativity, applying our deep disease insights, novel pathway
science, new technologies, and treatment modalities to restore
immune homeostasis. Our mission drives us. Our patients inspire us.
We collaborate with the world for the health of everyone in it. We
are guided by our Credo. Thriving on a diverse company culture,
celebrating the uniqueness of our employees and committed to
inclusion. Proud to be an equal opportunity employer. POSITION
OVERVIEW The Associate Director, Clinical Development is part of
the Development Physician team at Janssen Immunology, with clinical
development and medical/scientific responsibility for Phase 2 and 3
programs, and providing applicable disease area expertise
(including Gastroenterology for the Therapeutic Area [TA]). The
Associate Director, Clinical Development is a key member of
cross-functional teams focused on the creation and execution of
integrated clinical development plans which seek to produce
transformational and accessible therapies for patients with
immune-mediated inflammatory disease. The role involves close
partnership with project Clinical Scientists and extensive
collaboration with colleagues across disciplines, including
Discovery, Translational Science & Medicine, Clinical Pharmacology,
Biostatistics, Data Science, Medical writing, Clinical Operations,
Global Medical Safety, Regulatory Affairs, Quality, Medical
Affairs, Commercial and Market Access. Beyond individual internal
drug development programs, the Associate Director, Clinical
Development also contributes to innovation initiatives in
disease/pathway areas, drug development processes, and external
partnering/business development. The position will support clinical
development strategy, and clinical trial protocol design,
development, and execution. The position will also have a
leadership role in the conduct of clinical trials, investigator
meetings, regulatory interactions, and study and submission
document writing. The successful candidate will have strong
communications skills, relevant clinical and matrix workplace
experience, and a high degree of curiosity, flexibility,
innovation, entrepreneurship, and drive to address unmet medical
needs for patients. RESPONSIBILITIES: --- Medical/scientific
responsibility for Phase 2 and 3 clinical trials/programs,
including: o Design: concepts, project plans, protocols, case
report forms, operational and analytic plans o Execution:
regulatory/Ethics Committee applications, start-up, enrollment,
medical monitoring, database lock, close-out activities o Analysis:
interpretation of clinical and scientific data o Reporting:
internal communications, external scientific disclosure, regulatory
filings (including marketing applications and associated
activities) --- Medical/scientific responsibility for
compound-level right-to-operate elements, including Investigator
Brochures, Safety Update Reports, Risk Management Plans, and
product labelling --- Medical/scientific responsibility in
interactions with internal cross-functional partners and senior
leaders, external medical/scientific investigators/experts/leaders,
and Health Authorities --- In collaboration with Compound
Development and Disease/Pathway Area Stronghold teams,
development/execution of: o Disease/pathway area strategies
including indication/target prioritization, future treatment
paradigms incorporating treatment sequences and combinations,
precision medicine/patient stratification o Novel outcome measures
for inclusion in clinical trials/practice/labelling ---
Medical/scientific responsibility in business development
activities, including assessment/due diligence for external
program/asset partnering opportunities --- Participate in
cross-departmental/cross-functional projects with broad Janssen
impact EXPECTATIONS The successful candidate will have a passion to
drive programs into diverse immune-mediated inflammatory disease
indications, based on scientific rationale and unmet medical needs.
General expectations --- Strong passion to drive programs into
diverse indications, based on scientific rationale and unmet
medical needs --- Strong potential to work, collaborate,
communicate, and influence in a cross-functional matrix
environment, delivering Immunology TA strategies with a one-team,
one-portfolio mindset --- Foundational understanding of clinical
research / drug development, with strong potential to drive
innovation and maintain high standards of research conduct ---
Develop and maintain an external network including credible
relationships with scientific leaders, key clinical opinion
leaders, and regulatory officials as needed to advance the
Immunology portfolio --- Represent Janssen Immunology in a highly
professional manner internally and externally
Keywords: Disability Solutions, Philadelphia , Associate Director, Clinical Development - Gastroenterology, Healthcare , Spring House, Pennsylvania
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