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Head of BioLife Medical Affairs - Evanston, United States - Biolife Plasma Services
Description
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 DescriptionOBJECTIVES/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 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.
Participate on PPTA Medical Director Policy 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 ASPECTSTechnical/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.
LeadershipAbility 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.
InteractionAbility 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.InnovationEmbrace innovation while ensuring donor safety.
ComplexityAbility 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 MedicineAt 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, IllinoisMORE 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-HybridBioLife 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:
Bannockburn, ILU
S Base Salary Range:
$256, $402,600.00The 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 employees may be eligible for short-term and/or long-term incentives. 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 StatementTakeda 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.
LocationsBannockburn, ILWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
