Director of Epidemiology & Real-World Evidence

Alkermes; Boston (MA); Hybrid; USD 210,000 - 245,000; Full time

Job summary

Alkermes is seeking a Director, Head of Epidemiology to guide epidemiologic research across discovery and clinical development within our R&D organization. The role collaborates with program leaders for investigational and marketed products, designs research plans, and oversees direct reports and vendors.

This hybrid position requires 60% office time in Waltham, MA and 40% remote, with base salary between $210,000 and $245,000 plus a performance bonus.

Qualifications

• Accountability and a sense of urgency in leading critical projects.
• Can work both independently and collaboratively and to be able to effectively communicate with varied stakeholders, including senior management at Alkermes and external stakeholders, both verbally and in writing.
• Strategic and critical thinking skills.
• Ability to effectively operate and lead in a highly matrixed and dynamic environment.
• Excellent organizational skills, including budgeting and tracking.
• Understand the strengths and weaknesses of real-world data sources and can perform or direct queries and analyses from appropriate data sources to address strategic needs.

Responsibilities

• Coordinate cross-functional teams to define program strategies and identify epidemiologic research needs.
• Develop and maintain disease area reports describing demographics and comorbidities of focus diseases.
• Provide literature searches and support analyses of epidemiologic data for safety signals and regulatory queries.
• Provide epidemiologic reports to support regulatory filings (e.g., orphan designation).
• Lead pharmacoepidemiologic study design and execution with Safety, Clinical Development, Medical Affairs, and external vendors.
• Collaborate with HEOR on real-world data sources and pharmacoeconomic methods.
• Review observational study protocols, analysis plans, reports, and publications.
• Represent Alkermes at scientific forums.
• Educate stakeholders on pharmacoepidemiology resources; track deliverables; manage vendors; ensure SOP/regulatory compliance; budget activities.
• Establish scalable pharmacoepidemiology plans; track key deliverables and queries; establish and manage key vendors; ensure regulatory-compliant SOPs; budget and prioritize epidemiology needs.

Skills

Accountability

Urgency

Independent work

Stakeholder communication

Strategic thinking

Budgeting

Data queries

Education

PhD or ScD in Epidemiology

Job description

Alkermes is seeking a Director, Head of Epidemiology to guide epidemiologic research across discovery and clinical development within our R&D organization. The role collaborates with program leaders for investigational and marketed products, designs research plans, and oversees direct reports and vendors.

This hybrid position requires 60% office time in Waltham, MA and 40% remote, with base salary between $210,000 and $245,000 plus a performance bonus.