Head of BioLife Medical Affairs - Chicago, United States - Takeda

Description

As a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda's Plasma-Derived Therapies (PDT) Business Unit is dedicated to transforming the lives of patients worldwide who rely on these lifesaving and life-sustaining therapies.

With an 80-year legacy of developing treatments for rare and complex chronic diseases, we thrive on innovation, offering a broad, differentiated portfolio of more than 20 plasma medicines with integrated care solutions to patients in more than 80 countries.

Powered by ~ 17,000 Takeda employees, our ~230 high-quality BioLife donation centers, a dedicated R&D team, and eight world-class plasma manufacturing facilities, we are unleashing data, digital and technology to transform our end-to-end operations and set new industry standards.

This enables us to innovatively and sustainably meet the growing and changing needs of patients, our people, and our planet, today and in the future.

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's Privacy 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

OBJECTIVES/PURPOSE
Overseeing

all

Biolife

(
BPS
)

Medical

Affairs

.
Assure

medical

compliance

at

the

Biolife

plasmapheresis

facilities

located

in

the

United States

(US)

.
Provide

medical

expertise

to

various


BPS
departments

such

as

Operations

,

Legal

,

Regulatory

,

Quality

Assurance, IT, Marketing and Environmental, Health and Safety (EHS).

ACCOUNTABILITIES
Provide medical and scientific direction to BPS-US facilities on medical matters associated with donor eligibility, safety and plasma suitability.
Interact with and provide support to the
BPSCenter Physicians and Medical Supervisors on specific medical issues as needed.
Develop and implement medical policies and procedures to support business, legal and regulatory needs including but not limited to donor advisement and medical affairs guidance

(MAG)

.
Responsible for Center Physician and Medical Support Specialist (MSS) training

programs

.
Responsible for

oversight of the

development and maintenance processes for the Center Physician hiring, contracts and terminations.
Provide medical guidance on donor post-donation information and lookback

cases

.
Review donor reactions and track and trend quarterly, or more frequently, as needed, and take appropriate action as necessary.
Participate

on


PPTA
Medical

Director

Pol

i

cy

Committee

and applicable

subcommittees

.

Provide medical expertise to the EHS department on employee vaccination programs (e.g., Hepatitis B, flu, etc.), blood borne pathogen exposure procedures and any other applicable programs.

Interface with EHS to maintain compliance with OSHA and other regulatory agencies, and act as the principal investigator for selected IND studies performed in BPS-US

facilities

.

DIMENSIONS AND

ASPECTS
Technical/Functiona

l

(Line)

Expertise

Physician who is able to apply medical expertise to the plasmapheresis business to ensure donor safety across a broad range of areas that can impact donor and/or plasma safety, such as medical devices and IT systems.

Leadership
Ability to manage a diverse function with a team with a broad range of

skills

.
Be results

oriented

.
Demonstrate a willingness to adopt new technologies and influence the team to do the

same

.
Demonstrate strong leadership and interpersonal

skills.
Decision-making

and

Autonomy
Ability to make complex medical decisions on quickly emerging

issues

.
Interaction

Ability to interact with MSSs, CPs, management staff and senior leadership to provide input on decisions that will impact donor safety.

Ability to explain rationale for medical decision making to Biolife leadership and external regulatory authorities.
Provide a voice to the Biolife positions to the
PPTA

MDPC
.
Embrace innovation while ensuring donor

safety

.
Complexity

Ability to engage with all levels of the organization on complex decisions that impact donor safety such as new technology, FDA requirements and emerging medical trends and risk.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential:
M

.

D

.

or D.O. degree, with medical licensure in the state of

residence

.
At least three years of medical practice

experience

related to Transfusion Medicine
At least three years '

experience in plasma or whole blood industry .
At least two years managerial experience in the industry (essential )

.
Knowledge of US FDA and EU regulations regarding plasma donor suitability and deferral criteria desirable.

ADDITIONAL INFORMATION
Position will be located in Bannockburn, Illinois

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.
#Li-Hybrid
BioLife Compensation and Benefits Summary
We understand compensation is

an important factor

as you consider the next step in your career.

W

e are committed to

equitable

pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Bannockburn, IL

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's Privacy 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

OBJECTIVES/PURPOSE
Overseeing

all

Biolife

(
BPS
)

Medical

Affairs

.
Assure

medical

compliance

at

the

Biolife

plasmapheresis

facilities

located

in

the

United States

(US)

.
Provide

medical

expertise

to

various


BPS
departments

such

as

Operations

,

Legal

,

Regulatory

,

Quality

Assurance, IT, Marketing and Environmental, Health and Safety (EHS).

ACCOUNTABILITIES
Provide medical and scientific direction to BPS-US facilities on medical matters associated with donor eligibility, safety and plasma suitability.
Interact with and provide support to the
BPSCenter Physicians and Medical Supervisors on specific medical issues as needed.
Develop and implement medical policies and procedures to support business, legal and regulatory needs including but not limited to donor advisement and medical affairs guidance

(MAG)

.
Responsible for Center Physician and Medical Support Specialist (MSS) training

programs

.
Responsible for

oversight of the

development and maintenance processes for the Center Physician hiring, contracts and terminations.
Provide medical guidance on donor post-donation information and lookback

cases

.
Review donor reactions and track and trend quarterly, or more frequently, as needed, and take appropriate action as necessary.
Participate

on


PPTA
Medical

Director

Pol

i

cy

Committee

and applicable

subcommittees

.

Provide medical expertise to the EHS department on employee vaccination programs (e.g., Hepatitis B, flu, etc.), blood borne pathogen exposure procedures and any other applicable programs.

Interface with EHS to maintain compliance with OSHA and other regulatory agencies, and act as the principal investigator for selected IND studies performed in BPS-US

facilities

.

DIMENSIONS AND

ASPECTS
Technical/Functiona

l

(Line)

Expertise

Physician who is able to apply medical expertise to the plasmapheresis business to ensure donor safety across a broad range of areas that can impact donor and/or plasma safety, such as medical devices and IT systems.

Leadership
Ability to manage a diverse function with a team with a broad range of

skills

.
Be results

oriented

.
Demonstrate a willingness to adopt new technologies and influence the team to do the

same

.
Demonstrate strong leadership and interpersonal

skills.
Decision-making

and

Autonomy
Ability to make complex medical decisions on quickly emerging

issues

.
Interaction

Ability to interact with MSSs, CPs, management staff and senior leadership to provide input on decisions that will impact donor safety.

Ability to explain rationale for medical decision making to Biolife leadership and external regulatory authorities.
Provide a voice to the Biolife positions to the
PPTA

MDPC
.
Innovation
Embrace innovation while ensuring donor

safety

.
Complexity

Ability to engage with all levels of the organization on complex decisions that impact donor safety such as new technology, FDA requirements and emerging medical trends and risk.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential:
M

.

D

.

or D.O. degree, with medical licensure in the state of

residence

.
At least three years of medical practice

experience

related to Transfusion Medicine
At least three years '

experience in plasma or whole blood industry .
At least two years managerial experience in the industry (essential )

.
Knowledge of US FDA and EU regulations regarding plasma donor suitability and deferral criteria desirable.

ADDITIONAL INFORMATION
Position will be located in Bannockburn, Illinois

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.
#Li-Hybrid
BioLife Compensation and Benefits Summary
We understand compensation is

an important factor

as you consider the next step in your career.

W

e are committed to

equitable

pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Bannockburn, IL

U

S Base Salary Range:
$256, $402,600.00

The

estimated

salary

range reflects

an anticipated

range for this position

. T

he 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 incentiv

e

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

Bannockburn, IL

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
What makes a successful team member within PDT at Takeda?
Bold thinker
Systematic
Agile
At the iHUB, we focus on disruptive innovation within our patient ecosystem that not only focuses on the patients of today, but

creates the pathway

to meet the patients of tomorrow.

Nat Arlander - Head of the Plasma Innovation Hub in PDT
Our dedicated and specialized PDT R&D organization is uniquely positioned to support the entire patient experience. By challenging decades of established thinking and driving patient-centric innovations,

we have the opportunity to have a tremendous impact

on those who rely on plasma-derived therapies today and those who can benefit from them in the future.
Changing lives with plasma-derived therapies
Inclusion
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation

Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

Top Workplace
Top Workplace

Recognized for our culture and way of working, we're one of only 17 companies to receive Top Global Employer status for 2024.

Work-Life
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to

Four Key Imperatives

Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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