Scientist, Global Medical Research
Listed on 2026-07-08
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Research/Development
Clinical Research, Research Scientist, Medical Science
About Pharma Essentia
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).
Our pipeline includes landmark studies such as EXCEED-ET and HOPE-PMF, alongside a growing portfolio of investigator-initiated trials (IITs) and real-world evidence initiatives.
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. The ideal candidate is an accomplished clinical researcher with a strong publication track record, deep experience in hematology or oncology, and the ability to independently advance complex research programs from concept through publication.
Investigator‑InitiatedTrial (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.
- 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.
- 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.
- 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.
- MD, PhD, or MD/PhD…
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