J.S. Held LLC
Principal Epidemiologist Pharmaceutical Regulatory Expertise
J.S. Held LLC, Redmond, Washington, United States, 98052
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.
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.
Benefits
Our flexible work environment allows employees to work remotely, when needed.
Flexible Time Off Policy.
Medical, Dental, and Vision Insurance.
401(k) Match.
Commuter Benefits.
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, responsibilities and activities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
EEO and Job Accommodations We embrace diversity and our commitment to building a team and environment that fosters professional and personal enrichment is unwavering. 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 jobs@jsheld.com and include “Applicant Accommodation” within the subject line with your request and contact information.
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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.
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.
Benefits
Our flexible work environment allows employees to work remotely, when needed.
Flexible Time Off Policy.
Medical, Dental, and Vision Insurance.
401(k) Match.
Commuter Benefits.
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, responsibilities and activities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
EEO and Job Accommodations We embrace diversity and our commitment to building a team and environment that fosters professional and personal enrichment is unwavering. 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 jobs@jsheld.com and include “Applicant Accommodation” within the subject line with your request and contact information.
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