Bachelor’s degree in Life Sciences required; advanced degree preferred (MS, PhD)
3+ years of clinical research experience with a PhD, 4+ years with an MS, or 5+ years with a BS
Strong scientific framework with a focus on tangible outcomes
Experience in multidisciplinary teams for process improvement
Ability to meet timelines and ensure study delivery
Responsibilities
Contribute to scientific development of clinical studies per the clinical development plan
Provide scientific input for efficient execution of programs, ensuring quality and compliance
Develop clinical documents and training materials aligned with scientific strategy
Review and interpret clinical data, assisting in writing reports and regulatory submissions
Support medical monitoring to ensure patient safety and data integrity
Manage processes for external study oversight committees
Collaborate with stakeholders to translate clinical strategy into operational deliverables
Benefits
Hybrid work environment with a minimum of 3 days onsite
Opportunity to work on impactful clinical studies
Engagement with cross-functional teams
Professional development opportunities
Supportive work culture focused on collaboration and innovation
Full Job Description
Position Overview:
The Senior Clinical Scientist will be a key member of a clinical development team supporting protocol development and study delivery. The position holder works closely with the CDT Lead and other Clinical Representatives in performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs.
Work Environment:
*** This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly. Relocation assistance and visa sponsorship are not provided
Key Responsibilities:
Under general direction, contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan
Provides scientific input for the safe, efficient, and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs
Contributes to the development of program and core clinical development documents and training materials aligned with the scientific strategy (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, investigator trainings)
Reviews clinical data with some assistance and assists with interpreting data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents
Supports medical monitoring and oversight of individual clinical studies to ensure the highest level of patient safety and data integrity
Manages the processes and interactions required to support external study oversight committees (e.g. Steering committee, independent data monitoring committee, adjudication committee)
Collaborates with internal and external cross-functional stakeholders to ensure translation of the clinical development strategy and clinical protocol into operational deliverables
Minimum Qualifications:
Bachelor’s degree, or equivalent, in a Life Sciences discipline is required
An advanced degree (MS, PhD) in a Life Sciences discipline is highly preferred
PhD with 3+ years/ MS with 4+ years or BS with 5+ years of clinical research/clinical development experience in the biotechnology or pharmaceutical industry
The successful candidate will have a strong scientific framework, coupled with ability to work towards tangible outcomes, meeting timelines and ensuring study delivery
Experience with contributing to multidisciplinary working groups to support continuous process improvement as requested
Competencies:
Thinks beyond and maintains an external and strategic focus
Builds bridges and helps teams develop collaboration
Unleashes outcomes and creates an accountable work environment
Ignites agility and instills personal flexibility in self and teams
Inspires the future and ensures clarity around the strategy
Excellent written and oral communication skills
The minimum and maximum base salary range that CSL expects to pay for this position at the Waltham, MA USA work location at the time of this posting is $146,000 - $173,000/yr. 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.
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About CSL Limited
CSL Limited is a global biotechnology company that develops and delivers innovative biotherapies and influenza vaccines to protect public health. They have a focus on rare and serious diseases, and their products are used in more than 70 countries. CSL Limited was founded in 1916 in Australia, and has since grown to become one of the largest biotech companies in the world. They have a strong commitment to research and development, and invest heavily in new technologies and therapies. CSL Limited is listed on the Australian Securities Exchange and the NASDAQ, and has a market capitalization of over $100 billion.