Senior HEOR Manager Patient-Reported Outcome m/f/d

Bayer Consumer Care AG; Basel; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Bayer Consumer Care AG is seeking a Senior HEOR Manager to drive patient-reported outcomes (COA/PRO) across therapeutic areas. You will lead COA strategy, select appropriate COAs for trials, and manage external vendors while ensuring regulatory compliance throughout product lifecycles.

The role emphasizes collaboration with internal teams and external partners, optimizing COA data analysis and contributing to regulatory and scientific submissions.

Qualifikationen

• Master's degree in Life Sciences or related field; PhD preferred.
• 5+ years of health outcomes research with COA/PRO methodology and regulatory experience.
• Ability to analyze COA data and derive regulatory-ready insights.
• Experience leading cross-functional teams and managing external vendors.
• Knowledge of eCOA migrations and latest implementation standards.

Aufgaben

• Lead the development and execution of strategic COA plans for products across therapeutic areas, owning the COA Strategy Document for each program.
• Guide internal teams in selecting appropriate COAs for clinical trials and provide input into clinical documents throughout the trial lifecycle.
• Lead the scientific execution of COA projects with external vendors and internal stakeholders.
• Provide guidance to project teams, ensuring adherence to COA regulatory requirements and best practices.
• Oversee COA validation and interpretation, ensuring psychometric evidence meets regulatory and HTA criteria.
• Collaborate on COA data analysis and reporting, preparing regulatory or scientific documents as needed.
• Prepare COA-related regulatory and scientific submissions, leading relevant sections for regulatory agencies.
• Stay current with COA-related scientific organizations and methodologies, incorporating advances into programs.

Kenntnisse

COA strategy

PRO methodology

Regulatory knowledge

Cross-functional leadership

Vendor management

Data analysis

Project leadership

Ausbildung

Master's degree in Life Sciences

PhD preferred

Jobbeschreibung

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is nolonger a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives ofthose around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you'rehungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Senior HEOR Manager Patient-Reported Outcome (12 months contract) m/f/d

As a Senior HEOR Manager COAs/PROs, you are at the forefront of clinical outcome assessment (COA) activities and projects across various therapeutic areas within our organization, always prioritizing a 'patient-first' mindset. Your role is pivotal in COA strategic planning and execution, ensuring high impact and scientific integrity. You will collaborate and lead internal cross-functional teams and external vendors to successfully implement COA initiatives, including patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), and other COA assessments for clinical programs. Your mission is to enhance the patient experience from trial design to final reporting, ensuring commercial and regulatory success of products that include COAs in their endpoint measurement strategy across clinical lifecycles.

YOUR TASKS AND RESPONSIBILITIES:

• Lead the development and execution of strategic COA plans for products across therapeutic areas, owning the COA Strategy Document for each program;
• Guide internal teams in selecting appropriate COAs for clinical trials and provide input into clinical documents throughout the trial lifecycle;
• Lead the scientific execution of COA projects with external vendors and internal stakeholders;
• Provide guidance to project teams, ensuring adherence to COA regulatory requirements and best practices;
• Oversee COA validation and interpretation, ensuring psychometric evidence meets regulatory and HTA criteria;
• Collaborate on COA data analysis and reporting, preparing regulatory or scientific documents as needed;
• Prepare COA-related regulatory and scientific submissions, leading relevant sections for regulatory agencies;
• Stay current with COA-related scientific organizations and methodologies, incorporating advances into programs.

WHO YOU ARE:

• At least a master's degree in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics, or a related field. A Ph.D. is preferred;
• 5+ years of applied experience in health outcomes research, with demonstrated leadership and expertise in COA/PRO methodology and regulatory requirements;
• Strong ability to analyze and validate COA data, apply COA validation methodologies, and derive regulatory-ready insights;
• Ability to develop strategies and implement tactics for optimal clinical outcome strategy addressing market access or regulatory needs globally;
• Excellent leadership skills with experience leading cross-functional teams and managing external vendors;
• Understanding of electronic COA migrations and latest eCOA implementation standards;
• Proven ability to interact effectively with internal and external stakeholders, navigating competing priorities;
• High degree of empathy and inclusive mindset to work with diverse external stakeholder groups.