About this role
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 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, investigator’s 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:
• Bachelor's 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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our 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 https://www.csl.com/careers/inclusion-and-belonging
Equal 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 https://www.csl.com/accessibility-statement.
About CSL
Global biotech leader in plasma-derived therapies, vaccines, and iron deficiency treatments. Headquartered in Melbourne, Australia.
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