Director, Epidemiology

The Director, Head of Epidemiology serves as an important resource to the Alkermes R&D organization. This critical leadership role is tasked to advise both discovery and clinical development programs through better understanding of target disease populations, timely epidemiologic support to safety queries, and contribute to regulatory filings as needed. The incumbent will collaborate closely with cross-functional program leaders for both investigational and marketed products to identify program needs that can be addressed through epidemiologic research and then design and deliver on those research plans.

The position includes management oversight of direct reports and vendors.

The Director, Head of Epidemiology serves as an important resource to the Alkermes R&D organization. This critical leadership role is tasked to advise both discovery and clinical development programs through better understanding of target disease populations, timely epidemiologic support to safety queries, and contribute to regulatory filings as needed. The incumbent will collaborate closely with cross-functional program leaders for both investigational and marketed products to identify program needs that can be addressed through epidemiologic research and then design and deliver on those research plans.

The position includes management oversight of direct reports and vendors.

• Coordinate with cross-functional discovery and product teams to understand program strategies and needs and identify potential epidemiologic research that supports program goals.
• Develop and maintain epidemiology disease area reports describing the demographics and comorbidities of diseases of focus associated with Alkermes discovery targets and investigational and marketed products.
• Provide epidemiologic literature search as well as support analyses of epidemiologic data sets to aid DSPV safety signal investigations, ad hoc queries, aggregate reports and epidemiologic studies as well as supporting Clinical Development queries regarding focus disease states.
• Provide epidemiologic reports to support regulatory filings as needed (e.g., orphan drug designation applications)
• Lead pharmacoepidemiologic study design and execution in close partnership with Drug Safety, Clinical Development and Medical Affairs stakeholders as well as with external vendors.
• Collaborate with Health Economics and Outcomes Research (HEOR) group on real-world data sources, strategic evidence generation, and pharmacoeconomic methodology.
• Participate in reviews of observational research study protocols, analysis plans, study reports, and associated scientific publications.
• Effectively represent Alkermes at scientific forums.
• Establish a vision and plan for scaling pharmacoepidemiology with future company growth. This will include:
  • Educating key stakeholders on pharmacoepidemiology resources and capabilities
  • Tracking of key deliverables and queries
  • Establishing and managing key vendors for needed contract services
  • Ensure that processes/SOPs relating to pharmacoepidemiology activities are compliant to regulatory requirements
  • Budgeting and prioritization of epidemiology activities and needs

• PhD or ScD in Epidemiology is preferred.
• Five or more years of experience in the health science-related field, and at least 3 years in the pharmaceutical industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including 2 years epidemiology/pharmacovigilance experience.
• Experience in managing direct reports strongly desired.
• Knowledge of pre- and post-marketing US and EU regulations desirable.

• 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.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the…