Medical Affairs Manager (M / F / D)
Tasks
* Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives
* Contribute to Patient Experience Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development
* Work with PRO implementation Lead to ensure PRO strategy is conducive to ePRO implementation capabilities
* Review trial statistical analysis plans for PROs to ensure that proposed analyses match with PRO endpoints as per protocol
* Review PRO-related TFL shells and actual results once finalized (PRO Team Lead to provide Senior Review)
* Review PRO outcomes in clinical study reports (PRO Team Lead to provide Senior Review)
* Respond to study team queries related to PED
* Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions
* Contribute to regulatory briefing documents as needed
* Contribute to HTA interactions as needed
* Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial
* Review externally-sponsored and real-world study protocols when PED are included
* Perform the activities described above for ongoing studies and those starting until the end of the contract
* Coordinate the performed activities with a junior PRO Team Member
* Coordinate the performed activities with the HEOR Asset Lead or Delegate
Qualification
* Master’s or Bachelor’s degree in a relevant discipline (e.g., health economics, medicine, pharmacy, public health, epidemiology)
* Minimum 5 years’ experience in the healthcare or pharmaceutical industry or consulting, working in the PRO field
* Hands on experience with PRO methodologies and operations across all phases of the product life cycle is preferred
* Track record of successful application of PROs with key external stakeholders such as FDA, EMA and relevant HTAs
* Knowledge and experience of Oncology therapy areas is strongly preferred
* Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organization’s advantage; generates new ideas and enables the organization to improve business performance.
* Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies in drug development, and applies this knowledge to design PRO strategies
* Ability to influence and navigate in a matrix organization, with proven ability to work cross-functionally, build coalitions and develop strong partnerships across functions
* Demonstrates strategic thinking and ability to travel up to 20%
* Outstanding writing and presentation skills and ability to work under pressure, to take accountability for business challenges, think strategically and tackle complex problems
* Intellectual curiosity and ability to identify trends and emerging patterns in areas such as PROs, Patient Experience Data, HEOR
Requirements
Start : 15.01.2025
Duration : 9 months
Capacity : 5 days per week
Location : 100% remote
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