Nordic Evidence Generation and Early Pipeline Lead

Major Accountabilities:

The EG and Early Pipeline Lead is accountable for:

Early Pipeline (60%):

• Co-lead and drive the early portfolio work in tight collaboration with HEOR/V&A colleagues upon NxLT direction
• Prepare and give input to early pipeline assessment work focusing on medical, V&A, EG and commercial aspects to estimate gaps and opportunities with future launches
• Liaise with the relevant global functions to get deeper insights into the substances/indications in scope
• Proactively map out in tight collaboration with relevant country stakeholders (Medical Directors+) areas of opportunities for attracting GDD and BMR clinical trials
• Build strong relationships to key global stakeholders in GDD/BMR to strongly lift Nordic opportunities for clinical trials
• Connect with relevant external stakeholders to maximize impact of Nordic trial opportunities (Med. Agencies etc.)

Evidence generation (40%):

• Leading the work with the exploratory integrated evidence generation strategy and plans (Nordic IEP) in close collaboration with relevant medical affairs, market access and commercial roles, to meet increasing external EG demands from payers, HCPs, policymakers and patients to secure, maintain and grow access in addition to timely preparing prioritized pipeline assets at a Nordic level (from an EG perspective)
• Based on the IEP – lead and execute on the key projects/studies identified with an aim to maximize impact with a focus on reimbursement and clinical adoption
• Shaping the mindset and educate all relevant parties in analysis and planning for future launches
• Building networks and relationships with partners across the organization, including external partners, that may be able to contribute or provide knowledge and insights relevant to pipeline planning
• Timely delivery and study budget follow-up for IE priorities, in close collaboration with study lead, including development of concept sheets for global approvals, protocols, study report and scientific disclosure, including driving IS methodology when applicable.
• Shaping and building strategic partnerships with Health Care Organizations/Third Party Organization/PLS and academic institutions to access external data source/analysis, ensuring information governance and data protection both at country and at Nordic level. Including shaping external health data ecosystems and policies around these at country level in tight x-func collaboration and as part of extended local leadership structures Supporting all relevant working groups in developing approaches for obtaining all relevant internal and external insights for analysis work
• Contributing with technical expertise and research methodological understanding for observational/epidemiologic research, and health technology or other outcome assessment
• Ensuring quality and performance standards for IE projects are realistic and attained, and studies are conducted in line with compliance framework
• Contributing to early identification of the priorities in TAs and striving for earlier planning and budget for IE studies
• Anticipating and evaluating future market needs and trends for IE information within specified health care environments

Key Performance Indicators:

•             Achievement IEP (Integrated Evidence plans) for TAs

•             Timely planning and execution of IE study priorities driving positive reimbursement and clinical adoptions

•             Leverages health outcomes information in appropriate scientific venues and leverages local dissemination plans for IE results in collaboration with cross-functional team

•             Close collaboration with medical affairs, development, market access, commercial, Nordic trial manager and digital

•             Alignment with local/global and external experts to build best-practice and innovative IE projects

•             Proactively contribute to development of Nordic IE organization

Education & Qualifications:

University degree and PhD desired in bioscience, medicine, epidemiology, and/or economics, health economics

Experience:

Extensive (at least 4 years) epidemiological experience from conducting registry/database studies including deep methodological and technical expertise desired.

In depth knowledge from clinical trial planning, setup and initiation with proven hands-on experience.

In depth knowledge and hands-on experience about the feasibility process and the global decision process behind country allocation.

Strong medical affairs background with at least 2 yrs experience as MSL/Medical Advisor within a dedicated TA

Competencies:

•             Ability to lead and manage complex research projects in collaboration with internal and external stakeholders

•             Strategic thinking, strong decision making and commitment

•             Excellent collaboration and communication skills

•             Extensive knowledge of databases/RWD sources and

Experience in building relationships with KOLs and Payors to deliver innovative and scientifically robust evidence

•             Thorough understanding of Nordic health care and access landscapes and applicable processes

•             Deep understanding of product life cycle process from early development to post-launch to deliver key evidence needs for different stakeholders

•             Well-developed understanding of Principles of Medical Research/GCP

•             High ethical standards

Language:

Fluency in English. Competency in local CPO language is also required.