Scientist, Global Medical Research

Scientist, Global Medical

Pharma Essentia Corporation is a global biopharmaceutical company with a pioneering spirit and a deep commitment to patients with rare and underserved diseases. Our lead product, BESREMi® (ropeginterferon alfa-2b), is the first FDA-approved monotherapy for polycythemia vera (PV) regardless of treatment history, and we are actively advancing our clinical and real-world evidence programs across myeloproliferative neoplasms (MPNs), including essential thrombocythemia (ET) and myelofibrosis (MF).

The Opportunity We are seeking a Scientist, Global Medical to serve as a key driver of our evidence generation strategy. This role sits at the intersection of clinical research, investigator-initiated trials, and scientific publication—translating medical strategy into published evidence that shapes clinical practice and supports guideline development.

Investigator-Initiated Trial (IIT) Management

• Lead oversight of the IIT portfolio, from concept evaluation and scientific review through study monitoring, data interpretation support, and publication collaboration
• Develop and apply rigorous evaluation criteria for IIT proposals, assessing strategic alignment, scientific merit, investigator credibility, institutional track record, and feasibility
• Serve as the primary scientific liaison with external investigators, providing scientific input on protocol design, supporting regulatory compliance awareness (CTA, IRB/EC approvals), and tracking study milestones
• Coordinate internal IIT governance processes, including concept review committees, budget and fair market value assessments, and fund disbursement oversight
• Establish and maintain a structured IIT pipeline tracker with clear stage-gating, timelines, and deliverable expectations

Clinical Trial Design & Evidence Generation

• Provide scientific input on the design and execution of company-sponsored Phase IIIb/IV and adaptive clinical studies, burden of illness studies, and real-world evidence programs
• Collaborate with clinical development, biostatistics, and regulatory teams on study design, endpoint selection, and statistical analysis plans
• Identify evidence gaps aligned with medical strategy and develop research plans to address them through RCTs, RWE, and health outcomes research
• Evaluate and integrate multiple real-world data sources—including medical records, insurance databases, prescription databases, and patient registries—into the evidence generation strategy

Scientific Publication & Dissemination

• Drive a publication strategy that produces high-impact manuscripts, congress abstracts, poster presentations, and review articles across the PV, ET, and MF therapeutic areas
• Author, co-author, and critically review manuscripts for submission to peer-reviewed journals, ensuring factual accuracy, scientific rigor, and compliance with ICMJE and GPP guidelines
• Collaborate with KOLs and academic investigators to develop consensus guidelines, journal supplements, and Delphi consensus study outputs
• Ensure all publications align with the integrated evidence plan and support NCCN guideline submissions and payer evidence needs

Cross-Functional Collaboration & Scientific Leadership

• Partner with the MSL team, Medical Affairs leadership, and Commercial Analytics & Insights to translate field insights and medical questions into actionable research hypotheses
• Support the development and maintenance of a medical question (CQ) map that links KOL insights, evidence gaps, and ongoing research activities
• Contribute scientific expertise to advisory boards, speaker programs, and internal training initiatives
• Prepare evidence summaries and data packages for executive leadership and regulatory interactions

Required Qualifications

• MD, PhD, or MD/PhD from an accredited institution; terminal degree strongly preferred
• Minimum 5 years of clinical research experience at a top-tier US academic medical institution or equivalent research-intensive environment
• Demonstrated publication track record with first-author or senior-author peer-reviewed publications in hematology, oncology, or a closely related field
• Direct experience managing investigator-initiated trials, including protocol…