Executive Director, Regulatory Affairs, Precision Medicine & Digital Health
Working with UsChallenging.
Meaningful.
Life-changing.
Those aren t words that are usually associated with a job.
But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
careers.
bms.
com/working-with-us.
Executive Director, Regulatory Affairs, Precision Medicine & Digital HealthThe Head, Precision Medicine & Digital Health, reports directly to the Vice President of Regulatory Innovation & Enterprise Delivery and has leadership responsibility for global regulatory strategy and execution for Precision Medicine and Digital Health products across the BMS portfolio.
Position ResponsibilitiesOversees a team of regulatory professionals to deliver compliant global regulatory strategies to support development of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our pharmaceutical products across therapeutic areasProvide innovative approaches to resolve complex regulatory issues and increase speed to patientsEnsure global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategiesEnsure high quality collaboration with Global Regulatory Leads and Regional Regulatory Leads by providing timely guidance and strategic partnership in health authority meetings and regulatory documentation spanning the drugs life-cycleProvides guidance on planning, writing and review of key dossier documents for submissions globallyRepresent BMS in key interactions with health authorities for precision medicine- and digital health-related topicsRepresent BMS on product partnership, vendor management and business development opportunitiesManage complex cross-functional stakeholder alignment to ensure high quality collaboration with stakeholders including Translational Medicine to drive robust development of biomarker, companion diagnostic, devices and digital health toolsRemains on the forefront of the relevant science and competitive landscape via actively contribution to policy shaping efforts including partnering with trade associations; viewed as an expert in its application to the regulatory processEnsures Global Regulatory Science representation as needed on internal governance committeesEngages with customers on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutionsAccountable for coaching and career development to staff to maximize their potentialDegree RequirementsSolid scientific background, PhD.
, M.
D.
, PharmD, MSExperience RequirementsSignificant experience in regulatory affairs and diagnostic-related development e.
g.
, >8-10 years.
Key Competency RequirementsDeep understanding of scientific content, complexities and diagnostic development including extensive experience of IDE submissions and approvalsExtensive experience of companion diagnostic and device development including developing and documenting the regulatory strategy in co-ordination with clinical plans and marketing objectivesProven track record of leading teams through interactions with health authorities and issue resolutionDeep understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization processesEffectively communicates complex, scientific content into logical components appropriate for the audience including regulatory strategy, issues and risks to senior leaders in GRS and the wider organizationRobust experience of working within a matrix organization with internal and external stakeholders; develops effective partnerships and relationships at all levelsStrong personal accountability for delivery; able to lead through strong facilitation, negotiation, influencing and networking skills to build alignment with internal and external stakeholders and lead the PM&DH teamDemonstrated ability to drive quality decision makingRobust understanding of global policy, laws, regulations and guidelines relating to precision medicine, devices and digital health productsSeeks multiple perspectives and listens openly to other view points; takes an enterprise view when making recommendationsSets clear and high expectations and holds self and others accountable for decisions and results achieved; demonstrates ownership of results within (and beyond) area of responsibilityFosters a continuous improvement mindset with a focus on integrating quality principles throughoutEnable and demonstrate the courage to speak up on issues and risks as well as on successes and recognitionsTravel:
Up to 20%If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.
com.
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Meaningful.
Life-changing.
Those aren t words that are usually associated with a job.
But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
careers.
bms.
com/working-with-us.
Executive Director, Regulatory Affairs, Precision Medicine & Digital HealthThe Head, Precision Medicine & Digital Health, reports directly to the Vice President of Regulatory Innovation & Enterprise Delivery and has leadership responsibility for global regulatory strategy and execution for Precision Medicine and Digital Health products across the BMS portfolio.
Position ResponsibilitiesOversees a team of regulatory professionals to deliver compliant global regulatory strategies to support development of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our pharmaceutical products across therapeutic areasProvide innovative approaches to resolve complex regulatory issues and increase speed to patientsEnsure global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategiesEnsure high quality collaboration with Global Regulatory Leads and Regional Regulatory Leads by providing timely guidance and strategic partnership in health authority meetings and regulatory documentation spanning the drugs life-cycleProvides guidance on planning, writing and review of key dossier documents for submissions globallyRepresent BMS in key interactions with health authorities for precision medicine- and digital health-related topicsRepresent BMS on product partnership, vendor management and business development opportunitiesManage complex cross-functional stakeholder alignment to ensure high quality collaboration with stakeholders including Translational Medicine to drive robust development of biomarker, companion diagnostic, devices and digital health toolsRemains on the forefront of the relevant science and competitive landscape via actively contribution to policy shaping efforts including partnering with trade associations; viewed as an expert in its application to the regulatory processEnsures Global Regulatory Science representation as needed on internal governance committeesEngages with customers on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutionsAccountable for coaching and career development to staff to maximize their potentialDegree RequirementsSolid scientific background, PhD.
, M.
D.
, PharmD, MSExperience RequirementsSignificant experience in regulatory affairs and diagnostic-related development e.
g.
, >8-10 years.
Key Competency RequirementsDeep understanding of scientific content, complexities and diagnostic development including extensive experience of IDE submissions and approvalsExtensive experience of companion diagnostic and device development including developing and documenting the regulatory strategy in co-ordination with clinical plans and marketing objectivesProven track record of leading teams through interactions with health authorities and issue resolutionDeep understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization processesEffectively communicates complex, scientific content into logical components appropriate for the audience including regulatory strategy, issues and risks to senior leaders in GRS and the wider organizationRobust experience of working within a matrix organization with internal and external stakeholders; develops effective partnerships and relationships at all levelsStrong personal accountability for delivery; able to lead through strong facilitation, negotiation, influencing and networking skills to build alignment with internal and external stakeholders and lead the PM&DH teamDemonstrated ability to drive quality decision makingRobust understanding of global policy, laws, regulations and guidelines relating to precision medicine, devices and digital health productsSeeks multiple perspectives and listens openly to other view points; takes an enterprise view when making recommendationsSets clear and high expectations and holds self and others accountable for decisions and results achieved; demonstrates ownership of results within (and beyond) area of responsibilityFosters a continuous improvement mindset with a focus on integrating quality principles throughoutEnable and demonstrate the courage to speak up on issues and risks as well as on successes and recognitionsTravel:
Up to 20%If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.
com.
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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