GMA Medical Unit Lead: PDT RAID
Company: Takeda
Location: Cambridge
Posted on: November 20, 2023
Job Description:
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Job Description
OBJECTIVES/PURPOSE
- Leads development and execution of multi-year global medical
strategy for Rare Autoimmune Diseases (RAID), appropriately aligned
with overall strategy and incorporating PDT R&D functional
strategies (e.g. clinical, regulatory, GEO, safety,
compliance)
- Leads the Global RAID Medical team for the product/disease
area
- Responsible for development and in-year implementation of the
global medical plans in collaboration with the regional and LOC
partners
- Serves as the global expert within PDT in support of the
product/disease area including the respective expanded access
strategy
ACCOUNTABILITIES
- Leads the Global RAID Medical team for the product/disease
area
- Leads development and execution of multi-year global medical
strategy for the specified Rare Autoimmune Diseases(RAID):
- scientific communicaiton and education strategy e.g.
publications strategy, congress strategy, HCP interaction strategy,
and the scientific communication platform for the disease area /
brand(s);
- evidence generation: developing integraed evidence generation
strategy, phase IV studies, registries, investigator initated
research, participate in designing clinical development strategy
and and study designs;
- External Expert engagement: HCP interaction strategy,
Scientific societies interaction;
- Internal capacity building: sceintific training strategy and
execution appropriately aligned with overall strategy and
incorporating R&D and cross-functional strategies (e.g.
clinical, regulatory, GEO, safety, compliance)
- Acts as a senior company representative interacting with
external scientific leaders, patient organizations, scientific
societies and/or regulatory authorities as appropriate
- Responsible for development and in-year implementation of the
global medical plans supporting global medical strategy in
collaboration with the regional and LOC partners (e.g.
publications, medical communications, medical training, evidence
generation) Input to development and management of the PDT R&D
medical budget, responsibility for the product/disease area medical
budget
- Establishes appropriate strategic partnerships with centers of
excellence and health care professionals (HCPs) in areas of
scientific interest
- Collaborates with Legal, Compliance and Regulatory to ensure
proper and ethical interactions between PDT Global Medical Affairs
personnel and external stakeholders
- Contribute to PDT Global Medical Affairs Strategy by providing
deep medical/ clinical expertise in the particular disease
area
- Planning, designing and managing PDT global medical Advisory
Boards as appropriate
- Providing medical review and approval of Investigator Initiated
Research (IIR) proposals and other grants through the grant
approval process
- Leading design and execution of medical affairs
company-sponsored and collaborative studies (phase IIIb/IV, disease
registries, observational, noninterventional, epidemiological,
outcomes surveys, etc.) in close collaboration with Therapeutic
Area Unit representatives and Global Clinical Operations
- Monitor and communicate progress against medical plan; propose
and initiate initiatives as need to adjust to disease area
requirements
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry and
Medical Affairs (e.g. Publications, Med Info, Knowledge systems,
evidence generation, etc.)
- Global medical affairs expertise with demonstrated strong
ability for collaboration and team
- leadership; experience leading and working with cross-cultural
teams
- Ability to think strategically from a medical perspective about
how to medically appropriately support the growth of a
medication
- 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
Leadership
- Demonstrated ability to work in a global environment, across
functions, regions and cultures
- Enterprise level leadership with the ability to inspire,
motivate and drive results
- Leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviours for the organization
- Demonstrated business acumen
- Ability to successfully influence and negotiate across and
outside of the organization
Decision-making and Autonomy
- Demonstrated business acumen
- Excellent decision-making capabilities, ability to make complex
decisions that impact the department/PDT R&D
- Ability to incorporate feedback and ensure decisions are made
swiftly to yield flawless execution
Interaction
- Effectively navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace
- Ability to effectively implement PDT R&D's partnership
strategy
- Ability to build strong partnerships and drive role clarity
with other interfacing Takeda functions, including but not limited
to GMA CoE, GPSE, LOC, Market Access, GOR
Innovation
- Forward thinking with the ability to influence and effectively
drive organizational change and continuous innovation
- Comfortable challenging the status quo and bringing forward
innovative solutions
- Ability to take risks implementing innovative solutions,
accelerating time to market
- Ability to seek diverse input from multiple constituents and
stakeholders to drive innovative solutions
- Accountable for designing and implementing vision and strategy
for designated scope
Complexity
- Ability to distil complex issues and ideas down to simple
comprehensible terms
- Ability to work in a global ecosystem (internal and external)
with a significant degree of complexity
- Breadth of knowledge required across therapeutic areas,
indications, and/or modalities
- Experience operating in a multi-disciplinary drug development
environment including international experience and exposure to a
variety of therapeutic areas.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- A medical degree (MD), PharmD or country specific equivalent is
required
- Clinical experience in neurology is required, in Immunology is
a plus
- Experience in launching in rare disease (i.e. neurology and/or
immunology) is required
- > 5 years of experience in pharmaceutical medicine/medical
affairs
- > 3 Years experience in global/international medical affairs
is required
- Experience leading teams is required
- Experience in field-based roles (e.g. Medical Director, Medical
Science Liaison) is a plus
- Experience in clinical development is a plus
ADDITIONAL INFORMATION
- Availability to travel up to 30% of time
- Some activities may call for early or late meetings and
attendances at scientific meetings on holidays and weekends
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
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
contributions
- Family Planning Support
- Flexible Ways of Working
- 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
world.
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply
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
Cambridge, MA
AUT - Vienna - K--rntner Ring
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda, Cambridge , GMA Medical Unit Lead: PDT RAID, Healthcare , Cambridge, Massachusetts
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