Director--Patient Centered Assessment - Remote US based
Company: Labcorp Drug Development - USA
Location: Gaithersburg
Posted on: March 20, 2023
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Job Description:
Director, Patient Centered Assessment Remote Job Description
Labcorp Drug Development seeks a renmote / home based senior-level
researcher who specializes in patient-reported outcomes and
clinical outcomes assessments to develop business, lead client
engagements and manage client relationships in our consulting
group. The Director leads expert teams (colleagues and clients) to
conduct scientifically robust qualitative and quantitative studies,
develop and validate COA measures, assist in implementing COAs in
clinical trials to measure patient relevant endpoints, develop and
implement FDA COA related strategy and develop publications and
present at scientific conferences. A specific background in COA
development and validation and application of COAs in clinical
trials is desired. This is a unique opportunity to work with
clients in a scientific consulting capacity and build and grow an
expert team, including: taking scientific responsibility for
project completion, applying regulatory knowledge/expertise;
attending meetings with clients, identifying opportunities for new
business; leading projects and overseeing project teams, budgets
and deliverables; developing and leading staff; and acting as
resource for scientific COA knowledge internally. Job
Responsibilities and skills: The candidate will be able to: Provide
scientific leadership including applying COA regulatory
knowledge/expertise with clients and internal colleagues Direct
project teams, setting expectations, guiding activities, managing
and mentoring staff Attend and lead client meetings for current and
new projects Prepare proposals and budgets (conceptualize, draft,
revise, supervise preparation of) in response to client
requirements Advise on best methods to address client and research
needs Manage their capacity and utilization across multiple
projects Participate in business development including capabilities
pitches and bid defenses Interact effectively with internationally
remote and culturally diverse colleagues Effectively coach and
mentor junior colleagues Produce deliverables (e.g. study
protocols, reports) of high scientific quality Present scientific
work in peer-reviewed journals and at professional meetings The
ideal candidate will have a solid understanding of advanced design
and analysis techniques used in both qualitative and quantitative
COA research, including ability to: Critically review literature,
COA measures and labels, conduct evidence gap analyses Develop COA
measures using qualitative and quantitative research methods Design
statistical analysis plans for COA endpoints in clinical trials
including estimation of meaningful within-patient change Analyze
and interpret data using advanced statistical methods Conduct
psychometric analyses using modern validity theory Advise clients
on regulatory strategy related to COAs used in medical product
development Recommend appropriate COA measures for inclusion in
clinical trial protocols. The candidate will offer experience in a
consulting or pharma/biotech environment and have experience in
clinical trial and observational study design, selection of COAs to
measure clinical trial endpoints, development of study protocols
and analysis plans, collection and analysis of qualitative and
quantitative data, and with COA measure development and evidence
generation to support labeling claims in the US and EU. The
candidate must possess skills in and experience consulting for
pharma and biotech clients and the ability to clearly communicate
both verbally and written. At Labcorp Drug Development, you can
make a difference by helping to deliver life-saving and
life-enhancing medicines to people around the world. Our commitment
to this mission has resulted in our impressive history of company
stability and growth. We've achieved these results by fostering a
work environment that encourages, develops and leverages our team's
capabilities. Labcorp Drug Development believes that their
best-in-class employees deserve first-class benefits. Labcorp Drug
Development offers an outstanding benefits package including
medical & dental insurance, tuition reimbursement, a 401(k) plan
with a generous company match, short and long-term disability, and
life insurance, all of which are effective on your first day of
employment! At Labcorp Drug Development, we help make the miracles
of medicine a reality. We offer opportunities to work on diverse,
challenging projects with bright, interesting colleagues while
building a flexible and rewarding career. There is no better time
to join us! Education/Qualifications The candidate will possess a
doctorate degree in a relevant field (e.g. psychology, educational
psychology, health services research). Experience The Director
should have at least 10 years of experience working with
biopharmaceutical and/or medical device companies and have: solid
understanding of advanced methods and analytic techniques used in
qualitative and quantitative research related to COA development
and validation experience interacting with regulatory agencies
related to COA labeling claims and evidence requirements. ability
to establish new and maintain existing client relationships people
management experience The Director is expected to travel to meet
with clients and must be able to work on evenings and weekends as
necessary to meet project schedules. EEO Employer LabCorp Drug
Development is committed to diversity in the workplace and is an
equal opportunity employer (Minority/Female/Individual with
Disability/Veteran/Sexual Orientation/Gender Identity). Your
confidentiality and privacy are important to us. Pay Range:
$165,000 - $195,000 USD Position may be eligible for bonus and RSU,
dependent on employee and company performance Benefits: All job
offers will be based on a candidate's skills and prior relevant
experience, applicable degrees/certifications, as well as internal
equity and market data. Regular, full-time or part-time employees
working 20 or more hours per week are eligible for comprehensive
benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K),
ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus
where applicable. For more detailed information, please click here
. As a leading contract research organization (CRO), Labcorp Drug
Development provides comprehensive drug development solutions for a
range of industries. Our services cover the preclinical, clinical
and post-market phases of drug development, the product life cycles
for medical device and diagnostics and development services paired
with regulatory support for the chemical testing and crop
protection industries. Labcorp Drug Development is a global leader
in nonclinical safety assessment, clinical trial testing and
clinical trial management services. Our unique perspectives are
based on decades of scientific, medical and regulatory expertise.
In July 2022, Labcorp announced its intention to spin off its
clinical development business as a separate public company, subject
to the satisfaction of certain customary conditions. Fortrea will
become the new brand identity for our Clinical Development business
in connection with the spin-off, which is expected in mid-2023. We
believe that the exceptional is possible when you have the right
partner, so we are looking for the right people to help build a
transformative force in Clinical Development. Labcorp is proud to
be an Equal Opportunity Employer: As an EOE/AA employer, Labcorp
strives for diversity and inclusion in the workforce and does not
tolerate harassment or discrimination of any kind. We make
employment decisions based on the needs of our business and the
qualifications of the individual and do not discriminate based upon
race, religion, color, national origin, gender (including pregnancy
or other medical conditions/needs), family or parental status,
marital, civil union or domestic partnership status, sexual
orientation, gender identity, gender expression, personal
appearance, age, veteran status, disability, genetic information,
or any other legally protected characteristic. We encourage all to
apply. For more information about how we collect and store your
personal data, please see our Privacy Statement .
Keywords: Labcorp Drug Development - USA, Washington DC , Director--Patient Centered Assessment - Remote US based, Executive , Gaithersburg, DC
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