Medical Director/ Sr. Med Director, Clinical Research - Oncology
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/. Janssen Research & Development, L.L.C, a
member of the Johnson & Johnson Family of Companies, is recruiting
for a Director/Senior Director, Clinical Rseearch Physician for
Late Development Oncology. The preferred location for this position
is Spring House, PA, but consideration could be given to other
locations. Up to 25% travel may be required. The Medical
Director/Senior Medical Director will contribute to the development
and oversee the execution of oncology clinical research studies,
ensuring consistency and quality, across the assigned development
program. This person will work closely with the clinical project
scientist team and Clinical Leader in Late Development, in
collaboration with other functional disciplines, including GCO,
Data Management, Statistics, Regulatory, QMMC, and GMS to ensure
flawless and integrated execution of study start-up planning,
oversight, and reporting of clinical studies in Oncology. Together
with the Clinical Leader, the Study Responsible Physician will
represent the clinical team in governance and committee meetings
relating to the overall strategy and operational implementation of
the clinical studies in the development plan. ESSENTIAL FUNCTIONS:
--- Lead the project scientists, ensuring appropriate training,
mentoring, and supervision across the assigned study/studies within
the clinical development program. --- Work closely with functional
partners (Data Management, Biostatistics, Regulatory, GCO, QMMC,
GMS) to ensure an integrated and strategic approach to flawless
execution and systematic oversight of study protocol(s) in late
development in close collaboration with key functional
stakeholders. --- Provide support for clinical study/studies within
a development program including: --- Working closely with the
colleague study responsible physicians and clinical project
scientists in collaboration with GCO and GMS to ensure
comprehensive medical monitoring, thorough and timely responses to
address site issues and eligibility questions, and detailed, real
time review of serious adverse events and deaths. --- Working in
partnership with colleague study responsible physicians and
clinical project scientists to ensure development of high quality
study protocols including use of consistent processes/standards
across studies. --- Collaborate with the Clinical Leader, Clinical
Project Scientists and Procurement on key study design elements
including assessment of complexity and cost of protocol-required
evaluations. --- Participate in strategic study start-up planning
in collaboration with GCO, C&G, and RTAEs including early site
assessment, feasibility, and use of simplified contract and budget
templates to accelerate rate of site activations. --- Co-lead and
oversee clinical development/authorship of informed consent forms,
eCRFs, study manuals, clinical study reports, and regulatory
submission documents. --- Work closely with Medical Writing to
support protocol or protocol amendment completion. --- Work closely
with Clinical Leader, Project Physician, Regulatory and GCO to
address protocol questions from Health Authorities and Ethics
Committees in a consistent fashion. --- Work closely with GCO to
track study recruitment and implement action plans to address early
impediments to study enrollment. --- Work closely with Quality
Management & Quality Assurance to review audit findings and
implement effective corrective action plans. --- Work closely with
clinical scientists and data management to support medical review
and data query resolution. --- Interact with clinical investigators
and Key Opinion Leaders as appropriate. --- Work with GCO to
provide oversight of CRO/study vendors' performance as it relates
to study start-up and conduct. --- Work with the Clinical Leader,
with Data Management and with Statistics on analysis of study
results and completion of study reports. --- Work with the Clinical
Leader to support the development and compilation of NDA/MAAs and
to support responses to Health Agency questions and HA
presentations post-filing. --- May review/co-author medical
publications emerging from clinical trial results. --- May act as a
liaison between company and clinical investigators, vendor
managers, and CROs. --- May be asked to assess and plan for
external clinical research opportunities in collaboration with
Clinical Leader and BD. --- May interact with medical consultants
in concert with senior clinical staff, in conducting IDMC and
Investigator meetings, as well as Advisory Boards.
Keywords: Disability Solutions, Lower Merion , Medical Director/ Sr. Med Director, Clinical Research - Oncology, Healthcare , Spring House, Pennsylvania
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