Medical Evidence Generation Manager

Over 10 years of hands-on experience in global medical affairs roles, including Real-World Evidence (RWE), clinical trials, and medical strategy across multiple therapeutic areas (Oncology, IBD, Rheumatology, Neurology, Rare Diseases)

Proven track record in leading Real-World Evidence and Clinical Trial Programs

Familiar with digital tools in evidence generation and medical communications; able to manage and deliver complex global projects independently and effectively

Expert in developing and executing medical strategies, managing clinical studies, and generating impactful evidence to support product value and patient outcomes globally

Patient-Centered & Market-Oriented Approach: deep understanding of patient needs, payer requirements, and value communication; skilled in developing instruments and integrating patient voice into development plans

Provide real world evidence (RWE), outcomes research (OR) & epidemiology support (Epi) for products from development through launch and commercialization across the product lifecycle

Collaborate and align internally with other internal and external teams within a multi-disciplinary framework to meet product needs

Lead the development and execution of plans to elucidate unmet clinical, economic, and patient-centered needs and product value

Lead the periodic revision and updating of evidence-generation plans considering newly available knowledge

Communicate evidence-generation plans and resulting study findings to relevant internal and external audiences as effectively as possible

Work within a multidisciplinary, matrixed organization to lead development and creation of successful
evidence generation projects

Design, implement and communicate results of RWE, OR and Epi studies that help achieve product-
specific objectives

Participate in cross-functional teams related to product development and commercialization

Collaborate and partner with key internal / external stakeholder colleagues and external key opinion
leaders to ensure successful implementation of evidence generation plans

Focus on research activities such as prospective and retrospective observational studies, research on disease history, treatment, drug use and adherence as well as studies on product effectiveness and cross-sectional surveyes of key healthcare stakeholders

Cover systematic literature reviews, the development/validation of patient-reported outcome and PRO and HRQoL instruments, as well as the preparation and review of study protocols, statistical analysis plans, and reports

Focus on biologic therapy, oncology, rheumatology, biosimilars

Development and management of the global medical plan

Medical expertise and customer insights to the brand team

Contribution to local clinical operations activities

Oversee the phase III-B/IV trial program by holding an effective relationship with the Clinical Operations team

KOL engagement plan and execution

Provide medical/scientific support and training for internal staff or vendors

Oversight of the execution of clinical trials

Medical strategy and planning

Implementation of the field-based activities of the Global Medical Plan for the product and provides field insights

Staying abreast of internal and external developments, trends and other dynamics to maintain a fully current view and perspective of internal/external influencers and/or implications for the assigned product

Maintaining the highest standards and levels of scientific and clinical knowledge in therapeutic area (publications, interactions with TAEs, continuous communication and effective partnering with affiliates)

Evidence generation

Collecting insights from TAEs on scientific evidence gaps as part of medical strategy

Knowledge exchange

Providing education on therapeutic domain, clinical development program, MoA, MoD

Sharing information with TAEs and Global Clinical Operational Team

Recognition and support of the educational needs of KOLs

Continuous involvement of selected KOLs in company projects

Maintenance of high-level therapeutic areas and product knowledge, including continuous learning, participating in congresses, trainings, CME (continuous medical education) events

Organization of satellite symposia and workshops on national conferences

Support of market access, evaluation of HTA documentation, collaboration and advice for HTA experts

Selection of sites/ evaluation of sites proposed for clinical trials

Input into/ discussion of clinical trials projects

Monitoring progression of clinical projects on territory, reactive support for CRO

Special programs conducted after clinical trials

Work on medical information booth during international & local conferences

Medical budget planning

Primary contact with investigative sites during site start-up activities with responsibility for collecting the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations

Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations, and the Investigator Package Plan

Maintenance of allocated site information in the Trial Tracker TM Site Information Module study

Act as contact for the project team and study sites

Develop and/or maintain tracking systems for clinical projects (e.g. payments, drugs, study documents)

Support PMs in developing country-specific study documents

Support monitoring responsibilities as assigned by the supervisor