Head of BioLife Medical Affairs

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Job Description

OBJECTIVES/PURPOSE

• OverseeingallBiolife(BPS)MedicalAffairs.
• AssuremedicalcomplianceattheBiolifeplasmapheresisfacilitieslocatedintheUnited States(US).
• ProvidemedicalexpertisetovariousBPSdepartmentssuchasOperations,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 BPS Center 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.
• ParticipateonPPTAMedicalDirectorPolicyCommitteeand applicablesubcommittees.
• 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/Functional (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-makingand 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

For Location:

U.S. Base Salary Range:

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.

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