OverviewJob Summary (Primary Function):
The Director, Translational Sciences will lead a hematology and blood coagulation disease program. This is a high-impact leadership role that requires the development of biomarker strategies and translational research for use in ongoing human clinical studies related to a novel treatment for congenital bleeding disorders. The position will collaborate actively with industry and academic partners to investigate the potential utility of this novel treatment as a universal hemostatic therapy for numerous bleeding disorders. Ideal candidates are scientists who thrives at the interface of preclinical biology, clinical development, and biomarker strategy - translating mechanistic insight into first-in-human and later-stage clinical trials.
Essential Functions:
- Lead translational strategy for one or more hematology/coagulation programs, from early discovery through clinical proof-of-concept and beyond.
- Design and oversee biomarker strategies tailored to coagulation cascade biology and bleeding/thrombotic risk assessment.
- Provide ongoing data review, analysis, interpretation, and documentation required to impact key clinical development decisions.
- Partner closely with clinical partners to translate clinical and nonclinical translational findings into clinically actionable trial designs.
- Provide scientific and strategic input on companion diagnostic development where relevant.
- Represent Translational Science in regulatory interactions, including IND/CTA-enabling packages and end-of-Phase meetings, where required.
- Mentor and provide scientific leadership to scientists across the Translational Sciences organization.
- Author and review key scientific documents, including investigator brochures, protocol synopses, regulatory briefing documents, and publications.
Qualifications (Minimal acceptable level of education, work experience, and competency):
- Exceptional verbal and written communication skills.
- High level of emotional intelligence and willingness to work collaboratively with diverse functional groups, both internal and external to the company.
- Interest in working in and creating an environment of scientific curiosity and open exchange of ideas.
- Ability to balance execution and prioritize multiple tasks to accomplish program goals.
- Passion for exploration of human biology and the development of methods to study disease biology and treatment-associated biological changes.
- Dynamic and innovative scientist.
- Strong scientific background with an advanced degree, such as MD, PhD, or equivalent, and a demonstrated track record of performing excellent science.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
