Clinical Research and Development Lead (CRDL), CMV Vaccine
Company: GlaxoSmithKline
Location: Rockville
Posted on: August 4, 2022
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Job Description:
Site Name: USA - Maryland - Rockville Posted Date: Jan 28 2022
Are you energized by an opportunity to accelerate and deliver a
clinical data strategy that drives compliance and efficiency? If
so, this Clinical Research and Development Lead (CRDL), CMV Vaccine
role could be an exciting opportunity to explore. Our Vaccines
scientists work in three global R&D centers, in Belgium, Italy,
and the USA - and a fourth virtual R&D centers dedicated to
mRNA technology. We are focused on discovering and developing novel
vaccines across a range of pressing public health threats. Our
efforts are concentrated on those possible vaccines which may offer
significant improvements over existing options or target diseases
for which no vaccines yet exist. Our approach is to make the most
of our own expertise and experience, while at the same time forming
complementary partnerships and alliances with others who bring
different kinds of expertise. Our vision for the world, where
everyone has access to the vaccines they need, depends on a steady
supply of great ideas and brilliant science. We have much to offer
and through collaboration we can achieve so much more. We currently
have an opportunity for Clinical Research & Development
Lead/Clinical Development Director to join our CMV team. Reporting
to the Clinical and Epidemiology Research & Development Project
Lead (CEPL) you will conduct Phase I-IV Clinical Development
activities within our accelerated CMV Vaccine Program to lead
Clinical Development activities in order to ensure the high quality
and on-time delivery of all clinical data that will allow
world-wide registration in compliance with the clinical development
plan, good clinical practices (GCP), and GSK Vaccines standard
operating procedures (SOP). This role will provide YOU the
opportunity to lead key activities to progress YOUR career, these
responsibilities include some of the following... Where applicable,
lead matrix team, to author clinical development plans, design
clinical trial protocols, and author clinical study reports and
publications of high scientific, operational, and ethical
standards. Ensure consistency of data within program and across
projects. Reporting accountability will be to Clinical and
Epidemiology Research & Development Project Lead (CEPL).
Responsible for the clinical portion of file submission and its
registration process, under the leadership and direction of the
CEPL. Bear primary responsibility and accountability for scientific
and medical quality and timeliness of clinical trial synopses and
protocols and all clinical trial documents, including the
Investigator's Brochure and the Clinical Study Report. Where
applicable, support or act as the delegate of the Clinical and
Epidemiology Research & Development Project Lead (CEPL) in
representing GSK Vaccines in meetings with health authorities and
the scientific community, networking with thought leaders and
international agencies as needed. If applicable, represent clinical
development within Vaccine Commercialization Team (VCT), Discovery
Performance Unit (DPU), Protocol Review Board (PRB), Toxicology
Working Group (TWG), etc. If appropriate, support the CEPL or serve
as delegate of the CEPL as the principal liaison to Internal Safety
Review Committee (iSRC) and Independent Data Monitoring Committee
(IDMC) and Firewall Teams (FWT). Supports internal process
improvement activities and initiatives involving coordination of
multidisciplinary working team across departments (clinical,
safety, regulatory) and maintains contacts with internal and
external stakeholders (e.g., CDC, NIH, ACIP/NITAGs, and other
academia / government institutions etc...). Assumes accountability
for the medical/legal and human safety aspects of the clinical
program (if not an MD, assembles and transmits timely summaries of
clinical safety data for review by competent medical officer).
Responsibility for Data Listing review for the medical portion of
data listing for individual studies, assure medical consistency
within trial and across trials within the CMV Vaccine program.
Address scientific and medical issues related to one or more
projects promptly. Pay special attention to serious adverse events
occurring during clinical trials and potential safety signals.
Liaise with safety and pharmacovigilance teams and serve on SRT
(Safety Review Team) as clinical program stakeholder. In clinical
programs, together with PV analyze safety and potential signals and
escalate accordingly. Publishes clinical data in peer review
journals and presents in external scientific meetings / congresses.
Maintains and expands knowledge in medical and scientific
competencies (as appropriate), vaccinology and trial methodology.
Why you? Basic Qualifications: We are looking for professionals
with these required skills to achieve our goals: MD or PhD Sound
scientific background required to critically evaluate all
scientific aspects of vaccinology / immunology / medicine
development. 3+ years industry experience or minimum 10+ years of
experience working in scientific or medical institutions (academic
and/or government, including regulatory agencies). Experience in
vaccines, clinical research, translational science, and biomedical
research regulations, including ICH and GCP. Experience in the
causes of infectious diseases, health interventions and the global
public health landscape. Preferred Qualifications: If you have the
following characteristics, it would be a plus: License to practice
medicine (MD) and board and/ or professional certification Previous
vaccinology and/or immunology experience Experience in leading or
supporting a biologics license application or major sBLA Good
theoretical and practical knowledge in clinical research. Ability
to translate scientific skills in the field of vaccines and
clinical research into business-driven strategies. Ability to work
well within a matrix environment, balance priorities, and handle
multiple tasks through good planning, project administration, and
organizational skills. Effective ability to prioritize tasks and
deliver on deadlines, with high performance standards and a
commitment to excellence. Needs to possess highly effective
communication skills and be capable of presenting ideas and data
clearly to various audiences Excellent knowledge of spoken and
written English Why GSK? Our values and expectations are at the
heart of everything we do and form an important part of our
culture. These include Patient focus, Transparency, Respect,
Integrity along with Courage, Accountability, Development, and
Teamwork. As GSK focuses on our values and expectations and a
culture of innovation, performance, and trust, the successful
candidate will demonstrate the following capabilities: Agile and
distributed decision-making - using evidence and applying judgement
to balance pace, rigour and risk Managing individual and team
performance. Committed to delivering high quality results,
overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change. Sustaining
energy and well-being, building resilience in teams. Continuously
looking for opportunities to learn, build skills and share learning
both internally and externally. Developing people and building a
talent pipeline. Translating strategy into action - a compelling
narrative, motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing trusted
stakeholder relationships internally and externally. Budgeting and
forecasting, commercial and financial acumen. *LI-GSK If you
require an accommodation or other assistance to apply for a job at
GSK, please contact the GSK Service Centre at 1-877-694-7547 (US
Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal
Opportunity Employer and, in the US, we adhere to Affirmative
Action principles. This ensures that all qualified applicants will
receive equal consideration for employment without regard to race,
color, national origin, religion, sex, pregnancy, marital status,
sexual orientation, gender identity/expression, age, disability,
genetic information, military service, covered/protected veteran
status or any other federal, state or local protected class. At
GSK, the health and safety of our employees are of paramount
importance. As a science-led healthcare company on a mission to get
ahead of disease together, we believe that supporting vaccination
against COVID-19 is the single best thing we can do in the US to
ensure the health and safety of our employees, complementary
workers, workplaces, customers, consumers, communities, and the
patients we serve. GSK has made the decision to require all US
employees to be fully vaccinated against COVID-19, where allowed by
state or local law and where vaccine supply is readily available.
The only exceptions to this requirement are employees who are
approved for an accommodation for religious, medical or
disability-related reasons. Important notice to Employment
businesses/ Agencies GSK does not accept referrals from employment
businesses and/or employment agencies in respect of the vacancies
posted on this site. All employment businesses/agencies are
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information, please visit GSK's Transparency Reporting For the
Record site.PDN-9577ef3c-53e2-4731-9131-7fb9b77ecfe5
Keywords: GlaxoSmithKline, Rockville , Clinical Research and Development Lead (CRDL), CMV Vaccine, Healthcare , Rockville, Maryland
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