Associate Director DMPK Project Representative
Company: Disability Solutions
Location: Cambridge
Posted on: May 3, 2024
Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more:
careers.bms.com/working-with-us .Scientific Associate Director,
DMPK Project Representative Challenging. Meaningful. Life-changing.
Those aren't words that are usually associated with a job. But
working at Bristol Myers Squibb is anything but usual. Here,
uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in
cell therapy, this is work that transforms the lives of patients,
and the careers of those who do it. You'll get the chance to grow
and thrive through opportunities uncommon in scale and scope,
alongside high-achieving teams rich in diversity. Take your career
farther than you thought possible.Within the Pharmaceutical
Candidate Optimization (PCO) organization at BMS, the Development
DMPK Team provides ADME (absorption, distribution, metabolism, and
excretion) and PK (pharmacokinetics) support for all pipeline
assets throughout clinical development, from candidate nomination
through registration and lifecycle management. The Dev DMPK team is
responsible for characterizing the ADME properties, and
drug-interaction potential of drug candidates. Working closely with
drug safety and clinical pharmacology, Dev DMPK plays a critical
role in IND submissions and marketing authorization applications.
We utilize our deep expertise in ADME and PK to collaborate with
peer R&D functions to identify and solve issues, enable
clinical development and successful marketing authorizations across
the globe. PCO is looking for a Scientific Associate Director to
join the Dev DMPK group that is an expert in ADME and
pharmaceutical drug development of protein therapeutics and small
molecule drugs. In this role, you will represent the Dev DMPK
function on cross-functional development project teams; oversee
developmental drug disposition metabolism and non-clinical
pharmacokinetics activities of multiple projects; be responsible
for preparation of regulatory dossier/responses; and assist in
developing strategy for the group. You will collaborate with
discovery team in PCO, Toxicology, Biopharmaceutic, Bioanalytical,
Clinical Pharmacology to ensure transition from discovery to
First-In-Human and address drug development issues. Key
Responsibilities In the role, the ideal candidate:
- Represents Dev DMPK on cross-functional development project
teams for biologics and small molecule therapeutics, including
preparing project strategies and development plans.
- Oversees internal and outsourced nonclinical drug metabolism
and PK activities on multiple projects, including study design,
data interpretation, report preparation.
- Writes and critically reviews nonclinical submission documents
such as CTD sections for INDs and NDAs/BLAs, Investigator
Brochures, briefing books, DSUR, etc. to support clinical trials
and global drug registrations. Interact s with regulatory
authorities to address questions as needed.
- Support clinical assets for all ADME and PK related inquiries
and activities.
- Assists in guiding department strategy. Supervising and/or
mentoring junior scientists may also be required. Basic
Qualifications: Bachelor's Degree with 12+ years of academic and /
or industry experience OR Master's Degree with 10+ years of
academic and / or industry experience OR Ph.D. or equivalent
advanced degree in the Life Sciences with 8 + years of academic and
/ or industry experience. Plus 4 years of leadership experience.
Preferred Qualifications
- PhD degree in pharmaceutics, biochemistry, chemistry, biology
or related fields, and 8+ or more years of relevant drug discovery
and development experience within the pharmaceutical Plus 4+ years
of leadership experience
- Experience with preclinical PK and PK/PD modeling for biologics
is a plus.
- Extensive expertise in drug disposition and small molecule
therapeutics , including understanding of in vitro and in vivo
techniques used to characterize ADME properties of drug candidates,
and factors that impact large molecule PK (TMDD and ADA) .
- A thorough understanding of drug development of biologics and
small molecule therapeutics
- Working knowledge of bioanalysis.
- Working knowledge of PK/PD concepts and models, as well as
proficiency in human PK and dose prediction.
- Effective at independently working with interdisciplinary
project teams, including developing ADME strategies and
implementing drug development plans.
- Understanding of regulatory requirements in the areas of drug
metabolism, drug-drug interactions, bioanalysis, toxicology, and
clinical pharmacology.
- Experience preparing drug metabolism reports and regulatory
submission documents.
- Experience overseeing studies performed internally or at
external CROs.
- Strong written and verbal communication skills. If you come
across a role that intrigues you but doesn't perfectly line up with
your resume, we encourage you to apply anyway. You could be one
step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single
vision as inspiring as Transforming patients' lives through
science--- , every BMS employee plays an integral role in work that
goes far beyond ordinary. Each of us is empowered to apply our
individual talents and unique perspectives in an inclusive culture,
promoting diversity in clinical trials, while our shared values of
passion, innovation, urgency, accountability, inclusion and
integrity bring out the highest potential of each of our
colleagues.On-site Protocol BMS has a diverse occupancy structure
that determines where an employee is required to conduct their
work. This structure includes site-essential, site-by-design,
field-based and remote-by-design jobs. The occupancy type that you
are assigned is determined by the nature and responsibilities of
your role: Site-essential roles require 100% of shifts onsite at
your assigned facility. Site-by-design roles may be eligible for a
hybrid work model with at least 50% onsite at your assigned
facility. For these roles, onsite presence is considered an
essential job function and is critical to collaboration,
innovation, productivity, and a positive Company culture. For
field-based and remote-by-design roles the ability to physically
travel to visit customers, patients or business partners and to
attend meetings on behalf of BMS as directed is an essential job
function. BMS is dedicated to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace accommodations/adjustments and ongoing support
in their roles. Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/
eeo -accessibility to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your
area.Any data processed in connection with role applications will
be treated in accordance with applicable data privacy policies and
regulations.
Keywords: Disability Solutions, Revere , Associate Director DMPK Project Representative, Executive , Cambridge, Massachusetts
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