Medical Director, Clinical Development (LN19-196)
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 an experienced Medical Director, Clinical Development who will report to the Vice President of Clinical Development. The Medical Director is a critical member of our team who will focus on the execution of our clinical strategy. Key responsibilities include but are not limited to, cross functional teamwork, strategic alignment with internal and external stakeholders, protocol development and execution, KOL relationship management and medical monitoring.
- Act as a product and disease area expert and point of contact for other members of the team, working cross functionally with all the disciplines engaged in drug development activities, such as pre-clinical, CMC, QA,, regulatory, medical affairs, biostatistics/data management, pharmacovigilance, medical writing, and clinical operations.
- Design and execute clinical trials
- Support writing clinical trial protocols
- Serve as a Medical Monitor for clinical trials, which could include assistance with site identification and communication, attendance at investigator meetings, development and participation in advisory boards, and data review
- Assist with development of EDC, data analysis and presentation internally and externally
- Contribute to drafting and reviewing clinical documents, abstracts, presentations, manuscripts, and regulatory submissions, such as investigator brochures, clinical study reports, protocols, IND’s, BLA’s, MAA’s and informed consent forms.
- Cultivate relationships with key opinion leaders to represent the interests of the company
- Work closely with Regulatory affairs in communications with health authorities, briefing books, and regulatory pathway submissions
- Excellent communication skills (interpersonal, written and verbal)
- Must be well organized, polished, proactive, detail-oriented, mature and have a professional demeanor
- Ability to multi-task and work efficiently in an environment with changing priorities
- Demonstrate independence
- Act with the highest integrity
- Experience in a start-up environment
- Travel time is 15-20% to investigative and CRO sites, regulatory agencies, and hematology meetings
Education and Training
- Medical Degree required
- At least 5 years of industry or academic experience; at least 3 years of experience with clinical trial design and execution
- Experience in rare disease, especially benign hematology and hemophilia is preferred
- Specialty training in hematology a plus