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We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Platform & Innovation Lead for Medical Affairs is the voice of Medical Affairs within the Advanced Drug Delivery Systems platform and Innovation teams. Oversees Medical Affairs strategy from preclinical, toxicology to clinical, and human factors, as well as post marketing follow up. The Platform Lead develops a team of core team members for products under development & product life cycle as well as managers.
Responsibilities:
Sharing clinical expertise, providing input into medical strategy and tactical plans, as well as acting as a sounding board to the emerging questions and challenges from the team
Accountability of the Medical Affairs strategy for all products under their platform
Leads development and implementation of the Medical Affairs strategy. Ensure those are aligned with the needs of product development
Directs and is responsible for evidence generation plans for each respective platform / product and ensures these plans are aligned with the business and market access needs
Engages with Subject Matter Experts, new customers, and provides scientific support to the platform for managing new opportunities
Collaborates with Health Economics & Outcome Research, R&D and Marketing to ensure that all evidence generation plans are aligned to the broader evidence generation needs for each respective product and platform
Creates scientific publication strategy for the platform
Ensures resources are aligned for executing studies on budget and on time
Directs and oversees risk management activities for products across the product development workstreams, ensuring medical input is provided throughout each development phase
Reviews all claims & adProm material related to products within their platform
Participates in Advanced Drug Delivery Systems LT meetings and represent MA at the New Product Development council and in innovation discussions
Ensures a total alignment exists between the functional leads and what their team members are doing
Prioritizes activities within their platform to ensure the workload remains acceptable and negotiates resources with the Platform VP/GM
Serves as the senior medical leader to the R&D organization, providing medical direction, input and guidance in all platform related R&D and LT forums
Approves all MA change control responses for products within their platform
Approves Clinical Evaluation Report for products under their respective platforms and ensures MA aspects of Post Market Surveillance
Drives innovation under their respective platform
Provides medical support and input to new product development and R&D innovation workstreams, ensuring all plans and ideas have medical relevance
Evaluates new product or technology opportunities/concepts, and if supported, develops an evidence pathway, including budget projections, which would be required to ensure market success/product adoption
Management of safety/medical issues for their respective products
Qualifications:
Pharm.D is highly desired or MD is acceptible
Demonstrated Leadership skills
Knowledge of either Preclinicals, Toxicology, Clinicals or Human Factors
Understanding of Design Control and knowledge of combination product regulation
Customer focused, ability to interact with internal & external customers
Demonstrated capability for critical thinking, excellent analytical, and problem solving skills
Ability to integrate medical, scientific, and technical information and effectively communicate the data to customers, internal collaborators, and the Scientific community
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
