Lead scientific activities for clinical research programs supporting product development, regulatory approvals, post‑market evidence generation, and scientific communication.
Compensation
The base pay for this position is $78,000.00 – $156,000.00
Responsibilities
Lead development of clinical study protocols, protocol amendments, investigator brochures, case report forms, statistical assumptions, endpoint strategies, and clinical study reports.
Design prospective clinical studies, registries, observational studies, post‑market studies, and evidence‑generation programs supporting global regulatory and business objectives.
Serve as scientific lead for assigned clinical studies and provide strategic scientific direction throughout study planning, execution, analysis, and reporting.
Develop scientific rationale supporting study design, endpoint selection, evidence‑generation strategies, and clinical development plans.
Collaborate with biostatistics to review statistical analysis plans and interpret primary, secondary, subgroup, sensitivity, and safety analyses.
Requirements
Bachelor's degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or related scientific discipline.
An individual contributor role leading multiple biostatistical activities covering all phases of clinical development, translating R&D objectives into work products and establishing statistical strategies.
Compensation
$264,000 - $322,000 per year
Responsibilities
Represent and lead the statistics function within Madrigal program teams, working cross-functionally to drive program clinical development strategy
Oversee and coordinate with other biostatisticians/programmers either within Madrigal or at a CRO in support of executing R&D activities
Contribute to clinical/regulatory strategies, submission documents and lifecycle management activities to ensure the company’s clinical programs and data assets are optimally designed and executed
Perform complex statistical analyses, contribute to protocol development and prepare Statistical Analysis Plans
Represent the company in external scientific and industry forums. Engages in interactions with both external clinical and statistical thought leaders
Requirements
Ph.D. in Statistics or Biostatistics
Nice to have: Experience meeting with health authorities (FDA, EMA, PMDA)
Lead clinical science for late-stage respiratory studies, driving protocol development, data analysis, regulatory documentation, and cross-functional collaboration.
Locations (2)
Somerville, Massachusetts, United States
Andover, Massachusetts, United States
Compensation
$186,000—$279,000 USD
Responsibilities
Serve as clinical science lead and core member of clinical development team for one or more respiratory studies
Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements
Act as a key scientific contributor to late-stage protocols and regulatory submissions
Design and develop clinical trial protocols and associated documents
Drive development of clinical components of regulatory documents
Senior Medical Writer responsible for creating and managing clinical manuscripts, abstracts, posters, and client presentations across therapeutic areas.
Responsibilities
Mentors and leads less experienced medical writers on complex projects
Acts as lead for assigned writing projects
Manages medical writing activities associated with individual studies
Develops or supports a variety of documents including clinical journal manuscripts, abstracts, posters, and client presentations
Identifies and proposes solutions to resolve issues during the writing process
Lead the development and delivery of real‑world evidence and health outcomes research for US oncology products, ensuring high‑quality evidence supports product positioning and pricing.
Locations (2)
Philadelphia, Pennsylvania, United States
Durham, North Carolina, United States
Responsibilities
Develop and execute evidence generation plans and study protocols
Lead day‑to‑day management of RWE/HO studies
Report progress to stakeholders
Build relationships with external thought leaders
Manage vendors and budgets
Requirements
Master’s degree or PhD in health economics and outcomes research, epidemiology, public health, biostatistics, or related discipline
Lead the clear and accurate completion of medical writing deliverables for sponsor-dedicated projects across multiple countries.
Responsibilities
Leads the clear and accurate completion of medical writing deliverables
Manages medical writing activities associated with individual studies
Coordinates medical writing activities within and across departments
Leads the resolution of comments from the client
Completes a variety of documents including clinical study protocols, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
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