Senior Director, GRA Pharmaceuticals-TAK-279
Posted on: November 20, 2023
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About the role:
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 in order to bring life-changing
therapies to patients worldwide.
Join Takeda as a Senior Director, GRA Pharmaceuticals- Small
Molecule where you will e stablish collaboration with Global CMC
teams and leadership through networks and enable CMC regulatory
team's success in meeting goals/objectives. You will also influence
changing regulations and guidance documents; interface with outside
regulatory agencies and trade associations and acts as an advisor/
liaison to senior management to plan, evaluate and recommend
How you will contribute:
- Leads the Early Development Pharmaceuticals GRA CMC TAK-279
regulatory team in the development and implementation of global CMC
regulatory strategies during development ,commercialization and
post approval LCM stages
- Combines knowledge of scientific, regulatory and business
issues to ensure the regulatory filings are of high quality and
right first time.
- Maintain up-to-date knowledge and expertise of relevant CMC and
quality guidelines and regulations and establishes mechanisms to
communicate them to relevant stakeholders, thereby driving
prospective and proactive implementation.
- Globally influences and is generally considered a key opinion
leader and resource within Takeda and externally with stakeholders
in HA and in Industry.
- Responsible for demonstrating Takeda leadership behaviors.
Serve as a member of the GRA-CMC Pharmaceuticals Leadership team,
giving input to key strategic, portfolio, human capital and
- Provides leadership of GRA CMC Pharmaceuticals - TAK-279
franchise, and in conjunction with direct reports, manages
resources, establish a CMC RA strategy and collaborate with
stakeholders in global Reg CMC and across the enterprise to deliver
- Inconjunction with members of the team, develop high quality
clinical, commercialization and LCM submissions, using proactive
regulatory CMC strategies and submit them as planned.
- 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/associtions, 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
- 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
- Leads or plays a key role on the relevant internal Takeda
Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry with
significant experience in regulatory filings across various stages
of development. Ability to simplify and streamlineclinical,
commercialization and LCM submissions and increase the efficiency
of the team through standardization and creation of templates,
- Expert knowledge of API and product development, registration
and maintenance regulations with experience in championing
innovation in technical areas.
- Experience in operating in a multi-disciplinary drug
development environment, including working within and managing
across an international exposure.
- Demonstrated track record of successful interactions with FDA,
EMA, and other global health authorities to enable informed
decision making that are targeted to provide the skeleton from
commercialization stage submissions
- Understanding of scientific principles and regulatory
requirements relevant to global drug development and regulatory
- Knowledge and understanding of relevant emerging regulations
and related processes
- Knowledge of diverse therapeutic areas and recent innovative
- Possess outstanding leadership and interpersonal skills with a
management style which encourages open expressions of ideas,
opinions, and a full discussion of differing points of view. Sound
judgment and independent initiative.
- Ensures that every employee knows what is expected of their
role and what it takes to be successful. Helps employees grow
through challenging assignments so they may realize their full
- Excellent communicator, able to persuasively convey both ideas
and data, verbally and in writing
- Proven skills as an effective team player who can engender
credibility and confidence within and outside the company
- Ability to distil complex issues and ideas down to simple
- Executive leadership presence and confidence
Decision-making and Autonomy
- Ability to collaborate with and achieve results through others;
builds strong and sustainable relationships and interact within all
levels of the organization
- A member of Global CMC RA Pharmaceuticals Leadership team and
an extended/ad-hoc member of the GRA CMC leadership team and
related councils across the enterprise
- Ad-hoc participation in senior leadership teams as needed
- Responsible for internal processes and systems to support
external representation are implemented and effectively
- Effectively navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace
- Demonstrated ability to succinctly translate and effectively
communicate the potential impact of significant and complex
- Effectively represent Takeda in high-level negotiations with
the ability to resolve conflict in a constructive manner
- Ability to build strong partnerships and drive role clarity
with other interfacing Takeda functions, including but not limited
to GMS, GQ, Pharmaceutical sciences, clinical pharmacology and the
- A solid grasp of industry, scientific, and regulatory trends to
leverage innovations to make Takeda a model for the industry
- Visionary and forward thinking with the ability to influence
and effectively drive organizational change and continuous
- Comfortable challenging the status quo and bringing forward
- Ability to take risks implementing innovative solutions,
accelerating time to market
- Ability to work in a global ecosystem (internal and external)
with a high degree of complexity
- Ability to manage assignments and effectively deliver all
expected deliverables in an organized and a timely manner and
proactively communicate changes in pre-established goals and
- Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines,
or related discipline.
- Languages: Fluent in English (oral and written); additional
- Minimum of 15 years of experience within regulatory agencies or
the Pharmaceutical Industry including significant leadership
experience in Regulatory Sciences
- 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. CPC,
EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint
regulator/industry initiatives (e.g. ICH).
- Strong communication, collaboration, negotiation, problem
solving and interpersonal skills. Has a proven track record of
working across regulator/industry boundaries to find common
solutions and drive positive impact and benefits for patients.
- High organization awareness (e.g. interrelationship of
departments, business priorities), including significant experience
working cross-functionally and in teams.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development
of novel specialty pharmaceuticals and best in class patient
support programs. Takeda is a patient-focused company that will
inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating
careers, encourages innovation, and strives for excellence in
everything we do. We foster an inclusive, collaborative workplace,
in which our teams are united by an unwavering commitment to
deliver Better Health and a Brighter Future to people around the
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $194,600 to $278,000 based on candidate
professional experience level. Employees may also be eligible for
Short-term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience.
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.
Keywords: Takeda, Boston , Senior Director, GRA Pharmaceuticals-TAK-279, Executive , Boston, Massachusetts
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