Associate Director – Epidemiology

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Provide strategic leadership in epidemiology and operational execution within Global Research & Development.

• Act as the epidemiology lead primarily for Oncology R&D programs, while also providing support for Neurology programs as portfolio priorities require.

• Lead multidisciplinary teams in non-interventional studies, delivering study concept sheets, protocols, statistical analysis plans, interim analyses, and final study reports.

• Design and implement Natural History of Disease studies and external control arms.

• Oversee non-interventional post-marketing studies and produce submission-ready study reports.

• Collaborate with Clinical Development, GVHEOR, Real-World Evidence, Biostatistics, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.

• Write epidemiology and pharmacoepidemiology sections for global regulatory documents.

• Convey epidemiological data, study progress, risks, and timelines to US and EU Regulatory Leads and governance committees.

• Provide estimates of incidence, prevalence, survival, and comorbidity for forecasting, commercial strategy, due diligence, and prioritization of the pipeline.

• Identify, assess, and access suitable global real-world data assets.

• Lead RFPs, vendor evaluations, and negotiations for SOWs.

• Manage external investigators, CROs, and scientific steering committees to ensure studies adhere to budget, timelines, data integrity, and compliance standards.

• Guide biostatisticians and statistical programmers on analytical specifications and advanced epidemiological methodologies.

• Present research findings at oncology and neurology congresses and author peer-reviewed publications.

⛳️ Requirements

• Advanced degree (PhD, ScD, DrPH, or MS/MPH) in Epidemiology, Pharmacoepidemiology, Health Services Research, or a related quantitative public health discipline.

• A minimum of 4+ years of relevant experience for PhD holders or 6+ years for those with a Master's degree.

• Relevant experience in the pharmaceutical/biotechnology sector, an academic research institution, or an epidemiology/RWE-focused CRO.

• Proven hands-on experience in designing and executing epidemiological studies in rare diseases.

• Established history of leading epidemiological research in oncology.

• Demonstrated expertise in non-interventional study designs, including retrospective/prospective cohorts, disease registries, and synthetic/external control arms utilizing real-world data.

• Direct experience with complex longitudinal healthcare databases.

• Proven capability to independently lead cross-functional study teams, manage external vendor performance and budgets, and juggle multiple priorities.

• Exceptional written and verbal communication skills in English.

• Ability to work efficiently in a hybrid/remote matrix environment, with a willingness to travel approximately 10% as necessary.

• Previous experience in supporting neurology, neuro-oncology, or rare neurological conditions.

• Direct experience in preparing and defending epidemiology-driven regulatory submissions before FDA, EMA, MHRA, or PMDA.

• Experience with site-based data collection methods.

• Proficiency in statistical programming using SAS, R, or Stata, or familiarity with RWE analytical platforms like Aetion or Panalgo.

• Knowledge of post-marketing safety commitments, PASS/PAES protocols, and global pharmacovigilance regulations.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.

• Remote work arrangement.

• Hybrid/remote matrix environment.

• Travel approximately 10% as needed.