Principal Clinical Scientist, Clinical Development - Hematology

CSL Plasma; Waltham (MA); Híbrido; USD 168.000 - 199.000; Jornada completa

Descripción de la vacante

CSL Plasma in Waltham, MA seeks an experienced leader in clinical development within the hematology field to advance scientific programs and ensure rigorous study delivery. You will contribute to development plans, monitor safety and data integrity, and collaborate across functions to translate strategy into actionable deliverables.

The role requires a PhD or higher in science, with 3+ years in clinical development research, and a track record in drug development processes and CRO oversight.

Formación

• PhD/Master/Bachelor in a science discipline; PMP preferred.
• 4+ (PhD); 6+ (MS) or 8+ (BS) years in R&D in biotech/pharma.
• 3+ years of clinical development research experience; drug development knowledge.

Responsabilidades

• Contributes to development of clinical programs within Hematology and aligns with the clinical development plan.
• Provides input for safe, efficient, timely execution of studies with high-quality outputs.
• Author or contribute to program documents, protocols, ICFs, and training materials.
• Leads development of Clinical Development Program and oversight strategies.
• Collaborates with stakeholders to translate strategy into operational deliverables.
• Supports manuscript writing, abstracts, and regulatory submission documents.
• Oversees CRO activities and data monitoring committees as needed.

Conocimientos

Communication skills

Attention to detail

Independent work

Problem solving

Cross-functional teamwork

CRO oversight experience

Educación

PhD in science

Master's in science

Bachelor's in science

PMP Certification

Descripción del empleo

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.

#LI-HYBRID