Clinical Scientist (LN19-198)
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel treatments for hemophilia and other rare bleeding disorders using our potent, subcutaneous (SQ) coagulation factors that promote prophylaxis therapy. We have completed the Phase 2 trial of our subcutaneous (SQ) Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for prophylaxis. The study met the primary endpoint of significantly reducing the annualize bleed rate (ABR) in patients with hemophilia A or B with inhibitors. The study also met all secondary endpoints of safety, tolerability and lack of anti-drug antibody or inhibitor formation. We have also initiated enrollment in a Phase 2b trial of dalcinonacog alfa – DalcA, a next-generation (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B.
We are currently seeking to hire a motivated Clinical Scientist who has a love of learning, dedication to patients, and wants to meaningfully contribute to bringing new medications to fill an unmet medical need. This person will report to the Vice President Clinical Development.
- Support the Clinical team with conduct of clinical trials including protocol implementation, site identification and communication, IRB interactions, attendance at investigators’ meetings
- Support program development, including cross-functional interaction with the various disciplines necessary for successful drug development such as: pre-clinical, manufacturing, quality, regulatory, medical affairs, biostatistics and data management, pharmacovigilance, and clinical operations
- Support ongoing and end of study data review and compilation for efficacy and safety evaluation, with clinical oversight and review
- Work closely with the project and study teams to deliver enhanced efficiencies and quality around tactical deliverables, IND and other regulatory submissions, protocol development, amendments and all supporting documents, PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications.
- Key clinical participant in cross-functional sub-team meetings
- Lead the process of authorship, development, and amending clinical study protocols, assist with consent forms, case report forms and ancillary documents in collaboration with the clinical team
- Work with Clinical Operations and Data Management in database review, query and clean-up activities in real-time and prior to database lock
- Perform literature reviews and apply the learnings to the clinical development program
- Lead the clinical team in preparation of abstracts, posters, oral presentations and manuscripts
- Work with the Program Team Leader and clinical team in preparation for, and organization of, development advisory boards
- Understand regulatory requirements for drug development and apply those to regulatory documents
- Demonstrates effective oral and written communication skills in documents and in power point
- Possess excellent interpersonal skills with demonstrated ability to work successfully with a team
- Show independence, initiative and ability to work well in a fast-paced dynamic environment
- Ability to travel (approximately 10-20%) to investigative sites, regulatory agencies, and to attend major scientific and clinical meetings
- 3-5 years pharmaceutical or biotech industry experience with clinical trials
- Hemophilia or rare disease experience a plus
- PhD in applicable scientific disciplines such as Biology, Chemical/Biochemical Engineering, Biochemistry, or Chemistry
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to firstname.lastname@example.org, referencing requisition number LN19-198 in the subject line.