Director, Medical Outcomes Research
Viatris
10 days ago
Remote
United States
Medical Affairs
Director, Medical Outcomes Research
Key Responsibilities
- Lead and execute US and global cross-functional integrated evidence generation plans for medical affairs, clinical development, market access/HEOR, regulatory affairs, and commercial needs (including Women’s Health).
- Design and execute retrospective and prospective observational studies (burden-of-illness, natural history, incidence/prevalence) to assess disease impact, effectiveness, and safety.
- Lead comparative evidence generation: CER using real-world databases; ITC using clinical trial data; External Control Arms (ECA) using integrated real-world and clinical trial data.
- Lead systematic literature reviews and meta-analyses to support internal decisions, HTA dossier submissions, and regulatory requirements.
- Integrate patient-reported outcomes (quality-of-life instruments) into clinical trials; oversee patient surveys and validated instruments for regulatory/HTA.
- Develop Outcomes Research strategies across the innovation portfolio, ensuring clinical, humanistic, and economic endpoints are incorporated across development phases.
- Collaborate with cross-functional teams (clinical development, medical affairs, market access, regulatory, commercial) and build relationships with academic, healthcare, and payer stakeholders.
- Communicate findings/strategies to senior leadership and via peer-reviewed publications, congresses, and advisory meetings.
- Develop/review protocols, statistical analysis plans (SAPs), and reports; ensure regulatory/ethical compliance (privacy, patient consent).
- Manage real-world data sources and apply advanced statistical/epidemiology/health economics methods; ensure data quality and integrity.
Minimum Qualifications
- Master’s degree required; PhD/MD in epidemiology, public health, biostatistics, or related field strongly preferred.
- Required: depth/breadth in Outcomes Research (observational studies, PROs/HRQoL, clinical-economic modeling, meta-analysis).
- 5 years biopharmaceutical industry experience in evidence generation/Outcomes Research with successful delivery.
Additional Requirements/Skills
- Strong collaboration across internal teams and with HCPs, policymakers, and payers.
- Knowledge of drug development, registration, commercialization, and market access.
- Excellent written/verbal communication; experience with large global datasets and complex analyses.
- Technical expertise: protocol development, methods/algorithms, statistical/data analysis plans, publication insights.
- Record of peer-reviewed real-world evidence/Outcomes Research/epidemiology publications.
- Remote role; travel up to 30%.
- English proficiency required.
Compensation
- Salary range: $112,000 - $236,000 (exact compensation varies by skills, experience, and location).
Key Responsibilities
- Lead and execute US and global cross-functional integrated evidence generation plans for medical affairs, clinical development, market access/HEOR, regulatory affairs, and commercial needs (including Women’s Health).
- Design and execute retrospective and prospective observational studies (burden-of-illness, natural history, incidence/prevalence) to assess disease impact, effectiveness, and safety.
- Lead comparative evidence generation: CER using real-world databases; ITC using clinical trial data; External Control Arms (ECA) using integrated real-world and clinical trial data.
- Lead systematic literature reviews and meta-analyses to support internal decisions, HTA dossier submissions, and regulatory requirements.
- Integrate patient-reported outcomes (quality-of-life instruments) into clinical trials; oversee patient surveys and validated instruments for regulatory/HTA.
- Develop Outcomes Research strategies across the innovation portfolio, ensuring clinical, humanistic, and economic endpoints are incorporated across development phases.
- Collaborate with cross-functional teams (clinical development, medical affairs, market access, regulatory, commercial) and build relationships with academic, healthcare, and payer stakeholders.
- Communicate findings/strategies to senior leadership and via peer-reviewed publications, congresses, and advisory meetings.
- Develop/review protocols, statistical analysis plans (SAPs), and reports; ensure regulatory/ethical compliance (privacy, patient consent).
- Manage real-world data sources and apply advanced statistical/epidemiology/health economics methods; ensure data quality and integrity.
Minimum Qualifications
- Master’s degree required; PhD/MD in epidemiology, public health, biostatistics, or related field strongly preferred.
- Required: depth/breadth in Outcomes Research (observational studies, PROs/HRQoL, clinical-economic modeling, meta-analysis).
- 5 years biopharmaceutical industry experience in evidence generation/Outcomes Research with successful delivery.
Additional Requirements/Skills
- Strong collaboration across internal teams and with HCPs, policymakers, and payers.
- Knowledge of drug development, registration, commercialization, and market access.
- Excellent written/verbal communication; experience with large global datasets and complex analyses.
- Technical expertise: protocol development, methods/algorithms, statistical/data analysis plans, publication insights.
- Record of peer-reviewed real-world evidence/Outcomes Research/epidemiology publications.
- Remote role; travel up to 30%.
- English proficiency required.
Compensation
- Salary range: $112,000 - $236,000 (exact compensation varies by skills, experience, and location).