Associate Director, CRS (DG)
Southern, NJ - Pharmaceutical & Biotech - Hybrid - Full time
Date Posted: 10/26/2023
Associate Director, Clinical Research Scientist
Southern, NJ - Hybrid (3 days per week onsite)
$190-200k base target, 20% bonus, 20% equity
International biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for Oncology areas.
The Associate Director, Clinical Research Scientist serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including clinical trial implementation, and oversight of all aspects of clinical development) working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables.
Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds. Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP). Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (i.e., protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support registration and commercialization of the compound(s). Contributes to the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g., database lock activities). Lead the development of medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis. Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction. Prepare charters and coordinate internal/external committee meetings including presentation preparation (i.e., Dose Escalation, DMC, Steering Committee, Safety). Participate in the development and review of study plans and serve as a liaison to project teams and CROs. Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted. Provide input for the development of publications in coordination with Scientific Communications. Perform training at Investigator meetings, CRO/CRA training, SIVs as warranted.
PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline. Minimum of 8 years of experience in clinical research with at least 4 or more years of drug development experience. Prior oncology/hematology drug development experience is a plus. Proven skills from working in a project oriented matrixed team environment. Excellent oral, written, and interpersonal (communication) skills. Ability to travel, as needed.
Please contact Darren Gutowski at firstname.lastname@example.org