Principal Epidemiologist - Pharmaceutical & Regulatory Expertise
Summary
J.S. Held is seeking a Principal Epidemiologist with extensive expertise in pharmaceutical epidemiology and regulatory affairs to join their Health Sciences team. This senior leadership role involves driving strategic growth, expanding client relationships, and leading complex pharmacoepidemiology engagements. The ideal candidate will lead studies, provide regulatory guidance, deliver scientific reports, and contribute significantly to business development while mentoring junior staff. The position requires a strong industry reputation and a proven ability to generate business.
Must Have
• Lead design and execution of pharmacoepidemiology studies, including post-market surveillance, risk-benefit analyses, and drug safety evaluations.
• Provide strategic guidance on regulatory submissions and compliance with FDA, EMA, and other global standards.
• Advise clients on pharmacovigilance systems and risk management plans.
• Deliver high-quality, defensible reports and presentations for regulatory, scientific, and client audiences.
• Build and maintain strong relationships with pharmaceutical companies, regulatory agencies, and industry stakeholders.
• Significantly contribute to business growth by bringing a book of business, established client relationships, and ideally a team of professionals.
• Shape the direction of the Health Sciences practice, identify new market opportunities, and drive revenue growth.
• Mentor and develop junior staff, fostering technical excellence, client service, and a collaborative culture.
• PhD in Epidemiology, Pharmacoepidemiology, or a closely related discipline.
• Minimum 20 years of experience in pharmaceutical epidemiology and regulatory affairs, with a proven track record of leadership and impact.
• Demonstrated ability to generate revenue, expand client portfolios, and contribute to organisational growth.
• Strong understanding of FDA, EMA, and global pharmacovigilance frameworks.
• Ability to lead and inspire teams in a fast-paced consulting environment.
• Exceptional written and verbal skills for both technical and non-technical audiences.
Perks
• Flexible work environment allows employees to work remotely, when needed
• Flexible Time Off Policy
• Medical, Dental, and Vision Insurance
• 401k Match
• Commuter Benefits
Company Description
Are you looking to join an organization that is growing and dynamic? What about a high-energy, collaborative environment that rewards hard work?
J.S. Held is a global consulting firm that combines technical, scientific, financial, and strategic expertise to advise clients seeking to realize value and mitigate risk. Our professionals serve as trusted advisors to organizations facing high stakes matters demanding urgent attention, staunch integrity, proven experience, clear-cut analysis, and an understanding of both tangible and intangible assets.
The firm provides a comprehensive suite of services, products, and data that enable clients to navigate complex, contentious, and often catastrophic situations.
Job Description
We are seeking a Senior Epidemiologist with deep expertise in pharmaceutical epidemiology and regulatory affairs to join our Health Sciences team. This senior leadership role is designed for a highly accomplished professional who will drive strategic growth, expand client relationships, and lead complex pharmacoepidemiology engagements. The ideal candidate will bring a strong industry reputation, a proven ability to generate business, and the capability to mentor and inspire teams.
Key Responsibilities
• Pharmacoepidemiology Leadership
Lead the design and execution of pharmacoepidemiology studies, including post-market surveillance, risk-benefit analyses, and drug safety evaluations.
• Regulatory Strategy & Compliance
Provide strategic guidance on regulatory submissions and compliance with FDA, EMA, and other global standards. Advise clients on pharmacovigilance systems and risk management plans.
• Scientific Analysis & Reporting
Deliver high-quality, defensible reports and presentations for regulatory, scientific, and client audiences. Translate complex data into actionable insights.
• Client Development & Relationship Management
Build and maintain strong relationships with pharmaceutical companies, regulatory agencies, and industry stakeholders. Significantly contribute to business growth by bringing a book of business, established client relationships, and ideally a team of professionals.
• Strategic Leadership & Growth
Shape the direction of the Health Sciences practice, identify new market opportunities, and drive revenue growth through innovative solutions.
• Team Development & Mentorship
Mentor and develop junior staff, fostering technical excellence, client service, and a collaborative culture.
• Cross-Functional Collaboration
Work closely with multidisciplinary teams (biostatistics, toxicology, risk assessment) to deliver integrated, high-impact solutions.
Qualifications
• PhD in Epidemiology, Pharmacoepidemiology, or a closely related discipline.
• Minimum 20 years of experience in pharmaceutical epidemiology and regulatory affairs, with a proven track record of leadership and impact.
• Demonstrated ability to generate revenue, expand client portfolios, and contribute to organisational growth.
• Strong understanding of FDA, EMA, and global pharmacovigilance frameworks.
• Ability to lead and inspire teams in a fast-paced consulting environment.
• Exceptional written and verbal skills for both technical and non-technical audiences.
Additional Information
Some of the Benefits We Have Include
J.S. Held understands all our employees are people and sometimes life needs flexibility. We work to always provide an environment that best supports and suits our team’s needs.
• Our flexible work environment allows employees to work remotely, when needed
• Flexible Time Off Policy
• Medical, Dental, and Vision Insurance
• 401k Match
• Commuter Benefits
A reasonable estimate of the salary range for this role is $200,000 - $300,000. Any offered salary range is based on a wide array of factors including but not limited to skillset, experience, training, location, scope of role, management responsibility, etc.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
By submitting your application, you acknowledge that you have read the J.S. Held Online Privacy Notice and hereby freely and unambiguously give informed consent to the collection, processing, use, and storage of your personal information as required and described therein. California residents can click here to learn more about the personal information we collect and here to learn about additional privacy rights that may be available.
Please explore what we’re all about at www.jsheld.com.
EEO and Job Accommodations
_We embrace diversity and our commitment to building a team and environment that fosters professional and personal enrichment is unwavering. We are greater when we are equal! J.S. Held is an equal opportunity employer that is committed to hiring a diverse workforce. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin,
disability, protected Veteran status, age, or any other characteristic protected by law. If you are an individual with a disability and would like to request for a reasonable accommodation, please email [email protected] and include “Applicant Accommodation” within the subject line with your request and contact information._
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J.S. Held is seeking a Principal Epidemiologist with extensive expertise in pharmaceutical epidemiology and regulatory affairs to join their Health Sciences team. This senior leadership role involves driving strategic growth, expanding client relationships, and leading complex pharmacoepidemiology engagements. The ideal candidate will lead studies, provide regulatory guidance, deliver scientific reports, and contribute significantly to business development while mentoring junior staff. The position requires a strong industry reputation and a proven ability to generate business.
Must Have
• Lead design and execution of pharmacoepidemiology studies, including post-market surveillance, risk-benefit analyses, and drug safety evaluations.
• Provide strategic guidance on regulatory submissions and compliance with FDA, EMA, and other global standards.
• Advise clients on pharmacovigilance systems and risk management plans.
• Deliver high-quality, defensible reports and presentations for regulatory, scientific, and client audiences.
• Build and maintain strong relationships with pharmaceutical companies, regulatory agencies, and industry stakeholders.
• Significantly contribute to business growth by bringing a book of business, established client relationships, and ideally a team of professionals.
• Shape the direction of the Health Sciences practice, identify new market opportunities, and drive revenue growth.
• Mentor and develop junior staff, fostering technical excellence, client service, and a collaborative culture.
• PhD in Epidemiology, Pharmacoepidemiology, or a closely related discipline.
• Minimum 20 years of experience in pharmaceutical epidemiology and regulatory affairs, with a proven track record of leadership and impact.
• Demonstrated ability to generate revenue, expand client portfolios, and contribute to organisational growth.
• Strong understanding of FDA, EMA, and global pharmacovigilance frameworks.
• Ability to lead and inspire teams in a fast-paced consulting environment.
• Exceptional written and verbal skills for both technical and non-technical audiences.
Perks
• Flexible work environment allows employees to work remotely, when needed
• Flexible Time Off Policy
• Medical, Dental, and Vision Insurance
• 401k Match
• Commuter Benefits
Company Description
Are you looking to join an organization that is growing and dynamic? What about a high-energy, collaborative environment that rewards hard work?
J.S. Held is a global consulting firm that combines technical, scientific, financial, and strategic expertise to advise clients seeking to realize value and mitigate risk. Our professionals serve as trusted advisors to organizations facing high stakes matters demanding urgent attention, staunch integrity, proven experience, clear-cut analysis, and an understanding of both tangible and intangible assets.
The firm provides a comprehensive suite of services, products, and data that enable clients to navigate complex, contentious, and often catastrophic situations.
Job Description
We are seeking a Senior Epidemiologist with deep expertise in pharmaceutical epidemiology and regulatory affairs to join our Health Sciences team. This senior leadership role is designed for a highly accomplished professional who will drive strategic growth, expand client relationships, and lead complex pharmacoepidemiology engagements. The ideal candidate will bring a strong industry reputation, a proven ability to generate business, and the capability to mentor and inspire teams.
Key Responsibilities
• Pharmacoepidemiology Leadership
Lead the design and execution of pharmacoepidemiology studies, including post-market surveillance, risk-benefit analyses, and drug safety evaluations.
• Regulatory Strategy & Compliance
Provide strategic guidance on regulatory submissions and compliance with FDA, EMA, and other global standards. Advise clients on pharmacovigilance systems and risk management plans.
• Scientific Analysis & Reporting
Deliver high-quality, defensible reports and presentations for regulatory, scientific, and client audiences. Translate complex data into actionable insights.
• Client Development & Relationship Management
Build and maintain strong relationships with pharmaceutical companies, regulatory agencies, and industry stakeholders. Significantly contribute to business growth by bringing a book of business, established client relationships, and ideally a team of professionals.
• Strategic Leadership & Growth
Shape the direction of the Health Sciences practice, identify new market opportunities, and drive revenue growth through innovative solutions.
• Team Development & Mentorship
Mentor and develop junior staff, fostering technical excellence, client service, and a collaborative culture.
• Cross-Functional Collaboration
Work closely with multidisciplinary teams (biostatistics, toxicology, risk assessment) to deliver integrated, high-impact solutions.
Qualifications
• PhD in Epidemiology, Pharmacoepidemiology, or a closely related discipline.
• Minimum 20 years of experience in pharmaceutical epidemiology and regulatory affairs, with a proven track record of leadership and impact.
• Demonstrated ability to generate revenue, expand client portfolios, and contribute to organisational growth.
• Strong understanding of FDA, EMA, and global pharmacovigilance frameworks.
• Ability to lead and inspire teams in a fast-paced consulting environment.
• Exceptional written and verbal skills for both technical and non-technical audiences.
Additional Information
Some of the Benefits We Have Include
J.S. Held understands all our employees are people and sometimes life needs flexibility. We work to always provide an environment that best supports and suits our team’s needs.
• Our flexible work environment allows employees to work remotely, when needed
• Flexible Time Off Policy
• Medical, Dental, and Vision Insurance
• 401k Match
• Commuter Benefits
A reasonable estimate of the salary range for this role is $200,000 - $300,000. Any offered salary range is based on a wide array of factors including but not limited to skillset, experience, training, location, scope of role, management responsibility, etc.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
By submitting your application, you acknowledge that you have read the J.S. Held Online Privacy Notice and hereby freely and unambiguously give informed consent to the collection, processing, use, and storage of your personal information as required and described therein. California residents can click here to learn more about the personal information we collect and here to learn about additional privacy rights that may be available.
Please explore what we’re all about at www.jsheld.com.
EEO and Job Accommodations
_We embrace diversity and our commitment to building a team and environment that fosters professional and personal enrichment is unwavering. We are greater when we are equal! J.S. Held is an equal opportunity employer that is committed to hiring a diverse workforce. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin,
disability, protected Veteran status, age, or any other characteristic protected by law. If you are an individual with a disability and would like to request for a reasonable accommodation, please email [email protected] and include “Applicant Accommodation” within the subject line with your request and contact information._
#LI-IM1
Apply tot his job
Apply To this Job