Head of BioLife Medical Affairs
Takeda
- Bannockburn, IL
- Permanent
- Full-time
- 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).
- 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.
- 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.
- Ability to manage a diverse function with a team with a broad range of skills.
- Demonstrate a willingness to adopt new technologies and influence the team to do the same.
- Demonstrate strong leadership and interpersonal skills.
- Ability to make complex medical decisions on quickly emerging issues.
- 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.
- 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.
- 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.
- 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