Principal Scientist

CSL Plasma•Waltham, MA

1d•Hybrid

About The Position

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Head of Pharmacovigilance Operations? The job is in our King of Prussia, PA, Waltham, MA or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will report to T he Director Clinical Scientist Lead for Hematology and Transplant. You will be responsible for scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and key stakeholders to ensure translation of the development plan into operational deliverables. Contribution to the scientific content of clinical program documents is a key deliverable and includes study synopses and protocols, investigator’s brochures, informed consent forms, clinical study reports, medical monitoring plans, conference abstracts, internal and external scientific meeting presentations, and peer-reviewed publications.

Requirements

Bachelor's degree or equivalent in Science, Allied Health or Engineering
8+ years experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization)
5+ years in managing projects
In-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs)

Nice To Haves

An advanced degree (MSc, PhD) in Science, Allied Health or Engineering, PMP Certification, Masters of Business Administration (MBA) or equivalent

Responsibilities

Provides scientific and clinical development input for the safe, efficient and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs
Will contribute to the development of the scientific strategy of the clinical development plan, the design and development of trial related documents and the scientific oversight of clinical trials
Facilitates a team to define and deliver the clinical strategy within projects and programs
Defines scientific strategy for various program components
Can lead development of Clinical Development Program
Authors clinical study documents and assists with development/critical review of submission documents
Contributes to authorship and review of manuscripts, conference abstracts, etc.
Collaboratively develops the clinical development strategy with project teams, providing input, guidance and mentorship for project teams
Contributes 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 documents