Reporting to the Chief Executive Officer, the Chief Medical Officer (CMO) will have accountability for all medical aspects of BD’s initiatives including the Medical and Clinical Affairs strategy and the implementation of the clinical development and operations plan. This role will provide strategic consultation and guidance on all decisions that have significant medical components and implications.
The CMO will collaborate with key internal and external stakeholders including CROs, key opinion leaders and investors and will serve as an ambassador for BD at external events and conferences. S/he will be responsible for developing and deepening relationships with BD’s customers.
S/he will work closely with business development, product development and medical staff on clinical aspects of statistical analysis, product creation methodology and product quality measurement as well as product improvement.
This role will provide medical leadership in product presentations to clients and other stakeholders (including BD’s Board of Directors) and in the development of customer-facing materials.
Working with a multidisciplinary team s/he will also be accountable for helping to secure regulatory authority approval for new products and in-country registration of these products worldwide.
The CMO is a key member of BD’s Management Committee, engaged in defining the overall business strategy and direction of the Company.
- Work with the Business Unit Presidents, regional leaders and global platform teams (including operations and manufacturing) to meet worldwide business objectives by providing medical insights and recommendations that will lead to effective business decisions.
- Thoroughly understand the global operating results, annual budgets, quarterly projections and long-term financial plan and align medical strategy to support the Company’s fiscal objectives.
- Contribute to and support medical/clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional processes designed to effectively deliver BD’s R&D portfolio.
- Oversee the design of scientifically rigorous and maximally cost-effective Medical Affairs programs for BD.
- Ensure that the overall scientific and medical content of all clinical programs is sound.
- Ensure the integration of pre-clinical and early clinical findings with planned clinical programs; work to secure cross functional alignment and/or transparent discussion of risks associated with clear plans to further investigate and track through clinical development.
- Implement medical/clinical R&D policies, SOPs and related directives.
- Oversee study progress and analyses for progress reporting and presentations to senior management.
- Oversee or directly prepare various official and regulatory documents for regulatory bodies and other agencies, and handle responses to regulatory agencies regarding questions about complex safety or efficacy issues.
- Serve as or appoint a medical monitor, responsible for the safety monitoring of all clinical trials.
- Ensure that serious adverse events are properly reported on a global basis.
- Manage multidisciplinary professionals and clinical scientists to support career and project advancement.
- Support any needed due diligence and prepare/present medically sound strategy and plans associated with business development opportunities.
- Representation of BD at national, regional and international conferences and events.
- Approval of all medical/clinical content of BD’s internal and external promotional materials.
- Review and approval of product labeling.
- Technical evaluation of new products and technologies under consideration for addition to BD’s product portfolio.
- Development of BD’s network of key opinion leaders worldwide to advocate on behalf of BD’s products and initiatives.
- Participation in media interviews and assistance in developing responses to requests from the media.
- Keep abreast of emerging models in the industry; identify and define new and innovative strategies to achieve business goals and objectives.
- Oversight and direction of design and evaluation of new products from prototype design and laboratory testing through clinical trials.
- Create an environment that attracts, retains and motivates a diverse and highly talented workforce. Select, coach and develop individuals for high performance and ensure that the Medical and Clinical Affairs organization is adequately staffed with highly capable talent.
- Board-Certified Physician with outstanding vision and technical leadership.
- Experience with regulatory submissions for medical and/or devices pharmaceutical devices (specifically Class III) both within and outside of the United States.
- A current unrestricted license to practice medicine.
- A minimum of 10 years professional post-residency experience in direct patient care.
- Global experience working in both developed and emerging markets.
- Experience designing and overseeing a Medical and Clinical affairs organization in a large, matrixed organization with a diverse product portfolio.
- Superior strategic planning skills.
- Excellent, respectful and persuasive communication skills.
- Passionate, hard worker and well organized professional with demonstrated ability to prioritize and multitask.
- Exerts sound judgment and discretion; assures confidentiality.
- Superb ability to work on teams and to partner cross-functionally.
- Flexible to work non-business hours as needed and to travel domestically and internationally.
- Ability to make effective presentations on complex topics to both medical and non-medical colleagues.
- Skilled in interpreting and adapting scientific clinical information for practical training and field application.
- Prior publications demonstrating the ability to write clearly and accurately.
- Experience in the development, conduct, and analysis of clinical trials, both within and outside of the United States.
- Knowledge of managedhealthcare systems, medical quality assurance, quality improvement and risk management.
- Strategic and innovative thinker with proven ability to communicate a vision and drive
- Demonstrated management, organizational and interpersonal skills.
- Ability to solve problems and execute on initiatives.
- Self-assured and results oriented.
- Experience and demonstrated successful leadership of case management, disease management and/or population health programs.
- Demonstrated ability to assess business needs, design and implement programs and evaluate results.
Job ID R-24532