Principal Scientist

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

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 were 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 The 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 investigators brochures informed consent forms clinical study reports medical monitoring plans conference abstracts internal and external scientific meeting presentations and peer-reviewed publications.

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

Qualifications:

Bachelors degree or equivalent in Science Allied Health or Engineering

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

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)

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About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

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