
Director Real World Evidence Scientist (Oncology)
<p style="text-align:justify"> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Work Your Magic with us! <span style="color:#ffffff">Start your next chapter and join EMD Serono.</span></span></span></p><p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we!
Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.
That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. </span></span></p><p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.
Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.</span></span></p><p style="text-align:justify"> </p><br><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong>Your Role:</strong></p><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">The Director, Real World Evidence Scientist is a highly experienced scientific expert who develops and owns the RWE strategy at the program(s) level, leads PRWE and CMS cross-functional initiatives, and interfaces directly with Global Program Teams (GPTs) and sub-teams.
This role provides deep scientific leadership for the RWE strategy for one complex/high-priority product or group of products — leading and executing end-to-end RWE activities, providing expert oversight of studies, and representing our organization externally — without formal line management responsibilities.</p><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong> </strong></p><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong>Key Responsibilities:</strong></p><ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Develop and own the RWE strategy at the program(s) level; interface directly with Global Program Teams (GPTs) and the subteams to integrate RWE into clinical development and regulatory strategies.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Lead PRWE and CMS cross-functional initiatives</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Ensure planning and management of outsourced deliverables are effectively performed to the highest quality and in a timely manner.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Ensure objective results interpretation and adequate internal communication in support of informative decision making at GPT, PST, and Senior Management level.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Lead and execute the RWE strategy for assigned product(s) without supervision. Provide leadership in the development of RWE strategy in Integrated Evidence Plans (IEPs) in close collaboration with cross-functional teams; ensure RWE generation needs are included in the IEP and secure budget for strategy execution.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Collaborate closely with development team functions (GPS, GRA, GMU, GVD, GCD) and commercial teams (Market Access, Marketing, GVAP) as well as within PRWE.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">For one complex/high-priority product or group of products: adequately and timely design, plan, initiate, monitor, and finalize NIS (including protocol development and study report writing); peer review key documents (protocol, study report, briefing books for Health Authorities).</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Ensure the identification and selection of fit-for-purpose RWD sources for given research questions; contribute to the RWD strategy of the assigned therapeutic area.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Solves complex or novel problems by analyzing research findings.
Interprets critical internal or external business issues and develops innovative solutions to help sustain competitive advantage</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Represent PRWE in cross-functional governance bodies; direct the RWE contribution for publications.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Represent Company in external interactions requiring RWE expertise; represent PRWE at international conferences and consortia, contribute to peer-reviewed publications, conference presentations and scientific communications.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Research and implement state-of-the-art RWE methodology; develop RWE standards focusing on efficient study designs to support sound R&D decision making.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Lead process improvement to gain efficiency in current SOPs/WIs, and develop new ones as needed; promote lean concepts; encourage and foster collaboration at all levels within PRWE.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Ensure methodological intelligence on appropriate regulations, guidance documents, and methodological developments; provide sound and up-to-date recommendations to NIS conduct.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Handle interactions with Health Authorities and manage difficult issues with limited supervision; represent the company during approval processes including defense of RWE aspects with regulatory agencies.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Provide high quality input to critical review assessments, expert statements, publications, and study proposals from internal and external sources.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Develop new processes and SOPs relevant for PRWE at Company and customize existing ones according to lean concepts.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Manage budget associated with program-level RWE projects; maintain overview of budget spend by functional and program budget.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Act as scientific mentor for less senior scientists within the function.</li></ul><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong> </strong></p><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong>Who You Are:</strong></p><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong>Minimum Qualifications:</strong></p><ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Master's or PhD in Epidemiology, Public Health, Health Economics and Outcomes Research, or Biostatistics.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">8-10 years of RWE experience in CRO, or pharmaceutical/biotechnology industry settings.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Demonstrated strong experience in studies based on secondary data use (claims, EMR, registries) across different healthcare environments (Europe, US, Asia).</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Experience in studies based on primary data collection.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Knowledge of federated data networks (CPRD, Optum, IQVIA, TriNetX) and OMOP CDM or FHIR data standards.</li></ul><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"> </p><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong>Preferred Qualifications:</strong></p><ul style="margin-bottom: 0in; margin-top: 0px;"><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Strong methodological skills; medical/pharmacological/pharmacovigilance knowledge.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Experience in project management as a global RWE leader, preferably in multi-cultural environments.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Strong expertise in drug development, including interfaces and interdependencies of clinical development with other functions.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Experience in global regulatory and/or payer submissions and interactions.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Experience in at least one key therapeutic area (Oncology, Neurology & Immunology).</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Excellent understanding of the regulatory environment and standards.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Track record of thought leadership (publications, conference presentations, advisory roles).</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Experience with AI/ML applications in RWE, including NLP.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Experience with patient-reported outcomes (PROs) and health technology assessment (HTA).</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Experience in budget oversight and vendor management in global organizations.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Knowledge of health equity and DEI principles in evidence generation.</li><li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;">Involvement in industry working groups, regulatory advisory committees, or professional society leadership</li></ul><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong> </strong></p><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><em>Pay Range for this position: $172,000 - 258,000</em><br><em>The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors.
Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.
For more information click </em><a href="https://careers.emdgroup.com/us/en/benefits" target="_self" data-di-id="di-id-4f524da1-9d3c12d3"><em>here</em></a><em>. </em> </p><br><p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>What we offer:</strong> We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology.
We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!</span></span></p><p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!</span></span></p>
Originally posted by EMD Group. View original posting
BioCareerAI is an independent job platform and is not affiliated with or endorsed by EMD Group.
