Duration: 3-6 months to start
Hours per week: 20-30
Start Date: ASAP
Job Description:
Our client is currently seeking an experienced Clinical Development Scientist to assist with the evaluation of potential new indications for the expansion of their ongoing clinical development program related to monoclonal antibodies (mAb’s). The ideal candidate will have experience in the clinical development of immune-mediated inflammatory biologics across multiple therapeutic areas such as: immunology, rheumatology, hematology. Main functions will consist of developing clinical study designs for Phase II and Phase III studies.
Key Responsibilities:
Analyze the design and results of competitor Phase 2 and Phase 3 clinical trials (endpoints, I/E criteria, results, etc)
Develop Phase 2 clinical study designs and assist with strategy plan input
Collaborate closely with Translational Research to understand the mechanism of action (MOA) of study-specific mAb product (namilumab), while identifying potential target populations.
Cross-functional cooperation with various departments to understand the regulatory requirements for clinical trials.
Gap assessments within various indications based on the efficacy of the current standard of care.
Facilitate external discussions with key personnel to develop study designs and assess competitor trials.
Requirements:
5+ years of clinical development experience in a pharmaceutical or biotech company, with 2+ years in a lead development role.
Phase 2 study design through registration-enabling clinical programs.
Global and US Clinical Trial Study expertise
Knowledge in therapeutic areas such as: immunology and inflammation (pulmonary, rheumatology, or hematology)
Experience with multi-indication assessments and clinical development strategy.
Excellent communication and interpersonal skills.
Self-driven aptitude while excelling in a team environment
Critical and innovative thinking through obstacles and study designs
Study start-up experience
Education:
MD, MD/PhD, or PharmD degree preferred
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Clinical Development Scientist (233762) Remote
