Vice President, GRA CMC, Biologics and Advanced Therapy Medicinal Products (ATMP)
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: April 17, 2024
|
|
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda'sPrivacy Notice and Terms of Use. I further attest that
all information I submit in my employment application is true to
the best of my knowledge.
Job Description
At Takeda, we are a forward-looking, world-class R&D
organization that unlocks innovation and delivers transformative
therapies to patients. By focusing R&D efforts on three
therapeutic areas and other targeted investments, we push the
boundaries of what is possible to bring life-changing therapies to
patients worldwide.
How you will contribute:
Vice President, Biologics and ATMP is a critical role within GRA,
Takeda R&D, responsible for managing a complex organization
that spans two critical modalities. This role is crucial for the
future of Takeda as it oversees the entire Takeda portfolio for
biologics and ATMP, including cell and gene therapy products. The
individual in this role will collaborate with multiple stakeholders
in R&D, GRA, GMS, Global Quality, and Commercial to develop
innovative strategies for the management of development products,
regulatory conformance, and pipeline management.
Key Responsibilities:
Manage critical portfolios for biologics and ATMP, ensuring the
health and success of these portfolios for the future of
Takeda.
Collaborate with stakeholders in R&D, GRA, GMS, Global Quality,
and Commercial to develop innovative strategies for the management
of development products.
Develop processes, systems, and infrastructure to assure regulatory
conformance prospectively and retrospectively for products in the
post-approval space.
Work closely with colleagues in quality and commercial
organizations to manage pipeline products and bring current
products to industry standards.
Represent CMC and GRA on key governance committees and play a
critical role in driving the organization towards innovative
approaches for the adoption and registration of new technologies
and molecules.
Lead and mentor senior individuals with varying backgrounds,
enabling them to hire, mentor, and develop capable individuals who
can represent the organization internally and externally.
Interface with senior management, serving as the primary conduit
for reporting performance against critical activities and as the
voice of senior management to the team.
Resolve conformance challenges with ERT programs and serve as the
liaison with senior management on the issue.
ACCOUNTABILITIES
Responsible for demonstrating Takeda leadership behaviors. Serve as
a member of the GRA-CMC Leadership team, giving input to key
strategic, portfolio, human capital and financial decisions.
Provides leadership of GRA CMC Biologics & ATMP regulatory team and
in conjunction with direct reports, manages resources, establish a
vision, and collaborate with stakeholders in global Reg CMC and
across the enterprise to deliver against them.
In conjunction with members of the team, develop as well as oversee
development (including updates) and communication of proactive
regulatory CMC strategies to global CMC regulatory teams and
stakeholders in a timely manner
Builds and manages relationships through active partnering with key
internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and
external stakeholders (Health authorities, Industry
counterparts/associations, academia). Relationship management and
constructive partnering with Health Authorities and relevant
industry organizations to drive Takeda position and influence
scientific approach and thought process to CMC topics.
Ensures team effectiveness in working across a very complex matrix
environment in GRA with CMC RA project leads and other GRA
sub-functions, as needed to ensure effective strategies are
developed and project execution is on target.
Build and maintain communication strategy and platform for all
staff across the organization. Responsible for timely dissemination
of regulations, guidelines and data to staff and stakeholders via
team sites or intranet. Actively engage and influence organization
to think proactively and utilize science and risk-based approach to
product development and LCM activities.
Contribute to creating and communicating an employment culture and
values which attract, retain, and develop the most effective
people.
Ensure compliance with all applicable Takeda SOPs, local and
international regulations, and industry best-practice.
Represents, as required, the regulatory function in the evaluation
of new product opportunities internally and externally. Leads or
plays a key role on the relevant internal Takeda governance
committees
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or
related discipline.
Languages: Fluent in English (oral and written); additional
languages desirable
Minimum of 20 years of experience within regulatory agencies or the
Pharmaceutical Industry including significant leadership experience
in Regulatory Sciences
Strong leadership skills with the ability to manage ambiguity and
lead teams in high-stress situations. Has a proven track record of
working across regulator/industry boundaries to find common
solutions and drive positive impact and benefits for patients.
Excellent communication skills, with the ability to communicate
concisely and clearly across all levels of the organization.
Proven ability to collaborate with stakeholders internally and
externally, including regulatory authorities.
Experience in biologics and ATMP, with a deep understanding of the
industry and regulatory landscape.
Strong strategic thinking and problem-solving skills, with the
ability to make informed decisions using risk-based approaches.
Significant understanding and track record in dealing with
international regulations and policies setting processes of major
regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
Actively engaged in major industry associations (e.g. EFPIA, BIO,
PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry
initiatives (e.g. ICH).
High organization awareness (e.g. interrelationship of departments,
business priorities), including significant experience working
cross-functionally and in teams.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider
the next step in your career. We are committed to equitable pay for
all employees, and we strive to be more transparent with our pay
practices.
For Location:
Boston, MAU.S. Base Salary Range:
$252,000.00 - $396,000.00The estimated salary range reflects an
anticipated range for this position. The actual base salary offered
may depend on a variety of factors, including the qualifications of
the individual applicant for the position, years of relevant
experience, specific and unique skills, level of education
attained, certifications or other professional licenses held, and
the location in which the applicant lives and/or from which they
will be performing the job. The actual base salary offered will be
in accordance with state or local minimum wage requirements for the
job location.
U.S. based employees may be eligible for short-term and/or
long-termincentives. U.S.based employees may be eligible to
participate in medical, dental, vision insurance, a 401(k) plan and
company match, short-term and long-term disability coverage, basic
life insurance, a tuition reimbursement program, paid volunteer
time off, company holidays, and well-being benefits, among others.
U.S.based employees are also eligible to receive, per calendar
year, up to 80 hours of sick time, and new hires are eligible to
accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce
and providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by law.
Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time--s-p-m1--
By applying, you consent to your information being processed by
SonicJobs and transmitted to the Employer.
See Takeda Pharmaceutical Terms of Use at
https://www.takeda.com/terms-of-use/ and Privacy Policy at
https://www.takeda.com/privacy-notice/ and SonicJobs Privacy Policy
at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at
https://www.sonicjobs.com/us/terms-conditions
Keywords: Takeda Pharmaceutical, Passaic , Vice President, GRA CMC, Biologics and Advanced Therapy Medicinal Products (ATMP), Executive , Jersey City, New Jersey
Click
here to apply!
|