[Hiring] Scientist, Global Medical Research @PharmaEssentia U.

Role Description

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-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.

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 development, IRB/EC submissions, and investigator engagement.
• Deep understanding of clinical trial design, biostatistics, and real-world evidence methodologies.
• Strong knowledge of regulatory requirements for clinical research, including ICH-GCP, ICMJE, and GPP guidelines.
• Proven ability to work independently, manage multiple complex projects simultaneously, and drive programs to completion with minimal supervision.
• Excellent scientific writing skills with the ability to translate complex clinical data into clear, publication-ready manuscripts and evidence summaries.

Preferred Qualifications

• Clinical or research background in hematology/oncology, with specific experience in myeloproliferative neoplasms (PV, ET, MF) or interferon-based therapies.
• Prior pharmaceutical or biotech industry experience in Medical Affairs, clinical development, or evidence generation roles.
• Experience with NCCN guideline submissions or other clinical guideline development processes.
• Experience designing and executing Delphi consensus studies or structured expert elicitation programs.
• Familiarity with health economics and outcomes research (HEOR) and value-based evidence frameworks.
• Track record of successful collaboration with KOLs and external academic investigators.
• Bilingual capabilities (English and Mandarin) are a plus but not required.

Benefits

• A high-impact role with direct visibility to executive leadership and the opportunity to shape the evidence strategy for a first-in-class therapeutic across multiple indications.
• Ownership of a growing IIT portfolio and publication pipeline in an organization committed to scientific excellence and evidence-based medicine.
• A collaborative, intellectually rigorous Medical Affairs team with a compliance-first culture and clearly defined governance structures.
• Competitive compensation, comprehensive benefits, and the flexibility of a remote-first working environment.