Kedrion Biopharma

Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.

Job Summary

Drive Innovation in Rare Disease Clinical Development

We are seeking a clinical development professional with strong training and/or broad experience in rare diseases. In this role, you will collaborate closely with clinical project teams to support the medical aspects of our programs, including medical monitoring, communication with principal investigators, optimizing study designs, contributing to data readouts, reporting clinical trial results, and presenting program updates to senior leadership. You will serve as a key resource for analyzing and communicating clinical data and will integrate insights across functional areas to clearly articulate the company’s clinical development strategy to both internal and external stakeholders. Success in this role requires a highly collaborative team player committed to working seamlessly with scientific and clinical colleagues to advance our clinical programs.

What you'll do

• Serve as a Study Medical Monitor, authoring clinical trial documents including protocols, investigator brochures, ICFs, training materials, and DSURs.
• Provide clinical development support and scientific opinion to study teams.
• Contribute to the development and optimization of clinical trial study designs.
• Work closely with Clinical Operations to execute clinical trials with high quality, deliver results and meet target timelines.
• Drive contribution of clinical content for deliverables in support
• of regulatory submission activities and ensure flow and accuracy of key data for clinical module sections of the IND.
• Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plans.
• Contribute to the ongoing scientific review of clinical trial data and assist with query generation/resolution and data analysis. Work closely with PV, Data Management, and other vendors to ensure appropriate review and documentation of clinical trial data.
• Maintain scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Stay abreast of internal and external developments, trends, and other dynamics relevant to the work to maintain a fully current view.
• Develop and maintain relationships with a variety of internal and external partners and stakeholders, including clinical investigators, study coordinators/CRAs and KOLs.
  
  

Qualifications And Need-to-know

• Advanced degree required: MD, DO, PharmD, PhD, or an equivalent advanced degree in a medical, biomedical, or related scientific field
• 5+ years’ experience in clinical development with at least 2 years in the biopharmaceutical industry. Experience in translational medicine/early phase oncology clinical trials is a plus.
• Understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations.
• Proven ability to interact and work with external partners (PIs and consultants) with regards to clinical development functions.
• An understanding of the clinical trial processes, such as study start up, patient recruitment and safety, non-compliance, management, and monitoring of investigative sites.
• Excellent problem-solving skills, a strong sense of urgency and keen attention to detail. Well organized with the ability to effectively manage multiple priorities in a dynamic, cross-functional teamwork environment under time and resource pressures.
  
  

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications.

Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:

• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual
• and much more!
  
  

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com.

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.