Jobs · OTHR

Scientist, Global Medical Research

PharmaEssentia · Burlington, MA · 2 wk ago
OTHR$150k–$205k/yrFull-time

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.

Career Development

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.

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.

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 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

What We Offer

  • 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

Benefits of Working with Our Team

  • Comprehensive medical coverage
  • Dental and vision coverage
  • Generous paid time-off
  • 401(k) retirement plan with competitive company match
  • Medical & Dependent Care Flexible Spending Account
  • Up to $150 monthly cell phone reimbursement
  • Employee Assistance Program

Equal Employment Opportunity

PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:

  • Comprehensive medical coverage
  • Dental and vision coverage
  • Generous paid time-off
  • 401(k) retirement plan with competitive company match
  • Medical & Dependent Care Flexible Spending Account
  • Up to $150 monthly cell phone reimbursement
  • Employee Assistance Program

PharmaEssentia does not accept unsolicited agency resumes.

Lie Detector Test Policy

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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