Summary
✨ AI‑Generated
A senior clinical scientist role focused on advancing hematology clinical development programs and individual studies. The position involves shaping scientific strategy, contributing to study design and documentation, supporting medical monitoring, and ensuring patient safety, data integrity, quality, and regulatory compliance. The role offers hybrid work with at least three onsite days per week, while relocation assistance is not provided.
Highlights
Scientific leadership in hematology clinical development, involvement across the full study lifecycle, strong focus on patient safety and data quality, and collaboration on high-impact clinical programs.
Description
Work Environment
This is a hybrid position with a minimum of 3 days onsite required on a weekly basis.
Relocation and mobility assistance are not provided.
Main Responsibilities
Contributes to the scientific development of clinical development programs and individual studies in alignment with the clinical development plan within the Hematology therapeutic areaProvides scientific and clinical development input for the safe, efficient and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputsAuthor and/or contribute to the development of program and study level documents and training materials aigned with the scientific strategy (e.g.
clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, and investigator trainings)Contributes to the development of the medical monitoring oversight strategy for individual clinical studes and implements it to ensure the highest level of patient safety oversight and data integrity, including ongoing review of blinded dataMay lead development of Clinical Development ProgramContributes to authorship and review of manuscripts, conference abstracts, etc.
Collaborates with internal and external cross-functional stakeholders to ensure translation of the clinical developent strategy and clinical protocol into operational deliverablesContributes to the scientific analysis and interpretation of clinical data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documentsManages the process and liaisons required to support external study oversight committees (e.g.
steering committees, independent data monitoring committe, and adjudication committee)
Minimum Qualifications
PhD; Masters Degree; or Bachelor degree in a Science related discipline.
Advanced degree (MSc, PhD) in a Science related discipline is preferred as well as a PMP Certification4+ (PhD); 6+ (MS) or 8+ (BS) years of experience in one or more R&D functions in the biotechnology/pharmaceutical industry 3+ years of clinical development research experienceProven in-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs)
Competencies
The ability to work cross-functionally in a matrix environment is essentialExcellent communication skills, oral and written, are requiredGreat attention to detail in processes, communications and documentationProven ability to work independently and in a team setting is essentialAbility to think outside the box and problem-solveExperience providing oversight to CROs
The expected base salary range for this position at hiring is $168,000 - $199,000/yr.
Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the Waltham, MA USA work location at the time of this posting.
Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors.
In addition to base salary, total compensation for this role may also include incentive compensation and equity.
