Principal Clinical Scientist, Clinical Development - Hematology

CSL Ltd. ADR; King of Prussia (PA); Hybrid; USD 168,000 - 199,000; Full time

Job summary

CSL Behring is seeking a senior Clinical Development professional to contribute to hematology program science and study-level documentation. You will guide safety oversight, data interpretation, and cross-functional collaboration across internal and external partners.

A strong background in clinical development and regulatory affairs is required. Relocation is not provided; the role is hybrid with a minimum of three onsite days weekly in the United States.

Qualifications

• PhD, MSc or BSc in a science-related discipline, advanced degrees preferred with PMP certification.
• 4+ years (PhD); 6+ years (MS); or 8+ years (BS) in one or more R&D functions in biotech/pharma.
• 3+ years of clinical development research experience.
• Deep knowledge of drug development and manufacturing processes (CMC, non-clinical, clinical, Regulatory Affairs).

Responsibilities

• Contributes to scientific development of clinical programs and studies in Hematology.
• Provides input for safe, efficient, timely execution with high quality and compliance.
• Author/contribute to program and study documents (CDP, IB, protocols, eCRF, ICF).
• Develops medical monitoring oversight strategy to ensure patient safety and data integrity.
• May lead development of Clinical Development Program.
• Contributes to manuscripts, abstracts, and conference publications.
• Collaborates with cross-functional stakeholders to translate strategy into deliverables.
• Contributes to analysis and interpretation of clinical data and regulatory submissions.
• Manages liaisons to support external study oversight committees.

Education

PhD/Masters/BSc in science

R&D experience in biotech/pharma

Clinical development experience

Drug development knowledge (CMC, non-clinical, clinical, regulatory)

Job description

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 area
• 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
• Author 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 data
• May lead development of Clinical Development Program
• Contributes 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 deliverables
• 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
• Manages 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 Certification
• 4+ (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 experience
• Proven 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 essential
• Excellent communication skills, oral and written, are required
• Great attention to detail in processes, communications and documentation
• Proven ability to work independently and in a team setting is essential
• Ability to think outside the box and problem-solve
• Experience 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.

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 .