Associate Medical Director, BioLife/PDT
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Job DescriptionThe Medical, Associate Director is responsible for overseeing clinical research and ensuring regulatory compliance. This role involves strategic planning, data interpretation, and guiding teams to align clinical trials with organizational goals. By managing complex trials and fostering a collaborative environment, this role contributes to Takeda's mission.
ACCOUNTABILITIES
- Provide medical and scientific direction to BPS-US facilities on medical matters associated with donor eligibility and plasma suitability.
- Interact with and provide support to the BPS Center Physicians, including hiring, training and determining donor eligibility.
- Review and assess current medical affairs guidance (MAG) to determine areas for improvement.
- Responsible for Center Physician and Medical Support Specialist (MSS) training programs.
- Responsible for development and maintenance processes for the Center Physician hiring, contracts and terminations.
- Provide medical guidance on donor post-donation information and lookback cases.
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
- Be results oriented.
- Demonstrate a willingness to adopt new technologies and influence the team to do the same.
- Demonstrate strong leadership and interpersonal skills.
- Global perspective with a demonstrated ability to work across functions, regions, and cultures
- Ability to identify potential challenges and opportunities and make recommendations
- Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
- Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization
- Invests in helping others learn and succeed
- Able to influence without authority at senior (TET/TET-1) level
- Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.
Decision-making and Autonomy
- Ability to make complex medical decisions on quickly emerging issues.
- Accountable for acting decisively and exercise sound judgment in making decisions with limited information
- Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
- Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
- Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution
- Develops executable plans and meets budget and deadlines
- Builds a culture of data driven decisions
Interaction
- Ability to interact with MSSs, CPs, management staff and senior leadership to provide input on decisons that will impact donor safety.
- Ability to explain rationale for medical decision making to BioLife leadership and external regulatory authorities.
- Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU
- Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
- Strong communicator, able to persuasively convey ideas verbally and in writing
- Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders
Innovation
- Embrace innovation while ensuring donor safety.
- Disruptive thinker with the ability to influence and change how PDT used data to make decisions and set priorities
- Continuously challenging the status quo and bringing forward innovative solutions
- Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.
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. Delivers solutions to abstract problems across functional areas of the business.
- Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.
- Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
- Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity
- Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy
- Resilient and comfortable working through large scale global change management
EDUCATION AND EXPERIENCE REQUIREMENTS
Required: M.D. or D.O. degree with active medical licensure in both the country of residence and the United States.
Minimum of three years of clinical medical practice experience.
Minimum of three years of industry experience in the plasma or whole blood sector.
At least two years of leadership or managerial experience within the industry.
Strong knowledge of U.S. FDA and European Union regulations pertaining to plasma donor eligibility, deferral criteria, and related compliance standards is highly desirable.
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