Director Development DMPK
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 .Director, Development DMPK
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.When
you join BMS, you are joining a diverse, high-achieving team united
by a common mission.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 Development DMPK team is
responsible for characterizing the ADME properties, and
drug-interaction potential of drug candidates. Working closely with
drug safety and clinical pharmacology, Development 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
Director to join the Development DMPK group that is an expert in
ADME and pharmaceutical drug development of protein therapeutics
and small molecule drugs. The successful candidate can work from
either our Lawrenceville, NJ or Cambridge, MA sites. In this role,
you will represent the Development 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, Biopharmaceutics, 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 Development 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 15+ years of academic and / or industry
experience OR
- Master's Degree with 12+ years of academic and / or industry
experience
- OR
- PhD or equivalent advanced degree in the Life Sciences with 8+
years of academic and / or industry experience, with 6+ years of
leadership experience.
- Extensive expertise in drug disposition and PK of biologics 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. Preferred
Qualifications
- PhD degree in pharmaceutics, biochemistry, chemistry, biology
or related fields, and 10 or more years of relevant drug discovery
and development experience within the pharmaceutical industry.
- 6+ years of leadership experience.
- Experience with preclinical PK and PK/PD modeling for biologics
is a plus. 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, Waltham , Director Development DMPK, Executive , Cambridge, Massachusetts
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