Chief Medical Officer
Position SummaryThe Cepheid Chief Medical Officer is a critical role reporting directly into the President.
This high visibility position is pivotal to our success as an organization, as this person will be a conduit of information between key Cepheid stakeholders, external government and regulatory agencies, the medical profession, other healthcare providers, and scientific communities.
This individual will be responsible for providing input into the medical need and justification for new products, their proper intended uses and their impact on patient care, assisting with appropriate clinical trial design, and the development and management of advisory panels, while simultaneously providing technical expertise for product prioritization and development.
As a strategic thought leader, this individual will have the transformative opportunity to shape strategy by understanding deeply the scientific basis for our technologies and how they should be designed for maximum impact.
This person will have will have deep insight into current and future medical trends, and the ability to translate these insights into business requirements globally as they relate to our worldwide installed base.
The successful incumbent will drive market introduction/penetration of the company s products by providing clinical information, regulatory input, projected impact, and other related information.
The incumbent will partner with external scientific/clinical organizations/individuals to further product application, industry positioning, and market awareness.
The incumbent will build and lead the Medical and Scientific Affairs organization, including the newly created Medical and Scientific Liaison team.
The incumbent is an internationally recognized expert in diagnostics and the impact of timely, accurate and medically actionable information on patient care.
Essential ResponsibilitiesScientific & Medical Affairs:
Works with R&D functions to identify and evaluate markets for new disease areas or product improvements; provides input on new technologies and intellectual property issues.
In partnership with L1 team members, designs and drives execution of medical affairs-related strategic goals and objectives, in keeping with overall company strategyFacilitates adherence to US regulatory requirements and International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH), pharmacovigilance and Good Clinical Practice (GCP) guidelines through the development and maintenance of applicable Company Standard Operating Procedures.
Maintains effective ongoing relationships with external experts/consultants to provide medical and scientific support to the Company s prioritized business initiativesReviews and approves medical and scientific input for promotional and commercial activities as requested.
Organizes and builds the Medical and Scientific Liaison team at Cepheid to actively engage with clinicians and other providers for conveying medical and scientific information in an unbiased and highly credible mannerWorks closely with R&D counterparts to identify and evaluate new biomarkers for infectious diseases, opportunities for product improvements and disruptive new product concepts.
Actively engages with outside collaborators to explore new clinical applications and intended uses for existing productsProvides strategic direction, review, and direct approval of clinical studies related to product development and commercial/ marketing activities.
Attends and participates in research, standards, and clinical societies and conferences, and provides Cepheid with relevant intelligence updatesCommunicates research, development and strategically important market information to executive managementCreates/facilitates company medical and scientific advisory boards and reports back to senior managementChairs company workshops and participates as an invited speaker at National and International MeetingsSafety:
Patient safety is a top priority at CepheidProvides medical support for patient safety board and direct customer interactions as neededProvides clinical input to Risk Assessments, Failure Mode Effect Analysis (FMEA), and Health Severity assessments within the risk management processLeads medical risk assessments with Senior Management.
Review and comment on medical risk assessments for complaints; sign-off on reportability of Medical Device Reports (MDR)Reviews, updates and creates risk assessment documents related to potential product-specific malfunctionsIdentifies and reports any quality or compliance concerns and take immediate corrective actionComplies with and contribute to the Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulationsMay be required to interface with regulatory bodies (in collaboration with Clinical Affairs) regarding product discussions and questionsEducation or ExperienceCombined MD/PhD degrees with 15
years of clinical and translational research experience, ideally in Laboratory Medicine with Clinical Microbiology experience or Internal Medicine with Infectious Disease experiencePublished track record of research in Molecular DiagnosticsInternational recognition as an expert in Molecular Diagnostics 6
years managing peopleKnowledge and SkillsMedical Doctor with PhD in Genetics, Biochemistry, or Molecular BiologyConcentration in Laboratory Medicine, Internal Medicine or Pediatrics with strong focus on Infectious Disease/Virology.
Experience/prior oversight for risk assessment, patient safety & quality assurance processesStrong ability to make balanced business decisions; strong communication skills to effectively connect with the scientific audience as well as the ability to explain complex medical issues simply to a lay person; excellent interpersonal, organizational, and influencing skills; ability to work in a matrix environment and a motivational approach to managing othersAs the face of Cepheid to the external Medical and Scientific communities, this position requires exceptional written and oral communication skillsExcellent interpersonal skills and the ability work with a wide variety of people (physicians, laboratory staff, marketing representatives, etc.
) that will enable and maintain effective relationships with key externa opinion leaders/consultants to provide scientific support to the company s business initiativesDomestic and international travel required - up to 40%Knowledge of regulations and standards affecting IVDs and BiologicsIndustry, product and customer knowledge required.
Demonstrated leadership capabilities to direct a Medical and Scientific Affairs team.
Demonstrated expertise in interpretation, summarization and presentation of scientific data requiredDemonstrated expertise in scientific writing (e.
g.
published manuscripts in peer reviewed journals, investigator brochures, or clinical sections of PMA and 510K submissions) requiredPreferred QualificationsGlobal diagnostics market experience, including in developed and underdeveloped regionsStrong Infectious Disease backgroundAt Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow s science and technology.
We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Our global teams are pioneering what s next across Life Sciences, Diagnostics, Biotechnology and beyond.
For more information, visit.
Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Please contact us at applyassistance@danaher.
com to request accommodation.
Job SummaryJob number:
R1260755Date posted :
2024-02-28Profession:
ScienceEmployment type:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
This high visibility position is pivotal to our success as an organization, as this person will be a conduit of information between key Cepheid stakeholders, external government and regulatory agencies, the medical profession, other healthcare providers, and scientific communities.
This individual will be responsible for providing input into the medical need and justification for new products, their proper intended uses and their impact on patient care, assisting with appropriate clinical trial design, and the development and management of advisory panels, while simultaneously providing technical expertise for product prioritization and development.
As a strategic thought leader, this individual will have the transformative opportunity to shape strategy by understanding deeply the scientific basis for our technologies and how they should be designed for maximum impact.
This person will have will have deep insight into current and future medical trends, and the ability to translate these insights into business requirements globally as they relate to our worldwide installed base.
The successful incumbent will drive market introduction/penetration of the company s products by providing clinical information, regulatory input, projected impact, and other related information.
The incumbent will partner with external scientific/clinical organizations/individuals to further product application, industry positioning, and market awareness.
The incumbent will build and lead the Medical and Scientific Affairs organization, including the newly created Medical and Scientific Liaison team.
The incumbent is an internationally recognized expert in diagnostics and the impact of timely, accurate and medically actionable information on patient care.
Essential ResponsibilitiesScientific & Medical Affairs:
Works with R&D functions to identify and evaluate markets for new disease areas or product improvements; provides input on new technologies and intellectual property issues.
In partnership with L1 team members, designs and drives execution of medical affairs-related strategic goals and objectives, in keeping with overall company strategyFacilitates adherence to US regulatory requirements and International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH), pharmacovigilance and Good Clinical Practice (GCP) guidelines through the development and maintenance of applicable Company Standard Operating Procedures.
Maintains effective ongoing relationships with external experts/consultants to provide medical and scientific support to the Company s prioritized business initiativesReviews and approves medical and scientific input for promotional and commercial activities as requested.
Organizes and builds the Medical and Scientific Liaison team at Cepheid to actively engage with clinicians and other providers for conveying medical and scientific information in an unbiased and highly credible mannerWorks closely with R&D counterparts to identify and evaluate new biomarkers for infectious diseases, opportunities for product improvements and disruptive new product concepts.
Actively engages with outside collaborators to explore new clinical applications and intended uses for existing productsProvides strategic direction, review, and direct approval of clinical studies related to product development and commercial/ marketing activities.
Attends and participates in research, standards, and clinical societies and conferences, and provides Cepheid with relevant intelligence updatesCommunicates research, development and strategically important market information to executive managementCreates/facilitates company medical and scientific advisory boards and reports back to senior managementChairs company workshops and participates as an invited speaker at National and International MeetingsSafety:
Patient safety is a top priority at CepheidProvides medical support for patient safety board and direct customer interactions as neededProvides clinical input to Risk Assessments, Failure Mode Effect Analysis (FMEA), and Health Severity assessments within the risk management processLeads medical risk assessments with Senior Management.
Review and comment on medical risk assessments for complaints; sign-off on reportability of Medical Device Reports (MDR)Reviews, updates and creates risk assessment documents related to potential product-specific malfunctionsIdentifies and reports any quality or compliance concerns and take immediate corrective actionComplies with and contribute to the Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulationsMay be required to interface with regulatory bodies (in collaboration with Clinical Affairs) regarding product discussions and questionsEducation or ExperienceCombined MD/PhD degrees with 15
years of clinical and translational research experience, ideally in Laboratory Medicine with Clinical Microbiology experience or Internal Medicine with Infectious Disease experiencePublished track record of research in Molecular DiagnosticsInternational recognition as an expert in Molecular Diagnostics 6
years managing peopleKnowledge and SkillsMedical Doctor with PhD in Genetics, Biochemistry, or Molecular BiologyConcentration in Laboratory Medicine, Internal Medicine or Pediatrics with strong focus on Infectious Disease/Virology.
Experience/prior oversight for risk assessment, patient safety & quality assurance processesStrong ability to make balanced business decisions; strong communication skills to effectively connect with the scientific audience as well as the ability to explain complex medical issues simply to a lay person; excellent interpersonal, organizational, and influencing skills; ability to work in a matrix environment and a motivational approach to managing othersAs the face of Cepheid to the external Medical and Scientific communities, this position requires exceptional written and oral communication skillsExcellent interpersonal skills and the ability work with a wide variety of people (physicians, laboratory staff, marketing representatives, etc.
) that will enable and maintain effective relationships with key externa opinion leaders/consultants to provide scientific support to the company s business initiativesDomestic and international travel required - up to 40%Knowledge of regulations and standards affecting IVDs and BiologicsIndustry, product and customer knowledge required.
Demonstrated leadership capabilities to direct a Medical and Scientific Affairs team.
Demonstrated expertise in interpretation, summarization and presentation of scientific data requiredDemonstrated expertise in scientific writing (e.
g.
published manuscripts in peer reviewed journals, investigator brochures, or clinical sections of PMA and 510K submissions) requiredPreferred QualificationsGlobal diagnostics market experience, including in developed and underdeveloped regionsStrong Infectious Disease backgroundAt Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow s science and technology.
We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Our global teams are pioneering what s next across Life Sciences, Diagnostics, Biotechnology and beyond.
For more information, visit.
Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Please contact us at applyassistance@danaher.
com to request accommodation.
Job SummaryJob number:
R1260755Date posted :
2024-02-28Profession:
ScienceEmployment type:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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