Summary of Role:

The Senior Director, Epidemiology is a leader who shapes evidence generation strategy across therapeutic areas while driving technical excellence and cross-functional collaboration. This role combines deep epidemiologic expertise with executive presence, leading teams to deliver innovative real world evidence that advises critical business decisions throughout the product lifecycle, with an emphasis on applications in Clinical Development, Regulatory, and Safety.  As a key member of the Epidemiology and Real World Science Department leadership team, you will influence both internal strategy and external scientific discourse while building and developing high-performing teams. 

Accountabilities:

Strategic Leadership & Execution

• Develop and implement comprehensive epidemiology strategic plans aligned with corporate objectives across assigned therapeutic areas 

• Advise the planning, prioritization, and execution of epidemiology deliverables including systematic literature reviews, real world data analyses, and observational studies/disease registries 

• Optimize resource allocation and operational efficiency, ensuring deliverables meet quality, budget, and timeline requirements while incorporating innovative methodologies 

• Collaborate with the department head on department-level strategic planning, including workforce planning, external resource evaluation, and real world data source assessment 

• Navigate organizational ambiguities and policy complexities to ensure successful execution of critical initiatives 

• Identify process gaps and lead the development and maintenance of Standard Operating Procedures and Process Guides 

Cross-Functional Collaboration

• Serve as the epidemiology lead on cross-functional therapeutic area teams, partnering with Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Commercial/Marketing, and HEOR 

• Engage proactively with senior and executive leadership to integrate epidemiologic evidence into strategic decision-making throughout the product lifecycle 

• Break down functional silos through influence, conflict resolution, and negotiation to achieve shared objectives 

• Represent the department in high-level corporate meetings and critical initiatives 

• Lead or contribute to R&D and corporate process improvement initiatives, finding opportunities to enhance efficiency and impact 

• Assess and address diverse team member needs, translating sophisticated epidemiologic concepts for varied audiences 

• Provide executive-level presentations and recommendations that shape business strategy 

Technical Excellence & Innovation

• Serve as a recognized technical authority in epidemiologic methods, including observational study design, causal inference, safety signal quantification, and disease epidemiology 

• Apply sophisticated analytical approaches using SAS, R, Python, or other statistical software to extract meaningful insights from sophisticated real world data sources 

• Ensure all epidemiology deliverables reflect current standard processes and methodological advancements in pharmacoepidemiology 

• Provide experienced technical guidance and scientific rigor across systematic literature reviews, database studies, and registry analyses 

• Contribute epidemiologic expertise to study protocols, case report forms (CRFs), clinical conference materials, and regulatory documents 

• Author and review scientific manuscripts, abstracts, and presentations based on observational study data, maintaining high publication standards 

• Work with authors, referees, and in-house reviewers to ensure scientific quality and accuracy 

• Stay current with emerging methodologies and data sources, recommending innovations that advance departmental capabilities 

Leadership & People Development

• Provide direct line management and leadership for Epidemiologists within assigned therapeutic areas, fostering a culture of scientific excellence and collaboration 

• Mentor team members in epidemiologic methods, critical thinking, and professional development, supporting their growth as technical authorities and leaders 

• Actively teach and mentor colleagues both within and outside the department, contributing to organizational capability building 

• Lead vendor and contractor relationships, ensuring external partners deliver high-quality work aligned with strategic objectives 

• Champion professional development for self and direct reports, creating opportunities for skill enhancement and career advancement 

• Identify and develop future leaders within the department 

• Conduct performance evaluations, provide constructive feedback, and support career progression for team members 

• Build a diverse, inclusive, high performing team environment that values different perspectives and approaches 

External Influence & Thought Leadership

• Represent the company and Epidemiology Department in interactions with regulatory authorities, Scientific Advisory Boards, and other external partners 

• Influence industry standards and guidelines through active leadership in professional societies, industry associations, and regulatory working groups 

• Build the company's reputation as a leader in rare disease epidemiology through publications, presentations, and scientific discourse 

• Leverage deep expertise in rare disease epidemiology to advance understanding of disease burden, natural history, and treatment outcomes 

• Establish and maintain relationships with key opinion leaders and external research collaborators 

• Contribute to the broader scientific community through peer review, conference participation, and collaborative research initiatives 

• Serve as a spokesperson for the organization at scientific conferences and industry events 

• Travel may be required (up to 10%). 

Required Skills and Education:

• PhD / DSc / DrPH in Epidemiology with minimum 12 years post-graduation experience, or MPH/MSc in Epidemiology with minimum 15 years post-graduation experience 

• Minimum 6 years of direct line management experience of multiple reports  

• The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.  

• Demonstrated expertise in epidemiologic methods, observational study design, causal inference, and real world data analysis 

• Proficiency with SAS, R, Python, or other statistical software packages Thorough and current knowledge of pharmacoepidemiology methods and applications 

• Strong understanding of safety signal quantification and risk-benefit assessment  

• Consistent record of publications in peer-reviewed journals 

• Exceptional oral and written communication skills with ability to present sophisticated information to diverse audiences 

• Strong attention to detail, scientific rigor, and commitment to quality 

• Experience working optimally in cross-functional, matrixed environments 

• Demonstrated ability to influence senior partners and drive consensus 

• High degree of self-motivation, organization, and adaptability 

• Comfort working in a fast-moving environment with evolving priorities

Desired Skills:

• Deep expertise and demonstrated experience in rare disease epidemiology 

• Knowledge of drug development processes and regulatory requirements across the product lifecycle 

• Experience collaborating with regulatory authorities (FDA, EMA, etc.) 

• Active leadership roles in professional societies (ISPE, ISPOR, etc.) or industry associations 

• Track record of thought leadership through publications, presentations, and external engagement 

• Experience with multiple real world data sources including claims databases, electronic health records, and patient registries 

• Experience in registry development, implementation, and analysis 

The annual base pay for this position ranges from $229,047 to $343,571. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an 9at-will position9 and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted