Head, Translational Biomarkers, Preclinical and Translational Development
Company: bluebird bio
Location: Cambridge
Posted on: April 8, 2021
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Job Description:
Head, Translational Biomarkers, Preclinical and Translational
Development On January 11, 2021, we announced our intent to
separate our severe genetic disease and oncology businesses into
differentiated and independent publicly traded companies. We will
retain focus on severe genetic disease (SGD) and will launch our
oncology business ("Oncology Newco") as a new entity, with the
completed transition expected by the end of 2021. ABOUT THE NEST At
bluebird, only two things matter - patients and our people. When
you join the nest, you're not just landing a new gig, you become a
part of a flock that's soaring to new heights. We're 1100+ doers,
thinkers and collaborators across the globe with a strong sense of
our values and our purpose. Our innovation and sustainability are
rooted in the diversity of our teams and results are achieved
through cooperation and the incorporation of multiple points of
view. This is personal and we approach every challenge with radical
care. The time is now to rise up and recode the science, the
systems, and the status quo. ABOUT THE FLOCK Preclinical and
Translational Development (PTD) flock is looking to hire an
experienced, Director level leader to head the Translational
Biomarker group in our new Oncology Company. The candidate will be
leading the bioanalytical lab and clinical lab operations that work
on oncology programs from preclinical development through IND and
beyond. The Translational biomarker group works very closely with
other groups within PTD, Research, CMC and clinical development
organization, all working towards the overall mission of providing
transformative therapies to our cancer patients. This role requires
the writing and reviewing of preclinical and clinical biomarker
sections in regulatory documents, including INDs, MAAs, and BLAs.
Success in the role will depend on collaboration across Research,
Regulatory, QA, Vendor Management, Research, IT, CMC, and external
vendors to develop and implement processes and standards and to
develop regulatory filings. Alignment of the conduct and reporting
of bioanalytical testing with Good Clinical Practice (GCP) as well
as FDA, EMA, ICH and all other applicable regulatory requirements
is also a critical function of the role. --HOW YOU'LL FLY The
Preclinical and Translational Development (PTD) team works with
bluebird bio's Research (Oncology), Clinical, CMC and Regulatory
teams to develop robust target liability assessment, pharmacology
and toxicology (in vitro and in vivo), and translational biomarker
data that allows accelerated transition from the bench to the
clinic, from discovery through IND, late-stage clinical development
and licensure. In doing so, we continuously strive towards our
mission to bring curative therapies to our patients. As an/a
Translational Biomarker bird reporting to the Head of PTD,--you'll
help to bring more patients their bluebird days by:
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(opportunities, exciting news, etc.) from us? --*
U.S. Equal Opportunity Employment Information (Completion is
voluntary) Individuals seeking employment at bluebird bio are
considered without regards to race, color, religion, national
origin, age, sex, marital status, ancestry, physical or mental
disability, veteran status, gender identity, or sexual orientation.
You are being given the opportunity to provide the following
information in order to help us comply with federal and state Equal
Employment Opportunity/Affirmative Action record keeping,
reporting, and other legal requirements. Completion of the form is
entirely voluntary. Whatever your decision, it will not be
considered in the hiring process or thereafter. Any information
that you do provide will be recorded and maintained in a
confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity
Definitions If you believe you belong to any of the categories of
protected veterans listed below, please indicate by making the
appropriate selection. As a government contractor subject to
Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we
request this information in order to measure the effectiveness of
the outreach and positive recruitment efforts we undertake pursuant
to VEVRAA. Classification of protected categories is as follows: A
"disabled veteran" is one of the following: a veteran of the U.S.
military, ground, naval or air service who is entitled to
compensation (or who but for the receipt of military retired pay
would be entitled to compensation) under laws administered by the
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released from active duty because of a service-connected
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the three-year period beginning on the date of such veteran's
discharge or release from active duty in the U.S. military, ground,
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authorized under the laws administered by the Department of
Defense. An "Armed forces service medal veteran" means a veteran
who, while serving on active duty in the U.S. military, ground,
naval or air service, participated in a United States military
operation for which an Armed Forces service medal was awarded
pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB
Control Number 1250-0005 Expires 05/31/2023 Voluntary
Self-Identification of DisabilityWhy are you being asked to
complete this form? We are a federal contractor or subcontractor
required by law to provide equal employment opportunity to
qualified people with disabilities. We are also required to measure
our progress toward having at least 7% of our workforce be
individuals with disabilities. To do this, we must ask applicants
and employees if they have a disability or have ever had a
disability. Because a person may become disabled at any time, we
ask all of our employees to update their information at least every
five years. Identifying yourself as an individual with a disability
is voluntary, and we hope that you will choose to do so. Your
answer will be maintained confidentially and not be seen by
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decisions. Completing the form will not negatively impact you in
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past. For more information about this form or the equal employment
obligations of federal contractors under Section 503 of the
Rehabilitation Act, visit the U.S. Department of Labor's Office of
Federal Contract Compliance Programs (OFCCP) website at
www.dol.gov/ofccp . How do you know if you have a disability? You
are considered to have a disability if you have a physical or
mental impairment or medical condition that substantially limits a
major life activity, or if you have a history or record of such an
impairment or medical condition. Disabilities include, but are not
limited to:
Keywords: bluebird bio, Cambridge , Head, Translational Biomarkers, Preclinical and Translational Development, Other , Cambridge, Massachusetts
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