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Patient Centered Outcomes Research Lead 

Purpose:
The P-COR Lead is responsible for clinical outcome assessment (COA) related activities and projects across any therapeutic area within the organization, with a strong ‘patient-first’ mindset. The role is reliant on a capability for COA strategic planning and thinking, high impact and impeccable scientific integrity. This position involves collaboration and leadership with internal cross-functional teams and external vendors to ensure the successful implementation and completion of COA initiatives, including patient- reported outcomes (PROs), clinician-reported outcomes (ClinROs), and other COA assessments for clinical programs.

The purpose of the position is to maximize opportunities to enhance the patient experience, from trial design to final reporting. While leading COA related project activities, the incumbent uses his/her expertise and insights to inform patient-centered clinical design and further leads the identification of concrete additional regulatory or market access requirements that might be needed within a clinical program (e.g., COA validation activities outside the trial, exit interviews).

The ultimate end goal is to result in commercial and regulatory success of products that include COAs in their endpoint measurement strategy across clinical lifecycles.

Scope:
Global role

Key Tasks:
• Lead the development, creation and execution of strategic clinical outcome assessment (COA) plans for products in all therapeutic area across the company.
• Guide internal teams for clinical programs in choosing the appropriate COAs for clinical trials and provide input into the majority of clinical documents as needed, throughout the clinical trial lifecycle (e.g., protocols, statistical or psychometric analysis plans, results, and/or clinical reports).
• Lead the scientific execution of COA projects from start to finish with outside vendors and internal stakeholders (i.e. P-COR Project Manager, clinical, medical affairs, market access, regulatory, and commercial teams or beyond).
• Provide guidance and direction to project teams, ensuring adherence to COA specific regulatory requirements, best practices and industry standards related to COAs, including advising the scientific rigor for translation, cultural adaptation and electronic COA implementation activities within trials.

•Oversee and own COA content validation and psychometric validation activities, analyses and outputs.
• Work with biostatisticians/psychometricians, clinical and data management teams to interpret and report COA data and prepare and submit regulatory or scientific documents as needed (e.g. FDA or EMA dossiers, briefing books, and manuscripts).
• Lead in preparing relevant sections of meetings, documentation and communication for regulatory agencies (Type C meetings, dossiers and briefing books) or manuscripts in support of communication and commercial product goals with other cross-functional teams (e.g., regulatory, clinical teams, and medical writing).
• Stay up to date with COA related leading scientific organizations and bodies (e.g. C-Path Institute, PCORI, ISPOR, ISOQOL etc.) and recent methodologies or latest hot topics.

Key Working Relation:

Internal:
o P-COR Project Manager, on a regular basis
o Clinical, Medical Affairs, Regulatory, Commercial, Digital Health and more closely, with Market Access Leads throughout COA project lifecycles
o Product Teams (PTs) during COA related touchpoints and needs for specific program
o The CD&PE and CCC team members and other project scientific related nuclei

External:
o Outsourcing partners/vendors
o Clinical experts
o Patient advocacy organizations or beyond

Skills & Qualifications:
• Education: At least a master’s degree in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics, or a related field. Ph.D. is preferred.
• Experience: Minimum of 5 years of applied experience and leadership in health outcomes research, ideally in the COA/PRO area. In-depth knowledge of COA methodologies and regulatory requirements.
• Analytics: Strong ability to understand and analyze COA data, apply COA validation methodologies (e.g., translation and linguistic validation) and output for qualitative and quantitative COA research methods to derive rigorous regulatory ready insights
• Strategy: Strong ability to develop strategies and implement tactics for optimal clinical outcome strategy, to address any market access or regulatory needs globally
• Leadership: Excellent leadership and communication skills, collaboration and communication skills to ensure implementation of COA strategies in for all nuclei
• Digital: Understanding of electronic COA migrations from paper, BYOD and/or latest eCOA implementation standards
• Interaction: Proven experience in successfully interacting with multiple stakeholders internally and externally, while leading COA activities within cross-functional teams with strong problem-solving.
• External collaboration: High degree of empathy and inclusive mindset to work with diverse external stakeholder groups
• Strong ability to self-organize: Collaborate effectively without hierarchical authority and with accountability, pro-active and inclusive mindset, strong display of DSO behaviors

Location:

Spain : Cataluña : Barcelona  

Division:

Pharmaceuticals 

Reference Code:

854833