Vice President, GRA CMC, Biologics and Advanced Therapy Medicinal Products (ATMP)
Company: Takeda
Location: Boston
Posted on: April 15, 2024
Job Description:
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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, MA
U.S. Base Salary Range:
$252,000.00 - $396,000.00
The 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 e mployee s may be eligible for s hort - t erm and/ or l
ong- t erm incentive s . 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, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda, Somerville , Vice President, GRA CMC, Biologics and Advanced Therapy Medicinal Products (ATMP), Healthcare , Boston, Massachusetts
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